[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"high-grade-b-cell-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:high-grade-b-cell-lymphoma":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,25,0,[8,55,82,115,141,163,210,240,273,300,331,355,376,400,441,466,495,526,549,573,600,635,661,691,715],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":34,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100426707","phase-1-study-of-efficacy-and-safety-of-crc01-in-adult-large-b-cell-lymphoma-and-b-cell-acute-lymphoblastic-leukemia-patients-100426707",false,"NCT04836507","Study of Efficacy and Safety of CRC01 in Adult Large B-cell Lymphoma and B-cell Acute Lymphoblastic Leukemia Patients","An Open-label, Multi-center, Single-arm Phase 1\u002F2 Study to Assess Tolerability, Safety and Efficacy of CRC01 in Adult Patients With Relapsed or Refractory Large B-cell Lymphoma and B-cell Acute Lymphoblastic Leukemia","Cohort A:\n\nInclusion Criteria:\n\n1. ≥ 19 years of age and provided written informed consent\n2. Histologically confirmed following large B-cell lymphomas according to the World Health Organization classification 2017\n\n   * Diffuse large B-cell lymphoma, not otherwise specified Including Large cell transformation from follicular lymphoma (Transformed follicular lymphoma)\n   * High-grade B-cell lymphoma, not otherwise specified\n   * High-grade B-cell lymphoma with double-hit\u002Ftriple-hit\n   * Primary mediastinal large B cell lymphoma\n3. Relapsed or refractory disease after ≥ two lines of chemotherapy including rituximab, anthracycline and either having failed autologous Hematopoietic stem cell transplantation (ASCT) or being ineligible for or not consenting to ASCT.\n4. At least one measurable lesion (Long diameter ≥ 1.5cm)\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n6. Adequate renal and hepatic functions based on the laboratory test results\n\n   * Total Bilirubin ≤ 2.0mg\u002FdL with the exception of patients with Gilbert-Meulengracht syndrome; patients with Gilbert-Meulengracht syndrome may be included if their total bilirubin is ≤ 3 X ULN and direct bilirubin ≤ 1.5 X ULN.\n   * Aspartate transaminase (AST) and Alanine transaminase (ALT) ≤ 3 X Upper Limit of Normal (ULN) for age with exception of liver metastasis; patients with liver metastasis may be included if their AST and ALT are ≤ 5 X ULN.\n   * Serum creatinine ≤ 1.5 X ULN\n   * Estimated Glomerular Filtration Rate (eGFR) ≥ 60mL\u002Fmin\u002F1.73m2\n7. Adequate hematologic function without transfusions within 2 weeks prior to screening for the study defined as followings:\n\n   * Hemoglobin \\> 8.0g\u002F㎗\n   * Absolute Neutrophil Count (ANC) \\> 1,000\u002F㎕\n   * Absolute Lymphocyte Count (ALC) ≥ 300\u002F㎕\n   * Platelets ≥ 50,000\u002F㎕\n8. Must have a minimum level of pulmonary reserve defined as;\n\n   * ≤ Grade 1 dyspnea per Common terminology criteria for adverse events (CTCAE) v5.0\n   * pulse oxygenation \\> 91% on room air\n9. Hemodynamically stable, without pericardial effusion and Left Ventricle Ejection Fraction (LVEF) ≥ 50% confirmed by Echocardiogram (ECG) or Multigated Radionuclide Angiography (MUGA)\n10. Must have an apheresis product of non-mobilized cells accepted for manufacturing\n11. Life expectancy ≥ 12 weeks\n12. Women of child-bearing potential and all male participants must agree to use highly effective methods of contraception for at least 12 months following CRC01 infusion and until CRC01 are no longer present by PCR on two consecutive tests\n\nExclusion Criteria:\n\n1. Patients with the following medical history\n\n   * Previous or concurrent malignancy with the following exceptions:\n\n     * Adequately treated basal cell or squamous cell carcinoma without evidence of recurrence for at least 3 years prior to the study\n     * In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to the study\n     * A primary malignancy which has been completely resected and in complete remission for ≥ 5 years\n   * Unstable angina and\u002For myocardial infarction within 12 months prior to screening\n   * Thromboembolic events, pulmonary embolism or bleeding diatheses within 6 months prior to screening\n   * Hypoxemia, significant pleural effusion or significant EKG findings within 6 months prior to the screening\n2. Patients with the following concurrent disease at screening:\n\n   * Central Nervous System (CNS) involvement by malignancy by MRI at screening\n   * Active infection with hepatitis B (HBsAg positive. But, in case of HBcAb IgG positive, the patient can be enrolled in this study if he\u002Fshe takes prophylactic anti-viral agent.)\n   * Active infection with hepatitis C (HCV RNA positive)\n   * Human immunodeficiency virus (HIV) positive\n   * Active neurological auto-immune or inflammatory disorder (e.g. Guillain Barre Syndrome, Amyotrophic Lateral Sclerosis)\n   * Ventricular tachycardia and atrial fibrillation with rapid ventricular response not controlled with medical treatment within 3 months prior to screening\n3. Rapidly progressing the disease as per investigator's discretion\n4. Had major surgery requiring general anesthesia or mechanical ventilation within 4 weeks prior to screening (For video-assisted thoracoscopic surgery (VATS) or open-and-closed (ONC) surgery can be applied with within 2 weeks prior to screening.)\n5. Severe infection requiring anti-bacterial, anti-fungal or anti-viral medication or uncontrolled active infection\n6. The following treatment history is excluded:\n\n   * Prior treatment with any prior anti-CD19\u002Fanti-CD3 therapy or any other anti-CD19 therapy\n   * Prior treatment with any adoptive T cell therapy\n   * Treatment with any prior gene therapy product\n   * Prior allogeneic HSCT\n   * Patients on oral anticoagulation therapy\n7. Eligible for and consenting to ASCT\n8. Use of investigational medicinal product\u002Fdevice within 4 weeks prior to screening\n9. Pregnant or lactating women\n10. Hypersensitivity reaction to the excipients of CRC01 cell product\n11. The following treatments are excluded:\n\n    * Anti-neoplastic therapies including chemotherapy, biologic agents, retinoid therapy, radiotherapy, immune therapy, hormonal therapy, etc. other than lymphodepleting chemotherapy within 2 weeks of leukapheresis and within 2 weeks of CRC01 infusion\n    * Steroids: therapeutic doses of steroids must be stopped \\> 7 days prior to leukapheresis and \\> 5 days prior to CRC01 infusion. However, the following physiological replacement doses of steroids are allowed: \\\u003C 6 mg\u002Fm2\u002Fday hydrocortisone or equivalent\n    * Immunosuppression: any immunosuppressive medication must be stopped \\> 4 weeks prior to leukapheresis and \\> 4 weeks prior to CRC01 infusion\n    * Antibody use including anti-CD20 therapy within 4 weeks prior to CRC01 infusion\n    * CNS disease prophylaxis must be stopped \\> 1 week prior to CRC01 infusion (e.g. intrathecal methotrexate)\n\nCohort B :\n\nInclusion Criteria :\n\n1. ≥ 19 years of age and provided written informed consent to voluntarily participate in this trial\n2. Relapsed or refractory B-cell lymphoblastic leukemia with one of the following:\n\n   * Primary refractory: Newly diagnosed and refractory to 2 or more cycles of standard chemotherapy\n   * Relapsed within 12 months of the first complete remission\n   * Chemorefractory: Refractory to 1 cycle of chemotherapy conducted after relapse\n   * Relapsed after or refractory to two or more lines of chemotherapy\n   * Relapsed or refractory 100 days after allogeneic HSCT\n3. (within 4 weeks prior to screening) Blast of \\> 5% identified in the BM\n4. (within 4 weeks prior to screening) BM or peripheral blood blast confirmed CD19-positive.\n\n   Specifically, those with prior treatment with any other anti-CD19 therapy must be confirmed to show CD19 ≥ 90%.\n5. Philadelphia chromosome positive with one of the following:\n\n   * Unable to take tyrosine kinase inhibitors (TKIs) due to side effects\n   * Relapsed or refractory despite treatment with two or more TKIs\n6. ECOG performance status of 0-1\n7. Confirmed adequate hematologic function defined as follows:\n\n   * Absolute neutrophil count (ANC) ≥ 500\u002FμL. However, exceptions are made in cases where the Investigator determines that cytopenia is related to the leukemia and may be recovered with leukemia treatment.\n   * Platelet count ≥ 50,000\u002FμL. However, exceptions are made in cases where the Investigator determines that cytopenia is related to the leukemia and may be recovered with leukemia treatment.\n   * Absolute lymphocyte count ≥ 200\u002FμL\n8. Adequate renal and hepatic functions confirmed based on the laboratory test results:\n\n   * Total Bilirubin ≤ 2.0 mg\u002FdL (for patients with Gilbert-Meulengracht syndrome, total bilirubin ≤ 3 × ULN and direct bilirubin ≤ 1.5 × ULN)\n   * AST and ALT ≤ 3 × ULN\n   * Serum creatinine ≤ 1.5 × ULN or eGFR\\* ≥ 45 mL\u002Fmin\u002F1.73 m2 \\*MDRD-GFR (mL\u002Fmin\u002F1.73 m2) = 186 × (serum creatinine)-1.154 × (age)-0.203 (× 0.742 for females)\n9. Confirmed to have a minimum level of pulmonary reserve according to the following criteria:\n\n   * ≤ Grade 1 dyspnea per CTCAE v5.0\n   * Pulse oxygenation \\> 91% on room air\n10. Hemodynamically stable, without pericardial effusion, and LVEF ≥ 50% confirmed by ECHO or MUGA scan at Screening\n11. Capable of obtaining through leukapheresis non-mobilized cells adequate for CRC01 manufacturing\n12. Life expectancy of ≥ 12 weeks\n13. Consented to comply with the site visit and test schedules for Primary Follow-up and Secondary Follow-up in accordance with the Protocol for the duration of the Study\n14. WOCBP or male subjects who are willing to use appropriate contraceptive methods\\* for at least 12 months following CRC01 treatment and until CRC01 is no longer detected through two consecutive PCR tests \\* Hormonal contraceptives, placement of intrauterine system, double barrier method (simultaneous use of contraceptive vaginal diaphragm or cervical cap and male condom, along with spermicide), sterilization (vasectomy, bilateral tubal ligation), etc.\n\nExclusion Criteria:\n\nPatients in Cohort B may not participate in this trial if any of the following criteria apply.\n\n1. Patients with the following medication or treatment history:\n\n   ① Donor lymphocyte infusion (DLI) within 4 weeks\n   * Graft-versus-host-disease (GVHD) treatment within four weeks (In case of maintaining medication for post-treatment prophylaxis, the decision on the subject's participation in the clinical trial may be made after contacting and consulting with the Sponsor's Medical Monitor.)\n\n     * Central nervous system (CNS) radiotherapy or intracerebrospinal antineoplastic therapy within eight weeks (However, intrathecal therapy for prophylaxis purposes is an exception) ④ Systemic salvage chemotherapy that includes TKI and blinatumomab for treatment of Philadelphia positive ALL within one week prior to Screening or five half-lives of the administered drug (whichever is shorter)\n\n       * Any prior anti-CD19 treatment (with the exception of blinatumomab) ⑥ History of neurological toxicity ≥ Grade 4 or cytokine release syndrome (CRS) ≥ Grade 4 per CTCAE during prior anti-CD19 treatment\n2. Patients with the following CNS abnormality:\n\n   ① CNS-3 disease, defined by WBC ≥ 5\u002FμL in CSF and confirmed presence of lymphoblast, with or without neurological symptoms\n\n   ② CNS-3 disease, defined by WBC \\\u003C 5\u002FμL in CSF and confirmed presence of lymphoblast, with neurological symptoms (cases of CNS-1 disease without evidence of leukemia involvement in CSF and CNS-2 disease without neurological symptoms may be enrolled)\n\n   ③ Current or prior history of CNS disorder, such as epilepsy\u002Fseizure, cerebrovascular ischemia\u002Fbleeding, dementia, cerebellar disorder, autoimmune disease with CNS invasion, posterior reversible encephalopathy syndrome (PRES) or cerebral edema\n3. Burkitt's lymphoma\u002Fleukemia per WHO Classification or chronic myelogenous leukemia lymphoid blast crisis\n4. Primary immunodeficiency\n5. Hereditary diseases (e.g., Fanconi anemia, Kostmann syndrome, and Shwachman-Diamond syndrome) or other bone marrow failure syndromes\n\n2\\. Common Exclusion Criteria\n\nSubjects in Phase 1 study and Phase 2 study may not participate in this trial if any of the following criteria apply.\n\n1. Patients with the following medical history:\n\n   * History of malignancy with the following exceptions:\n\n     • Basal cell or squamous cell skin cancer treated without relapse for at least three years prior to Screening\n\n     • In-situ carcinoma of the cervix or breast treated without relapse for at least 3 years prior to Screening\n     * Superficial bladder cancer treated without relapse for at least 3 years prior to Screening\n     * A primary malignancy which has been completely resected and in complete remission for ≥ 5 years\n\n       * Unstable angina and\u002For myocardial infarction within 12 months prior to Screening ③ Thromboembolic events, pulmonary embolism or bleeding diatheses within 6 months prior to Screening\n\n         * Hypoxemia, clinically significant pleural effusion or clinically significant ECG findings within 6 months prior to Screening\n2. Patients with the following concurrent disease at Screening:\n\n   * Central nervous system (CNS) involvement by malignancy by magnetic resonance imaging (MRI) at Screening. However, for Cohort B, subjects with malignant tumor metastasis to the brain parenchyma confirmed by MRI scan.\n\n     * Active infection with hepatitis B confirmed (HBsAg positive at Screening. But, in case of HBcAb IgG positive, the patient can be enrolled if he\u002Fshe takes prophylactic anti-viral agent.)\n\n       * Active infection with hepatitis C confirmed (HCV Ab tested positive at Screening. But, if screened negative for HCV RNA, the patient can be enrolled.) ④ Known human immunodeficiency virus (HIV) positive ⑤ Active neurological auto-immune or inflammatory disorder (e.g., Guillain Barre syndrome, amyotrophic lateral sclerosis) ⑥ Ventricular tachycardia and atrial fibrillation with rapid ventricular response not controlled (i.e., relapsed or symptomatic) with pharmacological treatment within three months prior to Screening\n3. Showing rapid progression of study disease as per Investigator's discretion\n4. Had major surgery requiring general anesthesia or mechanical ventilation within four weeks prior to Screening (for video-assisted thoracoscopic surgery (VATS) or open-and-closed (ONC) surgery, within two weeks prior to Screening)\n5. Severe infection requiring anti-bacterial, anti-fungal or anti-viral medication or uncontrolled active infection at Screening\n6. Use of other investigational medicinal products\u002Fdevices within 4 weeks prior to Screening\n7. Pregnant or lactating women\n8. Hypersensitivity reaction to the ingredients of the Investigational Product\n\nOther protocol-related inclusion\u002Fexclusion may apply.","ALL","19 Years",{"count":19,"type":20},91,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a multi-center, phase I\u002FII study to determine the efficacy and safety of CRC01 in adult patients with relapsed or refractory large B-cell lymphoma and B-cell Acute Lymphoblastic Leukemia.",[27,28,29,30,31,32,33],"Relapsed Large B-cell Lymphoma","Refractory Large B-cell Lymphoma","Diffuse Large B-cell Lymphoma (DLBCL)","Primary Mediastinal Large B-Cell Lymphoma (PMBCL)","High-grade B-cell Lymphoma","Transformed Follicular Lymphoma (TFL)","ALL (Acute B-Lymphoblastic Leukemia)",[35,36,37,38,39,40,41],"CRC01","anti-CD19 CAR-T","CAR-T","CAR T cells","Chimeric antigen receptor","PD-1 knock down","TIGIT knock down","RECRUITING","2026-06-29",{"date":45,"type":46},"2026-07-01","ACTUAL",{"date":48,"type":46},"2021-03-02",{"date":50,"type":20},"2030-09-26",{"name":52,"class":53},"Curocell Inc.","INDUSTRY",2,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":21,"phases":65,"briefSummary":66,"conditions":67,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":81},"100517310","phase-1-testing-the-combination-of-anti-cancer-drugs-mosunetuzumab-polatuzumab-vedotin-and-lenalidomide-for-the-treatment-of-relapsedrefractory-diffuse-large-b-cell-lymphoma-100517310","NCT06015880","Testing the Combination of Anti-cancer Drugs Mosunetuzumab, Polatuzumab Vedotin, and Lenalidomide for the Treatment of Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma","A Phase 1 Study of Mosunetuzumab With Polatuzumab Vedotin and Lenalidomide (M+Pola+Len) in Relapsed\u002FRefractory (R\u002FR) Diffuse Large B-Cell Lymphoma (DLBCL)","Inclusion Criteria:\n\n* Patients must have histologically confirmed DLBCL NOS, high-grade B-cell lymphoma, or transformed indolent lymphoma as per the World Health Organization 2022 criteria\n* All patients will have relapsed\u002Frefractory DLBCL after 1 or more prior lines of therapy with the exception of patients receiving CAR T in second line that have a D score of 3 at day (D)+ 30 through D+ 90\n* Patients who progressed\u002Frelapsed after prior polatuzumab vedotin are allowed\n* For the expansion cohorts only: cohort A must have Deauville score of ≥ 3 with the first 90 days) after standard of care chimeric antigen receptor (CAR) T-cell therapy; cohort B- other patients with relapsed\u002Frefractory after 1 or more prior lines of therapy (e.g. relapse after Day 90 from CAR-T, or relapsed after other therapies and were not considered candidates for CAR-T)\n* All patients that have failed 1 line of therapy will be eligible with the exception of a 12 patient cohort (A) that will require prior CAR T therapy\n* Measurable disease by CT or PET scan, with one or more sites of disease \\>= 1.5 cm in longest dimension\n* Age \\>= 18 years\n\n  * Because no dosing or adverse event data are currently available on the use of mosunetuzumab in combination with polatuzumab vedotin, and lenalidomide in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2 (Karnofsky \\>= 60%)\n* Life expectancy \\>= 12 weeks\n* Absolute neutrophil count \\>= 1,000\u002FmcL\n* Platelets \\>= 50,000\u002FmcL without transfusion for 2 weeks prior to cycle 1 day 1 (C1D1)\n* Hemoglobin \\>= 9 g\u002FdL\n* Total bilirubin =\\\u003C 1.5 × institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level =\\\u003C 3 × ULN may be enrolled)\n* Aspartate transaminase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002F alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase \\[SGPT\\]) =\\\u003C 3 × ULN (AST and\u002For ALT =\\\u003C 5 × ULN for patients with liver involvement)\n* Alkaline phosphatase =\\\u003C 2.5 × ULN (=\\\u003C 5 × ULN for patients with documented liver involvement or bone metastases)\n* Creatinine clearance \\>= 30 mL\u002Fmin\u002F1.73 m\\^2 by Cockcroft-Gault: (140- age) × (weight in kg) × (0.85 if female) 72 × (serum creatinine in mg\u002FdL)\n* International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =\\\u003C 1.5 × ULN (This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation, such as low-molecular-weight heparin or warfarin, should be on a stable dose.)\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n\n  * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients with treated brain metastases are eligible if follow-up brain imaging 6-8 weeks after central nervous system (CNS)-directed therapy shows no evidence of progression or CNS lymphoma\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating eggs, as defined below:\n\n  * Women must remain abstinent or use contraceptive methods with a failure rate of 1% per year during the treatment period and for 3 months after the final dose of mosunetuzumab, 3 months after the final dose of polatuzumab vedotin, and 1 month after the last dose of lenalidomide\n  * For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined below:\n  * With female partners of childbearing potential, men must remain abstinent or use a condom during the treatment period, 5 months after the final dose of polatuzumab vedotin, and 1 month after the last dose of lenalidomide\n* Some concurrent cancer therapeutics (e.g., prostate, breast hormonal-based therapy) are allowed\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n* Agree to comply with all local requirements of the lenalidomide risk minimization plan\n\nExclusion Criteria:\n\n* Plasmablastic lymphoma, primary mediastinal B-cell lymphoma, gray zone lymphoma\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia\n* Patients who are receiving any other investigational agents or treatments\n* Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he\u002Fshe were to participate in the study or confounds the ability to interpret data from the study\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to mosunetuzumab or other agents used in study\n* Patients with uncontrolled intercurrent illness\n* Uncontrolled or known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (defined as ongoing signs\u002Fsymptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy and\u002For other treatment) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to first study treatment administration\n* Active CNS involvement or detectable disease by lymphoma, including leptomeningeal involvement\n* Pregnant women are excluded from this study because mosunetuzumab is bispecific antibody with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with mosunetuzumab, breastfeeding should be discontinued if the mother is treated with mosunetuzumab. These potential risks may also apply to other agents used in this study. Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of mosunetuzumab, 3 months after the final dose of polatuzumab vedotin, and 1 month after the final dose of lenalidomide\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2 or better\n* Known or suspected chronic active Epstein-Barr virus (EBV) infection\n* Patients with any other significant condition(s) that would make this protocol unreasonably hazardous\n\n  * Current \\> grade 1 peripheral neuropathy\n  * Prior solid organ transplantation\n  * Patients with known or suspected history of hemophagocytic lymphohistiocytosis (HLH)\n  * Patients with history of confirmed progressive multifocal leukoencephalopathy (PML)\n  * Currently active or uncontrolled autoimmune disease\n\n    * Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\n    * Patients with controlled type 1 diabetes mellitus who are on an insulin regimen are eligible for the study\n    * Patients with a history of disease-related immune thrombocytopenic purpura, autoimmune hemolytic anemia, or other stable autoimmune diseases may be eligible","18 Years",{"count":64,"type":20},30,[23],"This phase I trial studies the side effects and best dose of mosunetuzumab when given together with polatuzumab vedotin and lenalidomide in treating patients with diffuse large B-cell lymphoma (DLBCL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Mosunetuzumab and polatuzumab vedotin are monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread. Polatuzumab, linked to a toxic agent called vedotin, attaches to CD79B positive cancer cells in a targeted way and delivers vedotin to kill them. Lenalidomide may stimulate or suppress the immune system in different ways and stop cancer cells from growing and by preventing the growth of new blood vessels that cancer cells need to grow. Giving mosunetuzumab with polatuzumab vedotin and lenalidomide may work better in treating patients with relapsed\u002Frefractory DLBCL.",[68,69,70],"Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","High Grade B-Cell Lymphoma","Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma","2026-06-16",{"date":73,"type":46},"2026-06-17",{"date":75,"type":46},"2024-05-20",{"date":77,"type":20},"2027-06-30",{"name":79,"class":80},"National Cancer Institute (NCI)","NIH",8,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":94,"conditions":95,"keywords":98,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":81},"100574902","phase-2-a-study-of-glofitamab-based-treatment-in-people-with-diffuse-large-b-cell-lymphoma-100574902","NCT06765317","A Study of Glofitamab-based Treatment in People With Diffuse Large B-cell Lymphoma","Optimizing Frontline Therapy for DLBCL in Older Adults: A GLOfitamab-based, Response-adapted, Window-stYle Study (GLORY)","Inclusion Criteria:\n\n1. Age 65-79 years with a fitness assessment of unfit or frail per simplified GA (Appendix 1, www.filinf.it\u002Fepi)\n2. Age ≥80 years with any fitness level\n3. Pathologically confirmed DLBCL, HGBCL or transformed lymphoma\n4. No prior systemic anti-lymphoma therapy (prednisone\u002Fequivalent up to 100 mg daily x 7 days is permissible)\n5. Ann Arbor Stage 2 bulky, 3 or 4 disease (Appendix 1)\n6. Any IPI score (Appendix 1)\n7. Anthracycline eligible: LVEF ≥ 45% by echocardiogram or MUGA scan.\n8. Must have at least one bi-dimensionally measurable lesion (\\>1.5 cm in its largest dimension for nodal lesions, or \\>1.0 cm in its largest dimension for extranodal lesions by computerized tomography \\[CT\\] scan or MRI)\n9. Eastern Cooperative Oncology Group performance status ≤ 2 (Appendix 1)\n10. Must have adequate organ and marrow status:\n\n    1. Absolute neutrophil count (ANC) ≥1,000\u002Fmm3 or ≥500\u002Fmm3 if due to disease involvement in the bone marrow\n    2. Platelet count ≥50,000 cells\u002Fmm3 or ≥25,000\u002Fmm3 if due to disease involvement in the bone marrow\n    3. Patients who do not meet criteria for bone marrow function due to marrow involvement of lymphoma and\u002For other disease-related cytopenias (e.g., immune thrombocytopenia) may be enrolled into the study after discussion with, and confirmation by the PI.\n    4. Serum creatinine ≤ULN OR estimated Creatinine Clearance (CrCl) ≥30 mL\u002Fmin (Cockcroft-Gault formula or other institutional standard methods)\n    5. Serum aspartate transaminase (AST) or alanine transaminase (ALT) ≤3 x upper limit of normal (ULN)\n    6. Total bilirubin ≤ 1.5 x ULN (≤3 if due to Gilbert's syndrome or liver involvement by the lymphoma\n    7. Patients who do not meet criteria for liver function due to liver involvement of lymphoma may be enrolled into the study after discussion with, and confirmation by the PI.\n11. Negative HIV test at screening, with the following exception: Individuals with a positive HIV test at screening are eligible provided, prior to enrollment, they are stable on antiretroviral therapy, have a CD4 count ≥200\u002FµL, and have an undetectable viral load.\n12. Signed Informed Consent Form(s)\n13. Ability to comply with all the study-related procedures, in the investigator's judgement\n14. Female patients who are not of child bearing potential (i.e., who are postmenopausal or surgically sterile). For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agree to refrain from donating sperm, as defined below: With a female partner of childbearing potential or pregnant female partners, male participants must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C 1% per year during the treatment period and for at least 6 months after pretreatment with obinutuzumab, 6 months after the last dose of polatuzumab, 160 days after the last dose of rituximab, 2 months after the final dose of glofitamab or 2 months after the last dose of tocilizumab (as applicable), whichever is longer. Male participants must refrain from donating sperm during this same period. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the individual. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception. If required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form.\n\nExclusion Criteria:\n\n1. Prior systemic anti-lymphoma therapy (localized radiation, steroids and antibiotics are permitted)\n2. Prior solid organ transplantation\n3. Prior allogeneic stem cell transplantation\n4. Active CNS involvement\n5. Uncontrolled HIV or active HBV or HCV infection (controlled HIV with undetectable viral load and previously treated HBV and HCV are allowed) 5.1 Participants with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus (HBV) DNA is undetectable at the time of screening. Such participants must be willing to undergo HBV DNA testing on Day 1 of every cycle and every 3 months for at least 12 months after the final cycle of study treatment and appropriate antiviral therapy as indicated.\n\n   5.2 Participants positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA\n6. Uncontrolled active systemic infection\n7. Major surgery within 4 weeks of the first dose of study drug (exceptions may be allowed after discussion with PI if patient has fully recovered from procedure and antilymphoma therapy is urgently needed)\n8. Significant or extensive history of cardiovascular disease such as New York Heart Association Class III or IV cardiac disease or Objective Assessment Class C or D, myocardial infarction within the last 3 months prior to the start of Cycle 1, unstable arrhythmias, or unstable angina.\n9. Uncontrolled autoimmune disorder\n10. A history of confirmed progressive multifocal leukoencephalopathy\n11. Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or risk study outcomes\n12. Inability to comply with all the study-related procedures, in the investigator's judgement.\n13. Contraindication to any of the individual components of polatuzumab, R-miniCHP and glofitamab or history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products\n14. Prior treatment with systemic immunotherapeutic agents, including but not limited to, radio-immuno-conjugates, antibody-drug conjugates, immune\u002Fcytokines and monoclonal antibodies (mAbs) (e.g., anti-cytotoxic T lymphocyte associated protein 4, anti-PD-1, and anti-PD-L1) within 4 weeks or five half-lives of the drug, whichever is shorter 15. Prior use of any monoclonal antibody for the purposes of treating cancer within 3 months of the start of Cycle 1\n15. Prior use of any monoclonal antibody for the purposes of treating cancer within 3 months of the start of Cycle 1\n16. Any investigational therapy for the purposes of treating cancer within 28 days prior to the start of Cycle 1\n17. Prior radiotherapy to the mediastinal\u002Fpericardial region. Radiotherapy to non-target lesion sites will be permitted.\n18. Corticosteroid use \\> 50 mg\u002Fday of prednisone or equivalent, for purposes other than lymphoma symptom control 18.1 Participants receiving corticosteroid treatment with ≤ 50 mg\u002Fday of prednisone or equivalent for reasons other than lymphoma symptom control (e.g., rheumatoid arthritis) must be documented to be on a stable dose of at least 4 weeks duration prior to the start of cycle 18.2 Corticosteroid therapy for control of cancer symptoms or side effects of prior treatment (e.g., nausea or B-symptoms) is permitted.\n\n    18.3 The use of inhaled corticosteroids is permitted. 18.4 The use of mineralocorticoids for management of orthostatic hypotension is permitted.\n\n    18.5 The use of physiologic doses of corticosteroids for management of adrenal insufficiency is permitted.\n19. Participants who require lymphoma symptom control during screening may receive steroids in the following manner: - Up to 100 mg of prednisone PO (or equivalent steroids) per day for up to 7 days are allowed. Prednisone dose is at the discretion of the treating physician, provided that the dose is within the above specified dosage range. - As part of the pre-phase treatment, vincristine or rituximab may not be administered.\n20. History of other malignancy that could affect compliance with the protocol or interpretation of results:\n\n    20.1 Participants with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix at any time prior to the study are eligible.\n\n    20.2 Participants with any malignancy appropriately treated with curative intent and the malignancy has been in remission without treatment for ≥ 2 years prior to enrollment are eligible.\n\n    20.3 Participants with low-grade, early-stage prostate cancer (Gleason score 6 or below, Stage 1 or 2) with no requirement for therapy at any time prior to study are eligible.\n\n    20.4 Patients with other concomitant malignancies may be eligible after discussion with, and confirmation by the PI\n21. Live, attenuated vaccine within 4 weeks before study treatment infusion on Day 1 of Cycle 1 or anticipation that such a live, attenuated vaccine will be required during the study. Live vaccines during the study and until participants B cells recover, are prohibited.\n\n21.1 Influenza vaccination should be given during influenza season only. Participants must not receive live, attenuated influenza vaccine at any time during the study treatment period.","65 Years","80 Years",{"count":92,"type":20},42,[24],"The researchers are doing this study to find out if the study treatment is an effective treatment that causes few or mild side effects in people with diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBCL), or transformed lymphoma. The treatment being tested in this study is glofitamab, polatuzumab, and obinutuzumab in combination with standard treatment (the combination of rituximab, cyclophosphamide, doxorubicin, and prednisone, or R-miniCHP).",[96,97],"Diffuse Large B Cell Lymphoma (DLBCL)","High Grade B Cell Lymphoma",[99,100,101,102,103,104],"Glofitamab","Polatuzumab","Obinutuzumab","Rituximab","Cyclophosphamide","Doxorubicin","2026-06-04",{"date":107,"type":46},"2026-06-05",{"date":109,"type":46},"2025-01-16",{"date":111,"type":20},"2028-01",{"name":113,"class":114},"Memorial Sloan Kettering Cancer Center","OTHER",{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":21,"phases":124,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":140},"100551311","phase-2-epcoritamab-car-t-cells-for-large-b-cell-lymphomas-100551311","NCT06458439","Epcoritamab-CAR T Cells for Large B-cell Lymphomas","Phase IIa Trial to Evaluate Epcoritamab Administered Before and After CAR-T Cell Therapy in Patients With Relapsed or Refractory Large B-cell Lymphomas","Inclusion Criteria:\n\n* Age \\> 18 years\n* Subject must be able and willing to provide informed consent. In the case where the patient is incapacitated or not otherwise capable, a legally authorized representative (or decision maker when there is not an advanced directive in place) must be willing to provide informed consent on behalf of the patient.\n* Able to comply with the study protocol, in the investigator's judgment\n* ECOG PS of 0 - 2\n* Pathology report confirming eligible diagnosis\n* Documented CD20+ tumor cells on most recent biopsy\n* Patients will have failed to respond to frontline standard of care therapy containing an anthracycline and anti-CD20 antibody\n* Patients will be eligible and consent to be treated with a \"commercially available\" anti-CD19, 4-1BB, CD3zeta CAR-T cell therapy or anti-CD19, CD28, CD3zeta CAR T cell therapy (for example, tisagenlecleucel, lisocabtagene maraleucel, or axicabtagene maraleucel)\n* Patients must have a PET\u002FCT scan (preferred), diagnostic CT scan, or MRI with at least one bi-dimensionally measurable lesion (≥ 1.5 cm for nodal lesions or ≥ 1cm for extra-nodal lesions in largest dimension by low-dose computerized tomography \\[CT\\] scan with FDG-uptake ≥ liver)\n* Adequate laboratory studies\n* Resolution of toxicities from prior therapy to a grade that does not contraindicate trial participation in the opinion of the investigator\n* Ability and willingness to take proper contraceptive precautions\n\nExclusion Criteria:\n\n* Inability or unwillingness of the patient or legally authorized representative (or decision-maker when there is not an advanced directive in place) to provide informed consent.\n* Prior solid organ transplantation\n* Primary central nervous system (CNS) lymphoma or active secondary CNS involvement by lymphoma at screening as confirmed by magnetic resonance imaging (MRI)\u002Fcomputed tomography (CT) scan (brain) or, if clinically indicated, by lumbar puncture.\n* History of autoimmune disease or other diseases resulting in permanent immunosuppression or requiring chronic immunosuppressive therapy (see Exclusion Criteria 5a), with the following exceptions:\n\n  1. Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone\n  2. Patients with a history of lymphoma-related immune thrombocytopenic purpura or autoimmune hemolytic anemia in remission may be eligible for this study if approved by the Regulatory Sponsor and Principal Investigator\n  3. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n  i. Rash must cover \\\u003C 10% of body surface area ii. Disease is well controlled at baseline and requires only low-potency topical corticosteroid iii. No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or corticosteroids (\\> 20 mg\u002Fday prednisone or equivalent for \\> 2 weeks) within the previous 3 months d. rheumatoid arthritis or similar autoimmune\u002Frheumatic conditions\n* Systemic immunosuppressive medications (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents). However, the following are permitted:\n\n  1. If receiving glucocorticoid treatment at screening, must be a maximum daily dose of prednisone 10 mg (or equivalent) and a total of no more than 140 mg over the last 14 days prior to the first dose of epcoritamab, unless for disease control.\n  2. Patients who received a single dose of a systemic immunosuppressant medications (e.g., single dose of dexamethasone for nausea or B symptoms) may be enrolled\n  3. The use of inhaled corticosteroids is permitted\n  4. The use of mineralocorticoids for management of orthostatic hypotension is permitted\n  5. The use of physiologic doses of corticosteroids (\\\u003C 20 mg\u002Fday of prednisone or equivalent) for uses such as management of adrenal insufficiency is permitted\n* Known past or current malignancy, other than inclusion diagnoses, except for:\n\n  1. Cervical carcinoma of Stage 1B or less.\n  2. Adequately resected, non-metastatic basal cell or squamous cell skin carcinoma.\n  3. Non-invasive, superficial bladder cancer.\n  4. Prostate cancer with a current PSA level \\\u003C0.1 ng\u002FmL.\n  5. Patients with a malignancy that has been treated with curative intent will also be enrolled if that malignancy is in remission prior to first dose of epcoritamab\n* Known clinically significant cardiovascular disease\n* Patients with the following active infection(s) could have increased risks for toxicity if treated with bispecific antibody therapy, thus patient will be excluded if:\n\n  1. Positive serologic or PCR test results for acute or chronic HBV infection. Patients whose HBV infection status cannot be determined by serologic test results (www.cdc.gov\u002Fhepatitis\u002Fhbv\u002Fpdfs\u002Fserologicchartv8.pdf) must be negative for HBV by PCR to be eligible for study participation. Patients with a history of hepatitis B who are negative for HBV by PCR, will not be excluded but will be placed on suppressive antiviral therapy\n  2. Acute or chronic HCV infection. Patients who are positive for HCV antibody must be negative for HCV by PCR to be eligible for study participation. Patients with a history of hepatitis C who have been adequately treated (negative PCR) will not be excluded.\n  3. Positive serologic or RT-PCR test results for HIV infection.\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major documented infection requiring treatment with IV antibiotics or hospitalization within 2 weeks of enrollment. Empiric or prophylactic antibiotics administered during neutropenia or neutropenic fever without microbiologic evidence of infection do not exclude patients.\n* Clinically significant pulmonary disease (e.g., bronchospasm and\u002For obstructive pulmonary disease) that requires chronic oxygen or corticosteroid use \\> 20 mg mg\u002Fday prednisone or equivalent\n* Uncontrolled seizure disorder\n* Exposure to live or live attenuated vaccine within 4 weeks prior to signing ICF\n* Pregnancy or breast feeding\n* Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results",{"count":123,"type":20},31,[24],"This study investigates the feasibility and efficacy of epcoritamab treatment before CAR T cells. This study also investigates if, when patients have residual lymphoma after CAR T cells, epcoritamab can help to effectively treat that lymphoma.",[127,128,129,31,130],"Lymphoma, Non-Hodgkin","Relapsed Diffuse Large B Cell Lymphoma","Refractory Diffuse Large B-cell Lymphoma","Transformed Indolent Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma","2026-05-22",{"date":133,"type":46},"2026-05-27",{"date":135,"type":46},"2024-09-24",{"date":137,"type":20},"2027-12",{"name":139,"class":114},"Abramson Cancer Center at Penn Medicine",1,{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":148,"enrollmentInfo":149,"targetDuration":4,"studyType":21,"phases":150,"briefSummary":151,"conditions":152,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":140},"100535235","phase-1-mosunetuzumab-with-chemotherapy-for-the-treatment-of-patients-with-untreated-c-myc-rearrangement-positive-high-grade-b-cell-lymphoma-or-diffuse-large-b-cell-lymphoma-100535235","NCT06249191","Mosunetuzumab With Chemotherapy for the Treatment of Patients With Untreated C-Myc Rearrangement Positive High Grade B Cell Lymphoma or Diffuse Large B Cell Lymphoma","A Phase Ib\u002FII Study Evaluating the Safety and Efficacy of Mosunetuzumab in Combination With DA EPOCH in Previously Untreated C-Myc Rearrangement Positive High-Grade B Cell Lymphomas","Inclusion Criteria:\n\n* For both phases of the study, participant must be 18-75 years of age and have previously untreated high-grade B cell lymphoma (HGBCL) or diffuse large B cell lymphoma (DLBCL), including transformed DLBCL per the World Health Organization (WHO) 2022 classification, and with documented c-Myc rearrangement on fluorescence in situ hybridization (FISH) testing. Eligible types of c-Myc rearrangements will be performed by FISH testing and may include any single MYC rearrangement (single-hit lymphoma), Double hit (DHL) lymphoma or and triple hit (THL) lymphoma defined by translocations of MYC and BCL2 (DHL) and BCL6 (THL)\n* Pathology must be verified and confirmed by university pathologists at the enrolling institution and centrally (OHSU) for any biopsies read outside of either institution\n* Stage II or higher and International Prognostic Index (IPI) score of 2-5\n* Able to comply with the study protocol and procedures, in the investigator's judgment\n* At least one bi-dimensionally measurable nodal lesion, defined as ≥ 1.5 cm in its longest dimension, or one bi-dimensionally measurable extranodal lesion, defined as ≥ 1.0 cm in its longest diameter\n* Confirmed availability of archival or freshly collected tumor tissue before study enrollment\n* Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2\n* Left ventricular ejection fraction (LVEF) defined by multiple-gated acquisition (MUGA) scan or echocardiogram (ECHO) within the institutional limits of normal\n* Absolute neutrophil count (ANC) ≥ 1.0 ×10\\^9\u002FL (14 days prior to first mosunetuzumab dose) (unless inadequate function is due to underlying disease, as established by extensive bone marrow involvement, or is due to hypersplenism secondary to the involvement of the spleen by lymphoma per the investigator) without transfusion\n* Platelet count ≥ 75 ×10\\^9\u002FL (14 days prior to first mosunetuzumab dose) (unless inadequate function is due to underlying disease, as established by extensive bone marrow involvement, or is due to hypersplenism secondary to the involvement of the spleen by lymphoma per the investigator) without transfusion\n* Total hemoglobin ≥ 10 g\u002FdL (21 days prior to first mosunetuzumab dose) (unless inadequate function is due to underlying disease, as established by extensive bone marrow involvement, or is due to hypersplenism secondary to the involvement of the spleen by lymphoma per the investigator) without transfusion\n* Serum creatinine ≤ upper limit of normal (ULN); or estimated creatinine clearance ≥ 50 mL\u002Fmin by Cockcroft Gault method or other institutional standard methods, e.g. based on nuclear medicine renal scan\n* For persons of childbearing potential (PCBP), an agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \\\u003C 1% per year, and confirmed agreement to refrain from donating eggs, during the treatment period and for at least 3 months after the last dose of mosunetuzumab, and 3 months after the last dose of tocilizumab (if applicable), whichever is longer\n* For participants who can produce sperm and create pregnancy: confirmed agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm\n\nExclusion Criteria:\n\n* Pregnant or breast \u002Fchestfeeding\n* Prior treatment for DLBCL. Exceptions:\n\n  * Prednisone of ≤ 100 mg for up to 10 days, within 28 days prior to starting study treatment. Prednisone or equivalent corticosteroid must be discontinued by the time of treatment start\n  * One cycle of RCHOP or DA R EPOCH\n* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products\n* Contraindication to receive full dose of any of the individual components of EPOCH\n* Participants with history of confirmed progressive multifocal leukoencephalopathy (PML)\n* Known or suspected chronic active Epstein Barr virus (CAEBV) infection\n* Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen \\[HBsAg\\] serology)\n\n  \\* Participants with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus (HBV) deoxyribonucleic acid (DNA) is undetectable at the time of screening. These Participants must be willing to undergo monthly DNA testing and appropriate antiviral therapy as indicated\n* Acute or chronic hepatitis C virus (HCV) infection. Participants positive for HCV by antibody testing, but negative for HCV by polymerase chain reaction (PCR) are eligible\n* HIV seropositivity\n* Administration of a live, attenuated vaccine within 4 weeks before first study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study\n* Prior solid organ transplantation\n* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH).\n* History of autoimmune disease, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Exceptions:\n\n  * Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible.\n  * Participants with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n  * Participants with a history of disease-related immune thrombocytopenic purpura, autoimmune hemolytic anemia, or other stable autoimmune diseases may be eligible after review and approval by the primary investigator (PI)\n* Systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) with the exception of pre-phase treatment with prednisone up to 100 mg daily for 7 days (or equivalent corticosteroid dose) prior to cycle 1 day 1 (C1D1). Exceptions:\n\n  * The use of inhaled corticosteroids is permitted.\n  * The use of mineralocorticoids for management of orthostatic hypotension is permitted.\n  * The use of physiologic doses of corticosteroids for management of adrenal insufficiency is permitted\n* Current active central nervous system (CNS) involvement of lymphoma on the screening MRI brain\n* Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, neurodegenerative disease. Exceptions:\n\n  * Participants with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 2 years and have no residual neurologic deficits as judged by the investigator are allowed.\n  * Participants with a history of epilepsy who have had no seizures in the past 2 years while not receiving any anti-epileptic medications are allowed in the expansion cohorts only\n* Prior radiotherapy to the mediastinal \u002F pericardial region within 4 weeks\n* Malignancy treated with curative intent unless in documented remission without treatment for 2 years prior to enrollment, or other malignancy that could affect compliance with the protocol or interpretation of results. Exception: Participants with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix are eligible. Adjuvant endocrine therapy for non-metastatic, hormone receptor-positive breast cancer is permitted\n* Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results or that could increase risk to the Participant, including renal disease that would preclude chemotherapy administration or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm)\n* Significant pulmonary disease (including obstructive pulmonary disease and history of bronchospasm)\n* Significant cardiovascular disease, defined as\n\n  * New York Heart Association \\[NYHA\\] Class III or IV cardiac disease,\n  * Congestive heart failure,\n  * Myocardial infarction within the previous 6 months,\n  * Unstable arrhythmias, or\n  * Unstable angina\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks before C1D1\n* Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis\n* Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \\> 2.5 x ULN within 14 days of initiation of study treatment\n* Total bilirubin ≥ 1.5 x ULN within 14 days of initiation of study treatment\n* International normalization ratio (INR) \\> 1.5 x ULN in the absence of therapeutic anticoagulation within 14 days of initiation of study treatment\n* Partial prothrombin time (PTT) or adjusted partial prothrombin time (aPTT) \\> 1.5 x ULN in the absence of a lupus anticoagulant within 14 days of initiation of study treatment\n* Herbal therapies intended as treatment of lymphoma\n* Medicinal or recreational cannabis products are not permitted while receiving the study intervention.","75 Years",{"count":64,"type":20},[23,24],"This phase Ib\u002FII clinical trial tests the safety, side effects, and effectiveness of mosunetuzumab with chemotherapy for the treatment of patients with untreated, c-Myc rearrangement positive, high grade B cell lymphoma or diffuse large B cell lymphoma. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as mosunetuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as etoposide, doxorubicin, vincristine, cyclophosphamide and prednisone work in different ways to stop the growth of cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving mosunetuzumab with chemotherapy may be safe, tolerable and\u002For effective in treating patients with untreated, c-Myc rearrangement positive, high grade B cell lymphoma or diffuse large B cell lymphoma.",[153,69],"Diffuse Large B-Cell Lymphoma","2026-04-22",{"date":156,"type":46},"2026-04-24",{"date":158,"type":46},"2024-06-13",{"date":160,"type":20},"2027-04-01",{"name":162,"class":114},"OHSU Knight Cancer Institute",{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":21,"phases":172,"briefSummary":173,"conditions":174,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":209},"100557911","phase-1-synkir-310-for-relapsedrefractory-b-nhl-100557911","NCT06544265","SynKIR-310 for Relapsed\u002FRefractory B-NHL","A Phase 1 Study of SynKIR-310, Autologous T Cells Transduced With CD19 KIR-CAR, in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n* Adult 18 years of age and older.\n* Histologically confirmed diagnosis of B-NHL before enrollment.\n* Must have received prior CAR T or were unwilling\u002Funable to receive prior CAR T.\n* Must have refractory or relapsed disease after receiving 2 prior lines of therapies.\n* If relapsed\u002Frefractory post-auto-SCT, then must have undergone auto-SCT at least 6 months prior to enrollment.\n* If relapsed\u002Frefractory disease after allogeneic stem cell transplant (allo SCT) then must have undergone allo-SCT at least 6 months prior to enrollment and without evidence of graft versus host disease, and expectation to remain off immunosuppressive therapy through duration of trial\n* Measurable disease at time of enrollment: At least one measurable lesion per Lugano Response Criteria (Cheson et al., 2014) or measurable disease per IWWM-11 response criteria (Treon 2023) for Waldenström macroglobulinemia patients.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1\n\nExclusion Criteria:\n\n* Previously treated with any investigational agent within 30 days prior to screening.\n* Any previous or concurrent malignancy, with the following exceptions:\n\nAdequately treated non-melanoma skin cancer such as basal cell or squamous cell carcinoma; carcinoma-in-situ (e.g., cervix, bladder, breast) treated curatively and without evidence of recurrence for at least 3 years prior to enrollment or adequately treated melanoma skin cancer in-situ; any other malignancy which has been completely treated and remains in complete remission for ≥ 5 years prior to enrollment. Completely treated prostate cancer with prostate-specific antigen (PSA) level \\\u003C 1.0 may also be permitted.\n\n* Use of systemic immunosuppressive drugs within 4 weeks prior to study entry, or anticipated use of systemic immunosuppressive agents through end of study, with the exception of non-T cell targeting agents prior to leukapheresis\n* Known immunodeficiency disease , with the exception of hypoglobulinemia\n* History or presence of active or clinically relevant primary central nervous system (CNS) disorder, such as seizure, encephalopathy, cerebrovascular ischemia\u002Fhemorrhage, cerebellar disease, or any autoimmune disease with CNS involvement. For primary CNS disorders that have recovered or are in remission, participants without recurrence within 2 years of planned study enrollment may be included.\n* Uncontrolled hypertension, history of myocarditis or congestive heart failure, unstable angina, serious uncontrolled cardiac arrhythmia, or myocardial infarction within 6 months prior to study entry.\n* Any active uncontrolled systemic fungal, bacterial or viral infection.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":171,"type":20},36,[23],"This first-in-human (FIH) trial is designed to assess the safety, feasibility and preliminary efficacy of a single intravenous (IV) dose of SynKIR-310 administered to participants with relapsed\u002Frefractory B-NHL.",[175,176,177,178,179,180,181,182,183,184,185,31,186,187,188,189,190,191,192,193,194,195,196,197,198,199],"B Cell Lymphoma","NHL, Adult","Mantle Cell Lymphoma","Relapsed Non-Hodgkin Lymphoma","Refractory Non-Hodgkin Lymphoma","Aggressive B-Cell Non-Hodgkin Lymphoma","Indolent B-Cell Non-Hodgkin Lymphoma","Follicular Lymphoma","Marginal Zone Lymphoma","DLBCL - Diffuse Large B Cell Lymphoma","HGBL With MYC and BCL2 and\u002For BCL6 Rearrangements","Diffuse Large B Cell Lymphoma","Large B-cell Lymphoma","T-Cell\u002FHistiocyte Rich Lymphoma","Non-hodgkin Lymphoma,B Cell","Primary Mediastinal Large B-cell Lymphoma (PMBCL)","Epstein-Barr Virus Positive DLBCL, Nos","Follicular Lymphoma Grade 3B","DLBCL (Diffuse Large B-Cell Lymphoma) Associated With Chronic Inflammation","High Grade B-Cell Lymphoma, Not Otherwise Specified","Follicular Lymphoma Grade 3","Marginal Zone Splenic Lymphoma","DLBCL","Waldenstrom Macroglobulinemia","Waldenstrom Macroglobulinaemia","2026-04-08",{"date":202,"type":46},"2026-04-14",{"date":204,"type":46},"2024-11-01",{"date":206,"type":20},"2028-12",{"name":208,"class":53},"Verismo Therapeutics",5,{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":11,"sex":16,"minAge":217,"maxAge":4,"enrollmentInfo":218,"targetDuration":4,"studyType":220,"phases":4,"briefSummary":221,"conditions":222,"keywords":228,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":140},"100385614","study-of-car-t-therapy-in-older-patients-100385614","NCT04300998","Study of CAR-T Therapy in Older Patients","Observational Study of Commercial Chimeric Antigen Receptor T-cell (CAR T) Therapy in Older Patients With Hematologic Malignancies and With an Embedded Pilot Study of Longitudinal Geriatric and Neurocognitive Evaluation","Inclusion Criteria:\n\n* are ≥60 years old (all cohorts)\n* have pathologically confirmed, relapsed refractory lymphoid malignancy or plasma cell disorder receiving a commercial CAR T-cell product (all cohorts)\n* able to speak and understand English (cohort 1 and 4 only)\n* have a MoCA score of less than 26 out of 30 during the GA visit by a geriatrician prior to CAR T-cell treatment (cohort 4 only)\n\nExclusion Criteria:\n\n* Any prior commercial or investigational CAR T therapy (all cohorts)\n* Current diagnosis of major Axis I psychiatric disorder (DSM-IV), major depression, bipolar disorder, or schizophrenia, as per medical records or patient report (cohort 1 only)\n* History of a neurological disorder, neurodegenerative disease, or traumatic brain injury with loss of consciousness (\\>60 minutes), as per medical records or patient report (cohort 1 only)\n* Current ongoing substance abuse and\u002For history of substance abuse, as per medical records or patient report (cohort 1 only)\n* History of CNS disease (cohort 4 only)","60 Years",{"count":219,"type":20},154,"OBSERVATIONAL","This study is being done to find out how older patients respond to CAR-T cell therapy and how the treatment affects their quality of life. This is a quality of life study and participating in the study does not involve receiving any treatment, other than the standard treatment for participants' disease.",[223,224,225,226,31,227],"Lymphoma","Refractory B-Cell Lymphoma","Lymphoma, B-Cell","DLBCL NOS","Multiple Myeloma",[223,229,230,31,226,224,231,113],"CART therapy","relapsed refractory large B-cell lymphoma","19-452","2026-04-01",{"date":234,"type":46},"2026-04-07",{"date":236,"type":46},"2020-03-04",{"date":238,"type":20},"2027-03-04",{"name":113,"class":114},{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":11,"sex":16,"minAge":247,"maxAge":4,"enrollmentInfo":248,"targetDuration":4,"studyType":21,"phases":250,"briefSummary":251,"conditions":252,"keywords":257,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":272},"100532125","phase-1-clic-2201-for-the-treatment-of-relapsedrefractory-b-cell-malignancies-100532125","NCT06208735","CLIC-2201 for the Treatment of Relapsed\u002FRefractory B Cell Malignancies","CLIC-02: A Phase I Trial of CLIC-2201 for the Treatment of Relapsed\u002FRefractory B Cell Malignancies","Inclusion Criteria in Cohort A:\n\nParticipants must meet the following criteria to be enrolled on the trial:\n\n1. Participants in the cohort A must be 18 years of age or older of age at time of informed consent.\n2. Participants must provide written informed consent.\n3. Participants must have a relapsed or refractory B cell lymphoma, including one of the following:\n\n   1. diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS),\n   2. high grade B cell lymphoma NOS,\n   3. high grade B cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements,\n   4. primary mediastinal large B-cell lymphoma (PMBCL),\n   5. aggressive B cell lymphoma transformed from an indolent lymphoma,\n   6. mantle cell lymphoma (MCL),\n4. Participants must have refractory or relapsed disease, defined as one of the following:\n\n   1. Relapse or refractory disease after at least 2 lines of therapy, OR\n   2. Any relapse after autologous or allogeneic hematopoietic cell transplantation (HCT), OR\n   3. Any relapse after CAR-T cell therapy.\n5. Participants must have adequate organ function at enrolment, defined as:\n\n   1. Left ventricular ejection fraction (LVEF) ≥40%,\n   2. Creatinine clearance using Cockcroft-Gault of \\> 30 mL\u002Fmin, AND\n   3. ALP\u002FALT \\\u003C 5X upper limit of normal (ULN), conjugated bilirubin \\\u003C 2X ULN, and no evidence or history of liver cirrhosis.\n6. Participants must have Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 or Karnofsky Score ≥50%.\n7. Females of child-bearing potential and sexually active males must agree to use a highly effective contraception method (see section 5.4) through to at least one year following administration of the CLIC-2201 product.\n8. Participants with accessible disease, must be willing to undergo a tumour biopsy at enrolment. For participants with a recent (within 3 months) tumor biopsy, access to the archival biopsy is acceptable.\n\nInclusion Criteria in Cohort B:\n\n1. Participants in the cohort B must be between 1-39 years of age at the time of consent.\n2. For participants who are under the age of consent as defined by REB requirements, parent or legal guardian of the participant must provide the informed consent and the participant's assent\u002Fconsent must be obtained (if applicable).\n3. Participants must have a relapsed or refractory B cell acute lymphoblastic leukemia (B-ALL).\n4. Participants must have refractory or relapsed disease, defined as one of the following:\n\n   1. Relapse or refractory disease after at least 2 lines of therapy, OR\n   2. Any relapse after autologous or allogeneic hematopoietic cell transplantation (HCT), OR\n   3. Any relapse after CAR-T cell therapy.\n5. Participants in cohort B and\u002For those who have received CD22 targeted therapy must have documentation of CD22 tumour expression within the 6 months prior to study screening, and after any prior CD22 directed therapy (if applicable).\n6. Participants must have adequate organ function at enrolment, defined as:\n\n   1. Left ventricular ejection fraction (LVEF) ≥45%,\n   2. Creatinine clearance using Cockcroft-Gault or Schwartz equation of \\> 30 mL\u002Fmin, AND\n   3. ALP\u002FALT \\\u003C 5X upper limit of normal (ULN), conjugated bilirubin \\\u003C 2X ULN, and no evidence or history of liver cirrhosis.\n7. Participants must have a Karnofsky or Lansky Score ≥50%.\n8. Participants of reproductive age must agree to use a highly effective contraception method (see section 5.4) through to at least one year following administration of the CLIC-2201 product.\n9. Participants must be willing to undergo a bone marrow biopsy at enrolment.\n\nExclusion Criteria:\n\n1. Any uncontrolled or serious active infection at the time of enrolment.\n2. Active autoimmune disease requiring immunosuppressive therapy within 4 weeks of enrolment.\n3. Live vaccine ≤6 weeks prior to enrolment\n4. Active Graft Versus Host Disease (GVHD) requiring systemic immunosuppressive therapy within 4 weeks of enrolment.\n5. Diagnosis of primary central nervous system lymphoma (PCNSL)\n6. Treatment with any of the following in the specified time period before leukapheresis:\n\n   1. Allogeneic HCT within 3 months,\n   2. Autologous HCT within 3 months,\n   3. CD19 CAR-T cell infusion within 3 months,\n   4. Donor lymphocyte infusion (DLI) within 3 months,\n   5. Bendamustine within the last 6 months,\n   6. Any investigational agent within 30 days or 5 half-lives (whichever is shorter),\n   7. Systemic administration of therapeutic dose corticosteroids (\\>20 mg\u002Fday prednisone or equivalent for adults and ≥ 12 mg\u002Fm2\u002Fday for paediatric participants) within 7 days prior to leukapheresis.\n   8. Immunosuppressive therapies (i.e., calcineurin inhibitors, methotrexate, mycophenolate, rapamycin) within 4 weeks, unless used as treatment for the B cell malignancy.\n   9. Oral chemotherapy agents (i.e., venetoclax) within 5 half-lives. An exception to this is that bruton tyrosine kinase (BTK) inhibitors like ibrutinib can be continued in participants with mantle cell lymphoma throughout the trial period.\n7. Other concurrent malignancy or a prior malignancy treated within the past 2 years, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease.\n8. Concomitant genetic syndrome associated with bone marrow failure such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure or immunodeficiency syndrome.\n9. Active (confirmed by PCR) hepatitis B or hepatitis C at time of screening confirmed by PCR.\n10. Any Human Immunodeficiency Virus (HIV) infection at time of screening.\n11. Hypersensitivity to fludarabine or cyclophosphamide.\n12. Any allergy to gentamycin or its derivatives\n13. Participants who do not meet the minimum weight requirement for the planned dose level.\n14. Pregnant or nursing participants.","1 Year",{"count":249,"type":20},24,[23],"This is a phase I dose-finding trial of an autologous CD22 targeting chimeric antigen receptor (CAR)-T cell product, called CLIC-2201, for participants with relapsed\u002Frefractory B cell malignancies. In the proposed trial, eligible enrolled participants will undergo leukapheresis for autologous T cell collection to enable CLIC-2201 manufacturing, followed by lymphodepletion with cyclophosphamide and fludarabine, then intravenous infusion of the autologous CLIC-2201 product. The trial will use the 3+3 design to escalate or de-escalate the dose level of CLIC-2201 administered. Participants will be monitored for safety and tolerability up to day 365 following CLIC-2201 infusion.\n\nThe primary objective is to evaluate the safety and tolerability of CLIC-2201 and estimate the maximum tolerated dose (MTD) of CLIC-2201 in B-cell malignancies.\n\nThe secondary objectives are to evaluate the (i) feasibility; (ii) anti-tumour activity of CLIC-2201; (iii) and characterize the pharmacokinetic (PK) profile of CLIC-2201.\n\nExploratory objectives will include: i) characterizing the cellular and humoral immune responses against CLIC-2201 up to 1 year following infusion of CLIC-2201; (ii) characterizing the phenotype and gene expression profile of CLIC-2201 cells; (iii) evaluating immune and tumour cells at baseline and relapse for biomarkers of response or toxicity; (iv) evaluating serum cytokines, circulating tumour DNA (ctDNA) and B cell aplasia as biomarkers of clinical outcomes; and (v) assessing the quality of life.",[253,254,255,186,31,190,177,256],"B-Cell Leukemia","Non-Hodgkin's Lymphoma","B-cell Acute Lymphoblastic Leukemia","B-cell Lymphoma",[258,259,260,261,262],"Chimeric Antigen Receptor T cells","CLIC-2201","CD22","Immunotherapy","CAR-T cell","2026-03-30",{"date":265,"type":46},"2026-04-03",{"date":267,"type":46},"2025-01-02",{"date":269,"type":20},"2027-08-01",{"name":271,"class":114},"British Columbia Cancer Agency",7,{"id":274,"slug":275,"hasResults":11,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":279,"eligibilityCriteria":280,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":4,"enrollmentInfo":281,"targetDuration":4,"studyType":21,"phases":282,"briefSummary":283,"conditions":284,"keywords":285,"overallStatus":290,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":292,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":140},"100631606","phase-2-tpg-tafasitamab-polatuzumab-vedotin-and-glofitamab-as-first-line-therapy-for-diffuse-large-b-cell-lymphoma-and-high-grade-b-cell-lymphoma-100631606","NCT07502872","TPG: Tafasitamab, Polatuzumab Vedotin, and Glofitamab as First-line Therapy for Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma","TPG: a Phase 2 Trial of Polatuzumab Vedotin, Glofitamab, and Tafasitamab as Chemotherapy-sparing First-line Therapy for Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma","TPG","Inclusion Criteria:\n\n1. Ability to understand and the willingness to sign a written informed consent document and to comply with the study protocol procedures.\n2. Age ≥18 years.\n3. Histologically confirmed diagnosis of DLBCL, or HGBL, according to 5th edition WHO classification. Eligible WHO entities include:\n\n   * Diffuse large B-cell lymphoma, not otherwise specified (NOS)\n   * T-cell\u002Fhistiocyte-rich large B-cell lymphoma\n   * DLBCL\u002FHGBL with MYC and BCL2 rearrangements\n   * Large B-cell lymphoma with IRF4 rearrangement\n   * HGBL with 11q aberration\n   * EBV-positive diffuse large B-cell lymphoma\n   * DLBCL associated with chronic inflammation\n   * Primary large B-cell lymphoma of immune-privileged sites\n   * Primary cutaneous DLBCL, leg type\n   * Intravascular large B-cell lymphoma\n   * Primary mediastinal large B-cell lymphoma\n   * HGBL, NOS\n   * Grade 3B follicular lymphoma.\n4. FDG-avid disease by PET-CT Lugano criteria.\n5. No prior systemic therapy for B-cell lymphoma, except for:\n\n   * corticosteroids;\n   * a single cycle of chemotherapy administered prior to enrollment (to facilitate enrolling patients who require emergent initiation of therapy for rapidly progressive or symptomatic lymphoma);\n   * prior local radiation therapy;\n   * prior treatment for indolent lymphoma.\n6. Performance status ECOG 0, 1, or 2.\n7. Ability to receive one of the standard chemotherapy regimens for DLBCL\u002FHGBL including attenuated versions, where clinically appropriate\n8. Required initial laboratory values: (unless due to underlying lymphoma):\n\n   * absolute neutrophil count ≥1.0 x 109\u002FL,\n   * platelet count ≥75 x 109\u002FL.\n   * creatinine ≤ 1.5 mg\u002FdL or glomerular filtration rate (GFR) ≥40 mL\u002Fmin\u002F1.73m2 using the Mayo Quadratic Formula\n   * total bilirubin ≤ 1.5 × institution upper limit of normal (ULN) unless attributable to Gilbert's disease\n   * AST and ALT ≤ 3 × institution ULN.\n   * Negative antigen or PCR test for SARS-CoV-2.\n9. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) and refrain from donating eggs or sperm throughout the treatment and for 3 months after the last dose of trial therapy.\n\nExclusion Criteria:\n\n1. Pregnancy, breast-feeding, or prisoner status.\n2. Central nervous system involvement by the lymphoma.\n3. Prior solid organ transplantation or allogeneic stem cell transplantation.\n4. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products.\n5. Known NYHA class 3\u002F4 congestive heart failure, left ventricular ejection fraction (LVEF) \\\u003C30%, or active ischemic heart disease.\n6. Chronic obstructive pulmonary disease (COPD) requiring continuous oral corticosteroids or chronic oxygen.\n7. Grade \\>1 peripheral neuropathy.\n8. Use of systemic immunosuppressive medications (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents), within 2 weeks prior to first dose of study treatment (except as allowed in the inclusion criteria for the management of lymphoma).\n9. Any of the following conditions:\n\n   * active bacterial infection requiring antibiotics\n   * chronic active Epstein Barr virus (CAEBV) infection\n   * history of hemophagocytic lymphohistiocytosis (HLH)\n   * history of Stevens-Johnson syndrome or toxic epidermal necrolysis\n   * progressive multifocal leukoencephalopathy (PML)\n   * known active EBV or CMV viremia\n   * autoimmune disease requiring systemic immunosuppressive therapy\n   * active myasthenia gravis, myositis, autoimmune hepatitis, idiopathic pulmonary fibrosis, systemic lupus erythematosus, inflammatory bowel disease, granulomatosis with polyangiitis, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis\n   * active hepatitis B (HBV) or hepatitis C (HCV) infection. Patients with a positive total\u002FIgG HBV core antibody (HBcAb) are eligible if (1) HBV DNA is documented at screening, (2) they agree to take entecavir or tenofovir, and (3) they agree to undergo periodic DNA testing. Patients with a positive HCV antibody are eligible if a negative polymerase chain reaction (PCR) for HCV is documented.\n   * HIV infection with a detectable viral load or a CD4 count \\\u003C200 cells\u002Fmm3. Patients (1) with an undetectable viral load and CD4 count \\>200 cells\u002Fmm3 within 6 months prior to enrollment, and (2) on antiretroviral therapy are eligible.\n10. Administration of a live, attenuated vaccine within 4 weeks before first treatment or anticipation that such a live, attenuated vaccine will be required during the study.\n11. History of other malignancy that could affect compliance with the protocol or interpretation of the primary endpoint in the judgement of the investigator.\n12. Any major surgery within 4 weeks before the first dose of treatment.\n13. Evidence of other significant or uncontrolled medical or psychiatric conditions that could affect compliance with the protocol, in the judgement of the investigator.",{"count":64,"type":20},[24],"This is a single-center, phase 2, open-label clinical trial of a novel combination of polatuzumab vedotin, glofitamab, and tafasitamab (TPG) as first-line treatment of patients with diffuse large B cell lymphoma (DLBCL) or high-grade B cell lymphoma (HGBL).",[186,31,223,225],[286,287,288,289],"glofitamab","polatuzumab vedotin","tafasitamab","immunotherapy","NOT_YET_RECRUITING","2026-03-25",{"date":293,"type":46},"2026-03-31",{"date":295,"type":20},"2026-05-01",{"date":297,"type":20},"2029-12-01",{"name":299,"class":114},"Brown University",{"id":301,"slug":302,"hasResults":11,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":4,"eligibilityCriteria":306,"healthyVolunteers":11,"sex":16,"minAge":307,"maxAge":308,"enrollmentInfo":309,"targetDuration":4,"studyType":21,"phases":311,"briefSummary":312,"conditions":313,"keywords":319,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":330},"100557089","phase-1-gene-therapy-for-cd19-positive-hematologic-malignancies-sentry-cd19-100557089","NCT06533579","Gene Therapy for CD19-Positive Hematologic Malignancies (SENTRY-CD19)","A Phase 1\u002F2 Safety, Dose-finding, and Pharmacokinetics Study of VNX-101 Gene Therapy in Patients With Relapsed or Refractory CD19-Positive Hematologic Malignancies (SENTRY-CD19)","Inclusion Criteria:\n\n* Age: Part 1: 18-90 years of age, Part 2: 13-90 years of age\n* Relapsed or refractory CD-19 positive leukemia or lymphoma as defined in the protocol\n* CD19-positive expression\n* AAV specified capsid total antibody \\\u003C1:400\n* Protocol-specified ranges for renal, liver, cardiac and pulmonary function\n* Protocol-specified ranges for hematology parameters\n\nExclusion Criteria:\n\n* Hepatoxicity (AST or ALT \\> 2x upper limit of normal)\n* History of thrombotic microangiopathy or cardiomyopathy, or evidence of sensory neuropathy\n* Pregnant or nursing (lactating) women\n* Acute Graft versus Host Disease (GvHD): Grade 2-4 or chronic GvHD of any grade\n* History of hypersensitivity to corticosteroids or history of corticosteroid-related toxicity\n* Chemotherapy given within the protocol-specified discontinuation timelines\n\nOther Inclusion\u002FExclusion criteria to be applied per protocol.","13 Years","90 Years",{"count":310,"type":20},32,[23,24],"This is a Phase 1\u002F2, first-in-human, open-label, dose-escalating trial designed to assess the safety and efficacy of VNX-101 in patients with relapsed or refractory CD19-positive hematologic malignancies.",[255,187,314,315,183,182,177,186,31,316,190,317,318],"Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","Burkitt Lymphoma","Non Hodgkin Lymphoma","Mixed Phenotype Acute Leukemia",[320,321,223],"CD19-positive","Leukemia","2026-03-24",{"date":263,"type":46},{"date":325,"type":46},"2025-05-30",{"date":327,"type":20},"2031-09",{"name":329,"class":53},"Vironexis Biotherapeutics Inc.",9,{"id":332,"slug":333,"hasResults":11,"nctId":334,"briefTitle":335,"officialTitle":336,"acronym":4,"eligibilityCriteria":337,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":4,"enrollmentInfo":338,"targetDuration":4,"studyType":21,"phases":339,"briefSummary":340,"conditions":341,"keywords":344,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":140},"100518113","phase-1-cd79b-19-car-t-cells-in-non-hodgkin-lymphoma-100518113","NCT06026319","CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma","A Phase I Study of Bivalent CD79b and CD19 Directed CAR T Cells in Patients With Relapsed\u002FRefractory Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n* Voluntarily sign informed consent form(s)\n* ≥18 years of age at the time of signing informed consent\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky ≥60%, see Appendix A)\n* Diagnosis of histologically or cytologically confirmed relapsed\u002Frefractory (R\u002FR) Non Hodgkins lymphoma as defined as one of the following (Note: only patients with indolent lymphomas that warrant treatment should be treated, this will include those with local symptoms due to progressive\u002Fbulky disease, compromised organ function, B symptoms, extra-nodal disease, cytopenias from marrow involvement and\u002For in the opinion of the treating physician believe that any of the above symptoms or potentially life threatening involvement will occur will be treated):\n\n  1. Follicular Lymphoma (FL) grade 1, grade 2, or grade 3a\n\n     1\\. R\u002FR disease after 2 or more prior lines of systemic therapy\n  2. Marginal Zone Lymphoma (MZL) nodal of extranodal:\n\n     1\\. R\u002FR disease after 2 or more prior lines of systemic therapy\n  3. Diffuse large B-cell lymphoma (DLBCL), including transformed follicular lymphoma (FL), primary mediastinal B-cell lymphoma (PMBCL), high-grade B-cell lymphoma (HGBCL) and grade 3b Follicular Lymphoma (FL).\n\n     1. R\u002FR disease after 2 or more prior lines of therapy OR\n     2. Relapsed following autologous SCT, OR\n     3. Ineligible for autologous SCT.\n  4. Mantle cell lymphoma\n\n     1. R\u002FR disease as defined by disease progression after last regimen (including autologous SCT) OR\n     2. Refractory disease as defined as failure to achieve a CR to last regimen.\n     3. Prior therapy must include:\n\n        * Anthracycline or bendamustine-containing chemotherapy AND\n        * Anti-CD20 monoclonal antibody therapy AND\n        * BTKi therapy (progression does not have to be documented on BTKi).\n* Subjects must have measurable disease according to appropriate disease specific criteria.\n* Adequate absolute lymphocyte count (ALC \\> 100 cells\u002Ful) within one week of apheresis.\n* Adequate bone marrow function defined by absolute neutrophil count (ANC) \\>1000 cells\u002Fmm3 without growth factor support (filgrastim within 7 days or pegfilgrastim within 14 days) and untransfused platelet count \\>50,000 mm3.\n* Left ventricular ejection fraction \\> 40%\n* Adequate hepatic function defined by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 2.5 × upper limit of normal (ULN) and direct bilirubin \\\u003C 1.5 × ULN.\n* Adequate renal function defined by creatinine clearance \\>60 ml\u002Fmin using the Cockcroft-Gault formula.\n* The effects of CD79b-19 CAR T cells on the developing human fetus are unknown. For this reason, women of child-bearing potential and men with partners of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to leukapheresis. Women of childbearing potential are required to use adequate contraception for up to 1 year post CD79b-19 CAR T cell infusion. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men with partners of childbearing potential treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and until 6 months after last CD79b-19 CAR T cells administration.\n* Ability and willingness to adhere to the study visit schedule and all protocol requirements\n\nInclusion Criteria for treatment (Initiating Lymphodepletion\u002FCell Infusion):\n\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Karnofsky ≥60%, see Appendix A)\n* No active, uncontrolled, systemic bacterial, viral, or fungal infection. If febrile, the patient must have negative blood cultures x48 hours at time of cell infusion AND on appropriate broad spectrum antibiotic therapy\n* Oxygen saturation \\>92% on room air while awake\n* No additional anti-cancer therapy since leukapheresis excluding steroids at or below physiologic dosing.\n\nInfusion may be delayed by up to 5 days after completion of LD chemo, without sponsor approval, in the event that these issues resolve in that time frame.\n\nThe above criteria need to be met to start treatment (for both initiation of lymphodepletion and cell infusion).\n\nExclusion Criteria for Leukapheresis for Parts A and B:\n\n* Treatment with an any investigational cellular therapy within 8 weeks prior to apheresis.\n* Any systemic anti-cancer therapy within 1 weeks or 5 half-lives of leukapheresis, whichever is shortest, excluding steroids (prednisone) at or below physiologic dosing (5mg).\n* No bispecific T cell engagers within 6 months of leukapheresis.\n* No bendamustime within 6 months of leukapheresis.\n* Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine or systemic steroids above physiologic dosing). Intermittent topical, inhaled, or intranasal corticosteroids are allowed.\n* Ongoing systemic immunosuppression for acute and\u002For chronic GVH as a result of previous allogeneic bone marrow transplant and at least 12 weeks out from prior allogeneic SCT.\n* Presence of active CNS disease\n* Significant co-morbid condition or disease which in the judgment of the Principal Investigator would place the subject at undue risk or interfere with the study; examples include, but are not limited to, cirrhotic liver disease, sepsis, and\u002For recent significant traumatic injury.\n* Active, uncontrolled, systemic bacterial, viral, or fungal infection.\n* Subjects with a history of class III or IV congestive heart failure or with a history of non- ischemic cardiomyopathy.\n* Subjects with unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the previous 3 months.\n* Subjects with arterial vascular disease such as history of cerebrovascular accident or peripheral vascular disease requiring therapeutic anti-coagulation.\n* Subjects with history of a new pulmonary embolism (PE) \u002Fdeep vein thrombosis (DVT) within 6 months of beginning lymphodepletion requiring ongoing anticoagulation.\n* Subjects with second malignancies if the second malignancy has required therapy in the last 3 years or is not in complete remission; exceptions to this criterion include successfully treated non-metastatic basal cell or squamous cell skin carcinoma, or prostate cancer that does not require therapy other than hormonal therapy.\n* Pregnant or lactating women. Pregnant women are excluded from this study because CAR-79b-19 T cell drug product is an agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CAR-79b-19 T cell drug product, breastfeeding should be discontinued if the mother is treated with CAR-79b-19 T cell drug product.\n\nAdditional Exclusion Criteria for Leukapheresis for Part B, Arm B.2:\n\n* Prior CD19-directed cellular therapy.",{"count":249,"type":20},[23],"This research study involves the study of CD79b-19 CAR T cells for treating people with relapsed\u002Frefractory Non-Hodgkin Lymphoma and to understand the side effects when treated with CD79b-19 CAR T cells.\n\nThis research study involves the study drugs:\n\n* CD79b-19 CAR T cells\n* Fludarabine and Cyclophosphamide: Standardly used chemotherapy drugs as part of lymphodepleting process",[342,178,179,182,183,186,190,31,343,177],"Non-hodgkin Lymphoma","Grade 3b Follicular Lymphoma",[345],"Relapsed\u002FRefractory B-cell Lymphoma","2026-03-13",{"date":348,"type":46},"2026-03-16",{"date":350,"type":46},"2023-10-26",{"date":352,"type":20},"2028-01-01",{"name":354,"class":114},"Marcela V. Maus, M.D.,Ph.D.",{"id":356,"slug":357,"hasResults":11,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":361,"eligibilityCriteria":362,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":4,"enrollmentInfo":363,"targetDuration":4,"studyType":220,"phases":4,"briefSummary":365,"conditions":366,"keywords":4,"overallStatus":290,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":81},"100628603","neurocognitive-assessment-in-adults-undergoing-cd19-targeted-car-t-cell-therapy-100628603","NCT07463781","Neurocognitive Assessment in Adults Undergoing CD19 Targeted CAR-T Cell Therapy","Neurocognitive Assessment in Adults Undergoing CD19 Targeted CAR-T Cell Therapy: a Multicenter Observational Prospective Study","NEURO_CAR-T","Inclusion Criteria:\n\n* Patients with previous diagnosis of Diffuse Large B Cell Lymphoma or High- Grade B Cell Lymphoma (DLBCL\u002FHGBL), arising de novo or transformed from a previous indolent histotype (transformed Follicular Lymphoma or transformed Marginal Zone Lymphoma), Primary Mediastinal B Cell Lymphoma (PMBCL).\n* Patients undergoing CD19-targeted CAR-T cell salvage therapy for relapsed\u002Frefractory disease according to AIFA inclusion criteria.\n* Age over 18-years-old at the time of lymphoma diagnosis.\n\nExclusion Criteria:\n\n* Patient with histological diagnosis of mantle cell lymphoma (MCL) or acute lymphoblastic leukemia (ALL)\n* Patients with CNS disease localization.\n* Patients that received brain\u002Fneuroaxis radiotherapy.\n* Pre-existing severe psychiatric or neurologic comorbidities influencing neurocognitive assessment.",{"count":364,"type":20},100,"This is an observational, multicenter, prospective cohort study including patients treated with CAR-T in Italian centers. Patients eligible for enrollment in the study will be consecutively included in Italian FIL centers. A longitudinal survey will be carried out by collecting patients' data before starting CAR-T (T0) and after 6 (T1), 12 (T2) and 24 (T3) months after CAR-T infusion.",[96,97,367],"Primary Mediastinal B-cell Lymphoma (PMBCL)","2026-03-11",{"date":346,"type":46},{"date":371,"type":20},"2026-05",{"date":373,"type":20},"2029-05",{"name":375,"class":114},"Fondazione Italiana Linfomi - ETS",{"id":377,"slug":378,"hasResults":11,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":4,"eligibilityCriteria":382,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":383,"enrollmentInfo":384,"targetDuration":4,"studyType":21,"phases":385,"briefSummary":386,"conditions":387,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":399},"100458978","phase-1-acalabrutinib-maintenance-for-the-treatment-of-patients-with-large-b-cell-lymphoma-100458978","NCT05256641","Acalabrutinib Maintenance for the Treatment of Patients With Large B-cell Lymphoma","Acalabrutinib Maintenance Following Cellular Therapy for Large B-Cell Lymphoma Patients at Very High Risk for Relapse","Inclusion Criteria:\n\n* Ages 18-70 years\n* One of the following:\n\n  * Patients undergoing autologous stem cell transplantation (ASCT) or any Food and Drug Administration (FDA)-approved chimeric antigen receptor (CAR) T-cell therapy product for:\n\n    * High grade B-cell lymphoma (double or triple hit) with rearrangements in bcl-2 and\u002For bcl-6, and rearrangement in myc\n    * Large B-cell lymphoma with a history of secondary CNS involvement\n    * Histologic transformation of indolent lymphoma to large B-cell lymphoma, including marginal zone lymphoma, follicular lymphoma, chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), lymphoplasmacytic leukemia, or Waldenstrom macroglobulinemia\n    * High risk international prognostic index (IPI) score 4 or 5, at diagnosis or prior to CAR T-cell leukapheresis\n  * Patients undergoing allogeneic hematopoietic cell transplantation (alloHCT) for large B-cell lymphoma\n* Eastern Cooperative Oncology Group (ECOG) 0-2\n* Requirements for post-ASCT and post-alloHCT participants:\n\n  * Disease status of partial response (PR) or complete response (CR) prior to transplantation\n  * Receive reduced-intensity conditioning regimen\n  * Enrollment no later than day +90\n* Requirements for post-CAR T-cell therapy participants:\n\n  * Disease status of PR or CR after post-CAR T-cell therapy positron emission tomography (PET)-computed tomography (CT) at 1-3 months\n  * Enrollment no later than day +104\n* Ability to give full informed consent\n* Female subjects who are sexually active and can bear children must agree to use highly effective forms of contraception while on the study and for 2 days after the last dose of acalabrutinib\n* Willing and able to participate in all required evaluations and procedures in this study protocol, including swallowing capsules and tablets without difficulty\n* Absolute neutrophil count (ANC) \\> 500\u002FuL (microliters)\n* Platelets \\> 50,000\u002FuL independent of transfusions\n* Hemoglobin \\> 8 g\u002FdL independent of transfusions\n* Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\\\u003C 3 x upper limit of normal (ULN)\n* Total bilirubin =\\\u003C 1.5 x ULN, unless directly attributable to Gilbert's syndrome\n* Creatinine clearance \\>= 60 mL\u002Fmin based on Cockcroft-Gault glomerular filtration rate (GFR) and serum creatinine (Cr) =\\\u003C 1.8 mg\u002FdL\n\nExclusion Criteria:\n\n* Cord blood as donor source in alloHCT\n* New York Heart Association Class III or IV\n* Left ventricular ejection fraction \\\u003C 50%\n* Estimated glomerular filtration rate \\\u003C 30 mL\u002Fmin\n* Concurrent long-term use of posaconazole or other strong CYP3A4 inhibitors and unable to replace with equivalent medication\n* Acute or chronic graft-versus-host disease (GvHD) \\>= stage 3 at time of enrollment\n* Received packed red blood cells (pRBC) transfusion within the past 2 weeks\n* Received platelet transfusion within the past 1 week\n* Active invasive fungal infection\n* Active bacterial or viral infection until resolution of the infection\n* History of or ongoing confirmed progressive multifocal leukoencephalopathy (PML)\n* Received any investigational drug within 30 days or 5 half-lives (whichever is shorter) before first dose of study drug\n* Major surgical procedure within 30 days before the first dose of study drug. Note: If a subject had major surgery, they must have recovered adequately from any toxicity and\u002For complications from the intervention before the first dose of study drug\n* Refractory nausea and vomiting, inability to swallow the formulated product, or malabsorption syndrome; chronic gastrointestinal disease, gastric restrictions, or bariatric surgery such as gastric bypass; partial or complete bowel obstruction, or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretion of study treatment\n* Received a live virus vaccination within 28 days of first dose of study drug\n* Known history of infection with human immunodeficiency virus (HIV)\n* History of bleeding diathesis (e.g., hemophilia, von Willebrand disease)\n* Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists\n* Requires treatment with a strong cytochrome P450 3A (CYP3A) inhibitor or inducer. The use of strong CYP3A inhibitors within 1 week or strong CYP3A inducers within 3 weeks of the first dose of study drug is prohibited\n* Breastfeeding or pregnant\n* Concurrent participation in another therapeutic clinical trial","70 Years",{"count":249,"type":20},[23,24],"This phase Ib\u002FII trial studies the side effects and efficacy of maintenance acalabrutinib following cellular therapy in treating patients with large B-cell lymphoma at very high risk of the cancer coming back. Acalabrutinib is a small molecular inhibitor that may interfere with the ability of cancer cells to grow and spread.",[153,31,388,389],"Transformed Lymphoma","Secondary Central Nervous System Lymphoma","2026-03-06",{"date":392,"type":46},"2026-03-10",{"date":394,"type":46},"2023-01-23",{"date":396,"type":20},"2028-01-31",{"name":398,"class":114},"Jonsson Comprehensive Cancer Center",3,{"id":401,"slug":402,"hasResults":11,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":4,"eligibilityCriteria":406,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":4,"enrollmentInfo":407,"targetDuration":4,"studyType":21,"phases":409,"briefSummary":410,"conditions":411,"keywords":429,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":171},"100481055","phase-1-study-of-sgr-1505-in-mature-b-cell-neoplasms-100481055","NCT05544019","Study of SGR-1505 in Mature B-Cell Neoplasms","A Phase 1, Open-Label, Multicenter, Dose Escalation Study of SGR-1505 as Monotherapy in Subjects With Mature B-Cell Malignancies","Inclusion Criteria:\n\n* Subject must have a history of histologically or cytologically confirmed mature B-cell malignancy.\n* Subject must have measurable or detectable disease according to the applicable disease-specific classification system and meet criteria for initiation of treatment.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Life expectancy ≥ 12 weeks.\n\nExclusion Criteria:\n\n* The subject is in need of immediate cytoreductive therapy (unless the patient has no remaining treatment choice with potential benefit).\n* Subject has previous invasive malignancy in the last 2 years.\n* Subject has a known allergy to SGR-1505 or excipients of SGR-1505.\n* Subject has symptomatic or active CNS involvement of disease.\n* Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that would place the participant at increased risk to the use of an investigational drug.",{"count":408,"type":20},98,[23],"The purpose of this study is to evaluate safety and tolerability and to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and\u002For recommended dose (RD) of SGR-1505.",[412,317,197,198,413,182,414,415,416,316,417,31,418,419,177,420,421,188,422,423,424,314,425,426,427,428],"Mature B-Cell Neoplasm","MALT Lymphoma","Pediatric-Type Follicular Lymphoma","IRF4 Gene Rearrangement","EBV-Positive DLBCL, Nos","Plasmablastic Lymphoma","Primary Cutaneous Follicle Center Lymphoma","Primary Effusion Lymphoma","DLBCL Germinal Center B-Cell Type","Primary Mediastinal Large B Cell Lymphoma","ALK-Positive Large B-Cell Lymphoma","Primary Cutaneous Diffuse Large B-Cell Lymphoma","Splenic Marginal Zone Lymphoma","Nodal Marginal Zone Lymphoma","HHV8-Positive DLBCL, Nos","Lymphoplasmacytic Lymphoma","Duodenal-Type Follicular Lymphoma",[430,431,198],"MALT1","NF-kB","2026-02-11",{"date":434,"type":46},"2026-02-13",{"date":436,"type":46},"2023-04-10",{"date":438,"type":20},"2027-11",{"name":440,"class":53},"Schrödinger, Inc.",{"id":442,"slug":443,"hasResults":11,"nctId":444,"briefTitle":445,"officialTitle":446,"acronym":4,"eligibilityCriteria":447,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":4,"enrollmentInfo":448,"targetDuration":4,"studyType":21,"phases":450,"briefSummary":452,"conditions":453,"keywords":454,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":464,"locationsCount":140},"100569406","ctdna-guided-therapy-optimization-in-newly-diagnosed-dlbcl-100569406","NCT06693830","ctDNA-guided Therapy Optimization in Newly Diagnosed DLBCL","Sequencing-guided cHemotherapy Optimization Using Real-Time Evaluation in Newly Diagnosed DLBCL With Circulating Tumor DNA: SHORTEN-ctDNA","Inclusion Criteria:\n\n1. Patients with newly diagnosed, histologically confirmed CD20+ DLBCL\n\n   * Stage II-IV disease\n   * Planned for anthracycline-based therapy with standard dosed R-CHOP or R-pola- CHP without consolidative radiation\n   * Measurable disease on cross sectional imaging ≥ 1.5 cm in longest diameter and measurable in two perpendicular dimensions, with at least one corresponding hypermetabolic lesion by Lugano classification on baseline FDG PET\u002FCT or CT with intravenous contrast of the chest, abdomen, and pelvis if FDG PET\u002FCT not available.\n2. Age 18 years or older at time of screening\n3. Subject\u002Flegal representative willing and able to provide written informed consent\n4. Ability to comply with outpatient treatment, laboratory monitoring, and required clinic visits for duration of study participation\n5. Organ function as assessed by laboratory and cardiac function testing and Eastern Cooperative Oncology Group (ECOG) performance status in appropriate range for receipt of R-CHOP or R-pola-CHP at standard dose as per treating physician\n\nExclusion Criteria:\n\n1. Previous treatment for diffuse large B-cell lymphoma, except as outlined below:\n\n   * Up to 14 days of corticosteroids for the relief of lymphoma-related symptoms\n   * A dose of pre-phase vincristine or rituximab\n   * One cycle of R-chemotherapy (including but not limited to R-CHOP, R-pola-CHP, dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, rituximab \\[DA-EPOCH-R) that has not started more than 28 days prior to consent\n   * Intrathecal chemotherapy for central nervous system (CNS) prophylaxis\n   * Radiation therapy for the treatment or prevention of spinal cord compression that has not started more than 28 days prior to enrollment\n2. Simultaneous participation in other treatment clinical protocol\n3. Planned anti-lymphoma therapies beyond R-CHOP or R-pola-CHP:\n\n   * Consolidative radiation to any baseline sites of disease\n   * Planned high-dose intravenous methotrexate for central nervous system (CNS) lymphoma prophylaxis (both mid-cycle and EOT excluded)\n\n     * Any number of doses of intrathecal chemotherapy for CNS lymphoma prophylaxis are allowed\n4. Transformed indolent lymphoma (including follicular lymphoma, marginal zone lymphoma, or lymphoplasmacytic lymphoma) or grade IIIB follicular lymphoma\n5. Known CNS involvement by lymphoma. R-CHOP and R-pola- CHP are insufficient to treat CNS disease.\n6. Any disease characteristics that would make R-CHOP or R-pola-CHP without radiation insufficient therapy at the discretion of the treating physician\n\n   * High-grade B-cell lymphoma with rearrangement of MYC and BCL2, primary mediastinal B-cell lymphoma, and HIV-associated lymphomas are excluded\n7. Richter transformation of chronic lymphocytic leukemia\n8. Pregnancy and\u002For nursing period. R-CHOP and R-pola-CHP may cause fetal harm or birth defects, and effects of exposure in the breastfed infant are unknown.\n\n   * A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"childbearing potential\"\n   * Women of childbearing potential are eligible if a negative serum or urine beta human chorionic gonadotropin pregnancy test is documented within 28 days of screening, and they must agree to us an effective contraception method during systemic treatment\n   * Men who have partners of childbearing potential must agree to use an effective contraceptive method during systemic treatment\n   * In addition to routine contraceptive methods, \"acceptable contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen.\n9. Uncontrolled active systemic infection\n\n   * Patients with a positive hepatitis B virus (HBV) core antibody and negative HBV surface antigen consistent with prior HBV exposure must be willing to take appropriate anti-viral prophylaxis.\n   * Patients with evidence of chronic HBV infection must have undetectable HBV viral load on the most recent test results obtained within the last year and received suppressive therapy.\n   * Participants with a history of hepatitis C virus (HCV) infection must have an undetectable viral load. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 28 days prior to consent.\n10. Active second malignancy unless in remission and with life expectancy \\> 2 years with exception of patients diagnosed with basal cell or squamous cell carcinoma of the skin or carcinoma \"in situ\" of the cervix or breast who are eligible even if diagnosed within 2 years. If patients have another malignancy that was treated within the last 2 years, such patients may be enrolled, if the likelihood of requiring systemic therapy for this other malignancy within 2 years is less than 10%, as determined by an expert in that particular malignancy at CUIMC, and after consultation with the Principal Investigator. Hormone therapy for treated prostate and breast cancer is allowed.\n11. Known hypersensitivity to any component of R-CHOP or R-pola-CHP",{"count":449,"type":20},40,[451],"NA","The purpose of this study is to 1) determine whether it is feasible to measure circulating tumor DNA (ctDNA) in real-time during standard treatment for newly diagnosed diffuse large B-cell lymphoma (DLBCL), and 2) evaluate the outcomes of participants with undetectable ctDNA in the middle of treatment who receive a shortened course of chemotherapy.\n\nThere are no investigational drug agents to be administered in this study. The investigational assay, phased variant enrichment and detection sequencing (PhasED-seq) will be used to guide de-escalation of standard-of-care therapy for newly diagnosed DLBCL.\n\nThe PhasED-seq assay has not yet been approved by the Food and Drug Administration (FDA).",[223,225,186,68,31],[455,456],"circulating tumor DNA","measurable residual disease","2026-01-22",{"date":459,"type":46},"2026-01-23",{"date":461,"type":46},"2024-12-11",{"date":463,"type":20},"2029-12",{"name":465,"class":114},"Hua-Jay J Cherng, MD",{"id":467,"slug":468,"hasResults":11,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":472,"eligibilityCriteria":473,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":474,"enrollmentInfo":475,"targetDuration":4,"studyType":220,"phases":4,"briefSummary":477,"conditions":478,"keywords":480,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":488,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":493,"locationsCount":494},"100561287","exploring-the-clinical-impact-of-myc-aberrations-and-their-relationship-with-microenvironment-in-diffuse-large-b-cell-lymphoma-and-high-grade-b-cell-lymphoma-100561287","NCT06588205","Exploring the Clinical Impact of MYC Aberrations and Their Relationship With Microenvironment in Diffuse Large B Cell Lymphoma and High-Grade B Cell Lymphoma","Multicenter, Observational, Retrospective-prospective Study Exploring the Clinical Impact of MYC Aberrations and Their Relationship With Microenvironment in Diffuse Large B Cell Lymphoma and High-Grade B Cell Lymphoma","FIL_MIMYC","Inclusion Criteria:\n\n* Diagnosis of nodal and extranodal Diffuse Large B Cell Lymphoma, High Grade B Cell Lymphomas (including low-grade transformed lymphomas; double and triple hit; 11q aberration; not otherwise specified) after 1st January 2019\n* Presence of one MYC translocation or gain of copies (GCN: \\> 3 copies in more than 30% of the nuclei) or amplification evaluated by FISH\n* Availability of immunohistochemical analysis of CD10, Bcl6, MUM1, Bcl2, Myc, Ki67\n* Have received curative treatment (e.g. R-CHOP, R DA EPOCH, intensified \"Burkitt like\" chemotherapies) as first-line therapy\n* Histological material of adequate size and quality to perform histological review with any additional investigations (immunohistochemistry, FISH and other molecular analysis). A FFPE block must be provided for patient enrollment.\n* Age between 18 and 79 years\n\nExclusion Criteria:\n\n* Primary lymphomas of the central nervous system, plasmablastic lymphoma, Burkitt's lymphoma, primary mediastinal B lymphoma\n* Have received palliative treatment","79 Years",{"count":476,"type":20},200,"This is a observational, retrospective and prospective study designed to assess the potential correlations between MYC alterations, lymphoma mutational landscape and functional immune contextures in Diffuse Large B-cell Lymphoma or High-Grade B-cell Lymphoma",[186,31,479],"High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements",[186,31,481,482,483,484,485,486],"MYC","BCL2","BCL6","Double Hit","Triple Hit","lymphoma micro-environment","2025-12-22",{"date":489,"type":46},"2025-12-29",{"date":491,"type":46},"2025-05-05",{"date":137,"type":20},{"name":375,"class":114},20,{"id":496,"slug":497,"hasResults":11,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":4,"eligibilityCriteria":501,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":4,"enrollmentInfo":502,"targetDuration":4,"studyType":21,"phases":504,"briefSummary":505,"conditions":506,"keywords":514,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":520,"startDateStruct":522,"completionDateStruct":523,"leadSponsor":525,"locationsCount":272},"100572695","phase-2-a-study-of-circulating-tumor-dna-ctdna-testing-for-people-with-b-cell-lymphoma-100572695","NCT06736613","A Study of Circulating Tumor DNA (ctDNA) Testing for People With B-Cell Lymphoma","Cerebral Spinal Fluid Circulating Tumor DNA (ctDNA) Analysis in Patients With Aggressive B-cell Lymphoma Receiving Front Line Therapy and at High Risk for Central Nervous System Relapse","Inclusion Criteria:\n\n* Signed Informed Consent.\n* Ability and willingness to comply with the requirements of the study protocol.\n* Age ≥ 18 years old.\n* Diagnosis of the following histologies according to the 2016 WHO Classification for Mature Lymphoid Neoplasms81 along with a specific high-risk criteria for CNS relapse if indicated as certain diagnoses in of themselves are high-risk alone:\n\n  1. Diffuse Large B-cell Lymphoma (DLBCL) with CNS IPI score ≥ 4.\n  2. Stage III\u002FIV High Grade B-cell lymphoma (HGBCL) with MYC, BCL2, and\u002For BCL6 translocations\n  3. Primary DLBCL of Breast\n  4. Primary DLBCL of Testis\n  5. Primary Cutaneous DLBCL, Leg Type\n  6. Intravascular Large B-cell Lymphoma\n  7. Stage III\u002FIV HIV-associated DLBCL\n  8. Double expressor DLBCL (co-expression of MYC ≥ 40% and BCL2 ≥ 50% without translocations) with a CNS IPI score ≥ 3\n  9. DLBCL with the following extranodal involvement AND CNS IPI score ≥ 3:\n\n  i. Adrenal ii. Breast iii. Bone Marrow with pathological overt morphological involvement iv. Epidural\u002FParaspinal v. Nasal\u002Fparasinus with local invasion such as bone destruction vi. Renal viii. Uterine ix. Testis xi. Skull involvement without direct invasion into CNS\u002Fbrain parenchyma\n* Transformed DLBCL from any indolent B-cell lymphoma is permitted (as long as there is no prior history of CNS involvement).\n* Planned to receive standard chemoimmunotherapy.\n* Patient is able to undergo lumbar puncture without any contraindications which include but are not limited to altered mental status, increased intracranial pressure due to any CNS lesion (mass, abscess), overlying skin infection at the site of LP, inability to safely access CSF due to lymphomatous involvement (i.e. epidural mass), or inability to hold antiplatelet or anticoagulation safely for the procedure to be performed.\n* No systemic therapy prior to study enrollment for an aggressive B-cell lymphoma is permitted. Treatment for a history of indolent lymphoma is permitted. Systemic corticosteroids are permitted (must be ≤7 days and tapered down to prednisone ≤ 20 mg oral\u002Fday or steroid equivalent by first day of anthracycline treatment). Clinical exceptions in regards to steroid management can be made after discussion with PI.\n* ECOG performance status of 0 to 2.\n\nExclusion Criteria:\n\n* Active systemic therapy for another malignancy (other than indolent B-cell lymphoma) within 2 years; local\u002Fregional therapy with curative intent such as surgical resection or localized radiation within 2 years of treatment is permitted.\n* Active concurrent malignancy with the exception of basal cell or localized squamous cell skin carcinoma, localized prostate cancer, or other localized carcinomas such as carcinoma in situ of cervix, breast, or bladder.\n* Any uncontrolled illness that in the opinion of the investigator would preclude administration of curative intent chemoimmunotherapy (e.g. significant active infections, hypertension, angina, arrhythmias, pulmonary disease, or autoimmune dysfunction).\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization within 2 weeks prior to Cycle 1, Day 1.\n* Psychiatric illness or social situations that would limit the patient's ability to tolerate and\u002For comply with study requirements.",{"count":503,"type":20},50,[24],"The purpose of this study is to find out how many people with B-cell lymphoma who are at high risk for central nervous system\u002FCNS relapse test positive for cerebral spinal fluid\u002FCSF ctDNA but test negative for CNS involvement using standard tests. The study will also look at how often CNS relapse happens in people with and without detected CSF ctDNA.",[186,31,507,508,184,509,510,511,512,513],"Stage III High Grade B-Cell Lymphoma","Stage IV High Grade B-Cell Lymphoma","Intravascular Large B-Cell Lymphoma","Diffuse Large B Cell Lymphoma of Breast","Diffuse Large B Cell Lymphoma of Testis","HIV-associated Diffuse Large B Cell Lymphoma","Double Expressor DLBCL",[186,31,507,508,184,509,510,511,512,515,516,517,113,518],"Double expressor DLBCL","Circulating Tumor DNA","ctDNA","24-336","2025-12-17",{"date":521,"type":46},"2025-12-18",{"date":461,"type":46},{"date":524,"type":20},"2027-12-11",{"name":113,"class":114},{"id":527,"slug":528,"hasResults":11,"nctId":529,"briefTitle":530,"officialTitle":531,"acronym":4,"eligibilityCriteria":532,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":4,"enrollmentInfo":533,"targetDuration":4,"studyType":21,"phases":535,"briefSummary":536,"conditions":537,"keywords":539,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":548,"locationsCount":54},"100558363","phase-2-emapalumab-prevention-of-car-t-cell-associated-toxicities-100558363","NCT06550141","Emapalumab Prevention of CAR-T Cell Associated Toxicities","A Phase 2 Trial of Emapalumab for the Prevention of CAR-T Cell Associated Toxicities","Inclusion Criteria:\n\n* Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Or adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.\n* At least 1 measurable lesion per Lugano at time of screening.\n* At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy at the time the subject is planned for leukapheresis, except for systemic inhibitory\u002Fstimulatory immune checkpoint therapy however steroids only require a 7-day washout.\n* At least 3 half-lives must have elapsed from any prior systemic inhibitory\u002Fstimulatory immune checkpoint molecule therapy at the time the subject is planned for leukapheresis (e.g. ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists, etc).\n* Age 18 or older\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* Adequate renal, hepatic, pulmonary and cardiac function defined as:\n\n  * ANC ≥1000\u002FuL\n  * Platelet count ≥50,000\u002FuL\n  * Absolute lymphocyte count ≥100\u002FuL\n  * Creatinine clearance (as estimated by Cockcroft Gault or CKD-EPI) ≥ 30 mL\u002Fmin\n  * Serum ALT\u002FAST ≤2.5 per institutional ULN\n  * Total bilirubin ≤1.5 mg\u002Fdl, except in subjects with Gilbert's syndrome.\n  * Cardiac ejection fraction ≥ 40%, no clinically significant pericardial effusion, and no clinically significant ECG findings\n  * Baseline oxygen saturation \\>92% on room air.\n* Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential).\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) or follicular lymphoma unless disease free for at least 3 years.\n* History of Richter's transformation of CLL.\n* Autologous stem cell transplant within 6 weeks of planned axicabtagene ciloleucel infusion.\n* History of allogeneic stem cell transplantation.\n* Presence of uncontrolled fungal, bacterial, viral, or other infection at time of screening.\n* Known history of acute or chronic active hepatitis B or C infection. Subjects with history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing per current Infectious Diseases Society of America (IDSA) guidelines.\n\n  * Patients should also be negative for latent Tb, CMV (NAT), EBV (NAT) and adenovirus (NAT) by PCR testing.\n* No evidence of active CNS disease regardless of prior CNS history.\n* History or presence of CNS disorder such as seizure disorder, cerebrovascular ischemia\u002Fhemorrhage within 6 months of enrollment.\n* History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment.\n* History of symptomatic pulmonary embolism within 3 months of enrollment; ongoing anticoagulation is allowed if beyond 3 months.\n* Any medical condition likely to interfere with assessment of safety or efficacy of study treatment.\n* History of allergic reactions or severe immediate hypersensitivity reaction to any of the agents used in this study or compounds of similar chemical or biologic composition.\n* Females who are pregnant or breastfeeding or female or male participants who are not willing to practice birth control from the time of consent through 6 months after the completion of axicabtagene ciloleucel\n* In the investigators judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation.\n* History of autoimmune disease requiring ongoing systemic immunosuppression. Steroids are allowed up to 5mg predinosine-equivalent for adrenal insufficiency.\n* Patients anticipated to require canakinumab, JAK inhibitors, TNF inhibitors, and tocilizumab for non-CAR-T management of baseline autoimmune\u002Finflammatory disease at the time of emapalumab initiation.\n* Receipt of a BCG vaccine within 12 weeks prior to Screening.\n* Receipt of a live or attenuated live (other than BCG) vaccine within 4 weeks prior to screeing.\n* Participants who are receiving any other investigational agents for this condition.",{"count":534,"type":20},28,[24],"This research study involves assessing the impact of emapalumab as preventative management of CAR-T related cytokine release syndrome in participants with Non-Hodgkin's lymphoma (NHL).\n\nThe research study involves the following study interventions:\n\n* Fludarabine and cyclophosphamide (Lymphodepleting Chemotherapy)\n* Axicabtagene Ciloleucel\n* Emapalumab",[187,178,179,186,538,31,182],"Primary Mediastinal Large B-cell Lymphoma",[540,541],"Second Line Large B-cell Non-Hodgkin's Lymphoma","Third Line Large B-cell Non-Hodgkin's Lymphoma","2025-11-12",{"date":544,"type":46},"2025-11-14",{"date":546,"type":46},"2024-09-18",{"date":269,"type":20},{"name":354,"class":114},{"id":550,"slug":551,"hasResults":11,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":4,"eligibilityCriteria":555,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":4,"enrollmentInfo":556,"targetDuration":4,"studyType":21,"phases":558,"briefSummary":559,"conditions":560,"keywords":562,"overallStatus":290,"whyStopped":4,"lastUpdateSubmitDate":565,"lastUpdatePostDateStruct":566,"startDateStruct":568,"completionDateStruct":570,"leadSponsor":571,"locationsCount":54},"100610273","phase-1-rituximab-rtx--tafasitamab-in-combination-with-allogeneic-nk-cells-for-treatment-of-relapsedrefractory-rr-b-cell-non-hodgkin-lymphoma-nhl-100610273","NCT07225439","Rituximab (Rtx) + Tafasitamab in Combination With Allogeneic NK Cells for Treatment of Relapsed\u002FRefractory (r\u002Fr) B-cell Non-Hodgkin Lymphoma (NHL)","Phase I Clinical Trial of Rituximab (Rtx) and Tafasitamab in Combination With Allogeneic NK Cells for Treatment of Relapsed\u002FRefractory (r\u002Fr) B-cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n* Age 18 years or older\n* Diagnosis of B-cell NHL (indolent and aggressive subtypes) including diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS), high grade B-cell lymphoma (HGBCL), primary mediastinal B-cell lymphoma (PMBCL), follicular lymphoma (FL), chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL)\n* Participants must have measurable disease as defined by Lugano 2014 criteria for NHL or iwCLL 2018 criteria for CLL. For NHL, measurable disease is defined as ≥1 measurable lesion (nodal or extra nodal) ≥1.5 cm in longest diameter by CT or PET\u002FCT. For CLL, iwCLL criteria includes: presence of lymphocytosis (e.g., ALC ≥5 × 10⁹\u002FL), lymphadenopathy ≥1.5 cm, and\u002For disease-related cytopenias (anemia, thrombocytopenia).\n* Relapsed and\u002For refractory after two or more lines of systemic therapy, including prior CD19 and\u002For CD20 directed therapies\n* For participants who have received a prior CD19 or CD20 directed therapy, the presence of CD19 and\u002For CD20 expression (by flow cytometry and\u002For immunohistochemistry) must be demonstrated on a post-treatment relapse biopsy\n* ECOG Performance Status \\\u003C\u002F= 2\n* Preserved organ function as defined by: Total bilirubin \\\u003C\u002F= 1.5X upper limit of normal; AST\u002FALT \\\u003C\u002F= 2.5 X upper limit of normal; Calculated creatinine clearance \\>\u002F= 30mL\u002Fmin estimated by Cockcroft Gualt formula; cardiac ejection fraction \\>\u002F= 45% and no more than mild\u002Ftrace pericardial effusion on a recent echocardiogram; and adequate pulmonary function with oxygen saturation \\>\u002F= 92% on room air.\n* Participants must have the ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Second active malignancy (other than non-melanoma skin cancer or carcinoma in situ e.g. cervix, bladder, breast) that would confound interpretation of toxicity assessment or limit survival to prevent evaluation of therapy per discretion of principal investigator. Malignancies treated curatively or with hormonal therapy could be included after discussion with the principal investigator\n* Less than 28 days elapsed between prior treatment with investigational agent(s) and study enrollment\n* New York Heart Association class III-IV congestive heart failure\n* Cardiovascular disorders including unstable angina pectoris, clinically significant cardiac arrhythmias, myocardial infarction or stroke (including transient ischemic attack, or other ischemic event) within 6 months prior to registration\n* Known human immunodeficiency virus infection or acquired immunodeficiency syndrome related illness, except well controlled HIV with viral load \\\u003C200 copies\u002FmL on antiretroviral therapy\n* Pregnant or breastfeeding women are excluded from this study because therapy may be associated with the potential for teratogenic or abortifacient effects. Women of childbearing potential must have a negative serum pregnancy test. Because there is an unknown, but potential risk for adverse events in nursing infants' secondary to treatment of the mother with NK cells, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study\n* Morphologic and\u002For cytogenetic features consistent with diagnosis of myelodysplastic syndrome on the most recent bone marrow biopsy prior to initiation of therapy\n* Serologic status reflecting active hepatitis B or C infection. Participants that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive participants will be excluded)\n* Participants with history of clinically relevant CNS pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease\n* Active central nervous system or leptomeningeal involvement by lymphoma. Participants with untreated brain metastases\u002FCNS disease will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurological and other adverse events. Participants with a history of CNS or meningeal involvement must be in a documented remission by CSF evaluation and contrast enhanced MRI imaging for at least 90 days prior to registration\n* History of active autoimmune disease (i.e. rheumatoid arthritis, systemic lupus erythematosus) with requirement of systemic immunosuppressive medications other than low dose steroids \\[i.e. maximum of 15mg prednisone equivalent\\] within the last 6 months",{"count":557,"type":20},15,[23],"This research study is for people who have relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL) that has not responded to two or more lines of therapy. The purpose of this study is to identify the recommended dose of allogeneic NK cells in combination with IL-2, Tafasitamab and Rituximab for the treatment of relapsed or refractory B-cell non-Hodgkin's lymphoma.\n\nNK cells are an investigational (experimental) treatment which means they are not approved by the Food and Drug Administration (FDA). NK cells are a type of lymphocyte that's part of the body's natural immune system, and they can kill cancer cells by creating pores in the cancer cell membranes and inducing apoptosis (programmed cell death).\n\nParticipants in this study will receive lymphodepleting chemotherapy, as well as Allogeneic NK cells, Tafasitamab and Interleukin-2 (IL-2) by an intravenous (IV) infusion. Participants are expected to complete one cycle, and they may be eligible to complete a second cycle of the same regiment if they have stable disease, partial or complete remission at the end of the first cycle. Participants will be in this study for about 12 months.",[317,561,186,31,421,182,314,315,183,177],"B-cell Non Hodgkin Lymphoma",[563,564],"NK cells","Natural Killer cells","2025-11-04",{"date":567,"type":46},"2025-11-06",{"date":569,"type":20},"2025-12",{"date":137,"type":20},{"name":572,"class":114},"Paolo Caimi, MD",{"id":574,"slug":575,"hasResults":11,"nctId":576,"briefTitle":577,"officialTitle":578,"acronym":4,"eligibilityCriteria":579,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":4,"enrollmentInfo":580,"targetDuration":4,"studyType":21,"phases":582,"briefSummary":583,"conditions":584,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":589,"lastUpdatePostDateStruct":590,"startDateStruct":592,"completionDateStruct":594,"leadSponsor":596,"locationsCount":599},"100507666","phase-2-study-adding-drugs-to-usual-treatment-for-large-b-cell-lymphoma-that-returned-or-did-not-respond-to-treatment-100507666","NCT05890352","Study Adding Drugs to Usual Treatment for Large B-Cell Lymphoma That Returned or Did Not Respond to Treatment","Randomized Phase II Study of the Addition of Targeted Therapeutic Agents to Tafasitamab-Based Therapy in Non-Transplant-Eligible Patients With Relapsed\u002FRefractory Large B-Cell Lymphoma","Inclusion Criteria:\n\n* Participants must have:\n\n  * Histologically confirmed relapsed\u002Frefractory LBCL as outlined by the World Health Organization (WHO) guidelines\n  * Follicular lymphoma, grade 3B\n  * Transformed lymphoma\n  * High grade B-cell lymphoma with or without MYC, BCL2 and\u002For BCL6 rearrangements\n* Participants must have staging imaging performed within 28 days prior to registration, as follows. Positron emission tomography (PET)-computed tomography (CT) baseline scans are strongly preferred; diagnostic quality magnetic resonance imaging (MRI), contrast-enhanced CT, or contrast-enhanced MRI scans are also acceptable if PET-CT is not feasible at baseline. Note: PET-CT will be required at end of treatment (EOT) and progression for response assessment. All measurable lesions (longest diameter \\>= 1.5 cm) must be assessed within 28 days prior to registration. Tests to assess non-measurable disease must be performed within 28 days prior to registration. All disease must be documented on the Baseline Tumor Assessment Form.\n* Participants must have cell of origin (COO) determination of germinal center (GC)(GCB or non-GC GCB) of LBCL based on Hans immunohistochemistry algorithm (CD10, BCL6, MUM1) as noted on pathology report.\n* Participants must have had 1-5 prior systemic treatment regimens including one systemic multiagent regimen for aggressive lymphoma\n* Participants who have received prior systemic therapy must have completed their last treatment prior to registration. Participants must have recovered from previous therapy\n* Steroid use for the control of non-Hodgkin lymphoma symptoms is allowable, but must be discontinued prior to Cycle 1, Day 1\n* Participant must be \\>= 18 years old\n* Participant must have Zubrod Performance Status of 0-3\n* Participant must have a complete medical history and physical exam within 28 days prior to registration\n* Absolute neutrophil count \\>= 1.0 x 10\\^3\u002FuL (within 28 days prior to registration)\n\n  * If there is documented lymphomatous involvement of the bone marrow as assessed by bone marrow biopsy within 90 days prior to registration, participants must have: Absolute neutrophil count (ANC) \\>= 0.75 x 10\\^3\u002FuL\n* Platelets \\>= 75 x 10\\^3\u002FuL (within 28 days prior to registration)\n\n  * If there is documented lymphomatous involvement of the bone marrow as assessed by bone marrow biopsy within 90 days prior to registration, participants must have: Platelets \\>= 50 x 10\\^3\u002FuL\n* Aspartate aminotransferase (AST) =\\\u003C 3 x institutional upper limit of normal (IULN), alanine aminotransferase (ALT) =\\\u003C 3 x IULN (within 28 days prior to registration) unless due to Gilbert's disease, hemolysis, or lymphomatous involvement of liver.\n\n  * Participants with lymphomatous involvement of the liver must have AST =\\\u003C 5 x IULN, ALT =\\\u003C 5 x IULN\n* Total bilirubin =\\\u003C 1.5 x IULN (within 28 days prior to registration) unless due to Gilbert's disease, hemolysis, or lymphomatous involvement of liver.\n\n  * Participants with lymphomatous involvement of the liver must have total bilirubin =\\\u003C 5 x IULN\n* Participants must have a calculated creatinine clearance \\>= 30 mL\u002Fmin using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration\n* Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* Participants must have recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> Grade 1) with the exception of alopecia\n* Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at randomization and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration\n* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on the most recent test results obtained within the last year and received suppressive therapy\n* Participants with a history of hepatitis C virus (HCV) infection must have an undetectable viral load. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 28 days prior to registration\n* Participants must be able to swallow and retain orally administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption, such as malabsorption syndrome or major resection of the stomach or bowels\n* Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen Tracking System\n* Participants who can complete the FACT-Lym and PRO-CTCAE forms in English or Spanish must agree to participate in the patient-reported outcome study\n* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.\n\n  * For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and central institutional review board (CIRB) regulations.\n\nExclusion Criteria:\n\n* Participants must not have active lymphomatous involvement of the central nervous system (CNS) because the treatments used in this study are not effective to sufficiently penetrate the blood brain barrier\n* Participants must not have known abnormalities associated with myelodysplastic syndrome (MDS) (e.g., del 5q, chr 7 abn) and myeloproliferative neoplasms (MPN) (e.g., JAK2 V617F) observed in cytogenetic testing and deoxyribonucleic acid (DNA) sequencing. Testing is not required for eligibility determination\n* Participants must not have a known prior history of T-cell lymphoblastic lymphoma (T-LBL)\u002FT-cell acute leukemia (T-ALL). Testing is not required for eligibility determination\n* Participants must not be a candidate based on investigator assessment to receive autologous stem cell transplant (ASCT) or must have declined ASCT. Participants who had disease progression after stem cell transplant or cellular therapy (such as chimeric antigen receptor (CAR) T-cell) are eligible\n* Participants must not have received prior treatment with tafasitamab and\u002For lenalidomide\n* Participants must not have had prior BTK inhibitor or tazemetostat\n* Participants must not have any known allergy or reaction to any component of tafasitamab, lenalidomide, tazemetostat or zanubrutinib\n* Participants must not be receiving direct vitamin K inhibitors or strong or moderate CYP3A inhibitors or inducers at the date of registration\n\n  * Notes: Because the list of these agents is constantly changing, it is important to regularly consult a frequently updated medical reference\n* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Participants must not be pregnant or nursing and must follow the guidelines according to the lenalidomide Risk Evaluation and Mitigation Strategies (REMS) program. The effects of tazemetostat, zanubrutinib, lenalidomide and tafasitamab, and the combination of these drugs have not been studied on the developing human fetus are the effects are unknown. Individuals who are of reproductive potential must have agreed to use a highly effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential\". In addition to routine contraceptive methods, \"acceptable contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen",{"count":581,"type":20},227,[24],"This phase 2 trial studies the side effects and best dose of tazemetostat and zanubrutinib in combination with tafasitamab and lenalidomide, and to see how well these combinations work in treating patients with large B-cell lymphoma that returned or did not respond to earlier treatment. Tazemetostat is in a class of medications called EZH2 inhibitors. It helps to stop the spread of cancer cells. Zanubrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells. tafasitamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Lenalidomide is in a class of medications called immunomodulatory agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells in the bone marrow. The addition of tazemetostat or zanubrutinib to tafasitamab and lenalidomide may be able to shrink the cancer or extend the time without cancer symptoms coming back.",[343,69,585,586,587,588],"High Grade B-Cell Lymphoma With MYC and BCL2 and\u002For BCL6 Rearrangements","Recurrent Diffuse Large B-Cell Lymphoma","Refractory Diffuse Large B-Cell Lymphoma","Transformed Non-Hodgkin Lymphoma","2025-10-16",{"date":591,"type":46},"2025-10-20",{"date":593,"type":46},"2023-09-26",{"date":595,"type":20},"2029-01",{"name":597,"class":598},"SWOG Cancer Research Network","NETWORK",104,{"id":601,"slug":602,"hasResults":11,"nctId":603,"briefTitle":604,"officialTitle":605,"acronym":606,"eligibilityCriteria":607,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":4,"enrollmentInfo":608,"targetDuration":4,"studyType":21,"phases":610,"briefSummary":611,"conditions":612,"keywords":622,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":626,"lastUpdatePostDateStruct":627,"startDateStruct":629,"completionDateStruct":631,"leadSponsor":633,"locationsCount":54},"100542472","phase-1-t-cell-therapy-eb103-in-adults-with-relapsedrefractory-b-cell-non-hodgkins-lymphoma-nhl-100542472","NCT06343311","T-Cell Therapy (EB103) in Adults With Relapsed\u002FRefractory B-Cell Non-Hodgkin's Lymphoma (NHL)","An Open-Label, Dose Escalation, Multi-Center Phase I\u002FII Clinical Trial of EB103 T-Cell Therapy in Adults With Relapsed\u002FRefractory (R\u002FR) B-Cell Non-Hodgkin's Lymphoma (NHL)","STARLIGHT-1","Inclusion Criteria:\n\n* Age 18 years or older at the time of informed consent\n* Histologically confirmed R\u002FR B-cell non-Hodgkin's lymphoma (NHL)\n* Adequate organ function\n* Relapsed or refractory (R\u002FR) disease defined as ONE OR MORE of the following:\n\n  * R\u002FR after ≥ 2 lines of systemic therapy\n\n    * For the following NHL types: Burkitt lymphoma, Precursor B-cell lymphoblastic lymphoma, or Mantle cell lymphoma: R\u002FR after ≥ 1 lines of systemic therapy\n  * Disease progression or recurrence ≤ 12 months after autologous hematopoietic stem cell transplantation (HSCT)\n  * For subjects who are considered transplant-ineligible: progressive disease as best response after ≥ 4 cycles of first-line therapy and stable disease as best response after ≥ 2 cycles of second-line (salvage) therapy; subject must have received an anti-CD20 monoclonal antibody and an anthracycline as one of their qualifying regimens\n* All subjects must have received an appropriate chemoimmunotherapy regimen which at a minimum includes an:\n\n  * Anti-CD20 monoclonal antibody AND\n  * An anthracycline-containing chemotherapy regimen\n* Positron emission tomography (PET)-positive disease according to Cheson 2014\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Toxicities due to prior therapy must be stable and recovered to Grade 1 or less\n\nExclusion Criteria:\n\n* Prior CD19-targeted cellular therapy\n* History of Richter's transformation of chronic lymphocytic leukemia (CLL)\n* History of another primary malignancy that has not been in remission for ≥ 2 years.\n* History or presence of clinically relevant Central Nervous System (CNS) pathology\n* CNS disease which is progressing on most recent therapy or with a parenchymal mass which is likely to cause clinical symptoms\n* Subjects with active cardiac lymphoma involvement which is not responding to treatment\n* History of myocardial infarction, cardiac angioplasty and stenting, unstable angina, or other clinically significant cardiac disease within 6 months of informed consent\n* Active, uncontrolled systemic bacterial, fungal, or viral infection. Patients with HIV, hepatitis B, or hepatitis C are eligible provided their infection is being treated and the viral load is controlled.\n* History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression\u002Fsystemic disease modifying agents within the last 2 years\n* History of severe, immediate hypersensitivity reaction to any agents used in this study, including the conditioning chemotherapeutic agents\n* Venous thrombosis or embolism not managed on a stable regimen of anticoagulation\n* Autologous HSCT within 3 months of informed consent\n* Subjects with a prior allogeneic transplant at least 6 months prior to study enrollment are eligible unless experienced graft-versus-host disease (GvHD) that requires ongoing treatment with systemic steroids or other systemic GvHD therapy, such as a calcineurin inhibitor, within 12 weeks of initial screening\n* Live vaccine within 3 months prior to planned start of conditioning regimen",{"count":609,"type":20},21,[23,24],"This is an open-label, dose escalation, multi-center, Phase I\u002FII clinical trial to assess the safety of an autologous T-cell therapy (EB103) and to determine the Recommended Phase II Dose (RP2D) in adult subjects (≥ 18 years of age) who have relapsed\u002Frefractory (R\u002FR) B-cell NHL. The study will include a dose escalation phase followed by an expansion phase.",[613,614,615,616,254,617,618,223,179,178,127,619,620,31,621],"B-Cell Non-Hodgkin's Lymphoma (NHL)","Lymphoma, Non-Hodgkins","Lymphomas Non-Hodgkin's B-Cell","Non-Hodgkin Lymphoma","Large B-Cell Lymphoma","Lymphoma, Non-Hodgkin's, Adult","HIV Associated Lymphoma","CNS Lymphoma","Refractory B-Cell Non-Hodgkin Lymphoma",[623,254,624,223,617,179,178,625,620,31,621],"B-Cell Non-Hodgkin's Lymphoma","NHL","HIV Lymphoma","2025-08-04",{"date":628,"type":46},"2025-08-07",{"date":630,"type":46},"2024-06-01",{"date":632,"type":20},"2027-12-31",{"name":634,"class":53},"Estrella Biopharma, Inc.",{"id":636,"slug":637,"hasResults":11,"nctId":638,"briefTitle":639,"officialTitle":640,"acronym":4,"eligibilityCriteria":641,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":4,"enrollmentInfo":642,"targetDuration":4,"studyType":21,"phases":644,"briefSummary":645,"conditions":646,"keywords":647,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":651,"lastUpdatePostDateStruct":652,"startDateStruct":654,"completionDateStruct":656,"leadSponsor":658,"locationsCount":660},"100489997","phase-1-a-study-to-evaluate-the-pharmacokinetics-and-safety-of-loncastuximab-tesirine-in-participants-with-relapsed-or-refractory-diffuse-large-b-cell-lymphoma-or-high-grade-b-cell-lymphoma-with-hepatic-impairment-lotis-10-100489997","NCT05660395","A Study to Evaluate the Pharmacokinetics and Safety of Loncastuximab Tesirine in Participants With Relapsed or Refractory Diffuse Large B-cell Lymphoma or High-grade B-cell Lymphoma With Hepatic Impairment (LOTIS-10)","A Phase 1b Open-Label Study to Evaluate the Pharmacokinetics and Safety of Loncastuximab Tesirine in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma or High-grade B-cell Lymphoma With Hepatic Impairment (LOTIS-10)","Inclusion Criteria:\n\n* Male or female participants aged 18 years or older\n* Pathologic diagnosis of relapsed (disease that has recurred following a response) or refractory (disease that failed to respond to prior therapy) DLBCL not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma (2016 World Health Organization classification) who have received at least one systemic treatment regimen\n* Measurable disease as defined by the 2014 Lugano Classification\n* Normal hepatic function or hepatic impairment as defined by the National Cancer Institute Organ Dysfunction Working Group hepatic impairment classification:\n\n  * Arm A Normal hepatic function: bilirubin and aspartate aminotransferase (AST) ≤ upper limit of normal (ULN)\n  * Arm B Moderate hepatic impairment: bilirubin \\> 1.5 × to 3 × ULN (any AST)\n  * Arm C Severe hepatic impairment: bilirubin \\> 3 × ULN (any AST)\n* ECOG performance status 0 to 2 for participants with normal hepatic function. ECOG 0 to 3 for participants with moderate or severe hepatic impairment\n* Adequate organ function\n* Women of childbearing potential (WOCBP)\\* must agree to use a highly effective method of contraception from the time of giving informed consent until at least 10 months after the last dose of study drug. Men with female partners who are of childbearing potential must agree to use a condom when sexually active or practice total abstinence from the time of the first dose until at least 7 months after the last dose of study drug.\n\nExclusion Criteria:\n\n* Previous therapy with loncastuximab tesirine\n* Allogenic or autologous stem cell transplant within 60 days prior to start of study drug (C1D1)\n* Human immunodeficiency virus (HIV) seropositive\n* Serologic evidence of chronic hepatitis B virus (HBV) infection and unable or unwilling to receive standard prophylactic antiviral therapy or with detectable HBV viral load\n* Serologic evidence of hepatitis C virus (HCV) infection without completion of curative treatment or with detectable HCV viral load\n* History of Stevens-Johnson syndrome or toxic epidermal necrolysis\n* Lymphoma with active central nervous system involvement at the time of screening, including leptomeningeal disease\n* Breastfeeding or pregnant\n* Significant medical comorbidities\n* Major surgery, radiotherapy, chemotherapy, or other anti-neoplastic therapy, within 14 days prior to start of study drug (C1D1), except shorter if approved by the Sponsor",{"count":643,"type":20},56,[23],"The primary objective of this study is to determine the recommended dosing regimen of loncastuximab tesirine in diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBCL) participants with moderate and severe hepatic impairment.",[153,31],[648,223,197,649,650],"Loncastuximab Tesirine","HGBCL","Hepatic Impairment","2025-07-14",{"date":653,"type":46},"2025-07-16",{"date":655,"type":46},"2023-08-28",{"date":657,"type":20},"2027-04-05",{"name":659,"class":53},"ADC Therapeutics S.A.",14,{"id":662,"slug":663,"hasResults":11,"nctId":664,"briefTitle":665,"officialTitle":666,"acronym":4,"eligibilityCriteria":667,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":668,"enrollmentInfo":669,"targetDuration":4,"studyType":220,"phases":4,"briefSummary":671,"conditions":672,"keywords":677,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":682,"lastUpdatePostDateStruct":683,"startDateStruct":685,"completionDateStruct":687,"leadSponsor":689,"locationsCount":54},"100577301","immunotherapy-in-lymphoma-100577301","NCT06796517","Immunotherapy in Lymphoma","Risk Factor Analysis Study for the Efficacy Comparison Between Advanced Immunochemotherapy and Classical Immunochemotherapy: a Prospective Study for Relapsed\u002FRefractory Lymphoma Patients","Inclusion Criteria:\n\n* Adults aged 19 to 74 years.\n* Diagnosed with any of the following after January 2015: diffuse large B cell lymphoma, primary mediastinal large B cell lymphoma, high grade B cell lymphoma, or Burkitt lymphoma\n* Patients who have received immunochemotherapy as treatment for relapsed\u002Frefractory lymphoma\n\nExclusion Criteria:\n\n* Patients who have progressed to acute leukemia\n* Patients who developed solid tumor during treatment\n* Patients with active infectious status (acute pneumonia, viral infection, active hepatitis B state, or active pulmonary tuberculosis etc.)","74 Years",{"count":670,"type":20},72,"The goal of this observational study is to compare the efficacy of advanced immunochemotherapy and classical immunochemotherapy in relapsed\u002Frefractory high grade B cell lymophoma patients. The main question it aims to answer is:\n\nDoes advanced immunochemotherapy, including CAR-T therapy, bispecific antibody, and antibody-drug conjugate offer superior survival outcomes than when treated with classical immunochemotherapy, such as proteasome inhibitors, immune modulatory drugs, and monoclonal antibodies?\n\nResearchers will compare patients receiving advanced immunochemotherapy with those receiving classical immunochemotherapy to determine if advanced therapies result in better survival outcomes.\n\nLaboratory findings and electronic medical records (EMR) from participants will be used to assess survival outcomes and treatment-related safety profiles.",[673,674,675,676,316],"Relapsed\u002Frefractory High Grade B Cell Lymphoma","High Grade B-cell Lymphoma","Diffuse Large B Cell Lymphoma Relapsed","Primary Mediastinal Large B-Cell Lymphoma",[678,679,680,681],"immunochemotherapy","B cell lymphoma","Relapsed","Refractory","2025-01-27",{"date":684,"type":46},"2025-01-28",{"date":686,"type":46},"2024-06-26",{"date":688,"type":20},"2025-12-31",{"name":690,"class":114},"Sung-Soo Park",{"id":692,"slug":693,"hasResults":11,"nctId":694,"briefTitle":695,"officialTitle":696,"acronym":4,"eligibilityCriteria":697,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":4,"enrollmentInfo":698,"targetDuration":4,"studyType":21,"phases":700,"briefSummary":701,"conditions":702,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":706,"lastUpdatePostDateStruct":707,"startDateStruct":709,"completionDateStruct":711,"leadSponsor":713,"locationsCount":140},"100538174","phase-2-epcoritamab-epcor-containing-combination-salvage-therapy-followed-by-asct--epcor-consolidation-in-patients-with-relapsed-lbcl-100538174","NCT06287398","Epcoritamab (Epcor)-Containing Combination Salvage Therapy Followed by ASCT & Epcor Consolidation in Patients With Relapsed LBCL","A Trial to Assess the Safety and Efficacy of Epcoritamab-containing Combination Salvage Therapy Followed by Autologous Stem Cell Transplantation and Epcoritamab Consolidation in Patients With Relapsed Large B-cell Lymphoma","Inclusion Criteria:\n\n1. Age 18 years or older\n2. Confirmed diagnosis of DLBCL, Not-otherwise specified (NOS), Transformation of indolent B-cell lymphoma, High-grade B-cell lymphoma (HGBCL), NOS, Diffuse-large BCL (DLBCL)\u002F High-grade B-cell lymphoma (HGBL) with MYC and BCL2 rearrangements or Follicular large B-cell lymphoma according to World Health Organization (WHO) 2016 or 2022 criteria that has relapsed or progressed after one line of chemoimmunotherapy\n3. Transplant eligible according to local assessment\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n5. Measurable disease on computed tomography (CT) scan, defined as a nodal site greater than 1.5cm in longest axis or an extranodal site greater than 1.0cm in longest axis AND baseline fluorodeoxyglucose (FDG) positron emission tomography (PET) scans must demonstrate positive lesion compatible with CT defined anatomical tumour sites\n6. Histological confirmation of tumour CD20 positivity, analysed by immunohistochemistry, on a pre-enrolment tissue sample performed after most recent prior therapy\n7. Adequate renal function\n\n   \\- Creatinine clearance greater than 45mL per min (Cockcroft Gault formula)\n8. Adequate hepatic function:\n\n   * Aspartate transaminase (AST) and alanine transaminase (ALT) less than or equal to 3x Upper Limit of Normal (ULN)\n   * Bilirubin less than or equal to 1.5x Upper Limit of Normal (ULN) or less than or equal to 3 if documented liver involvement and\u002For Gilbert's disease.\n9. Adequate haematologic function:\n\n   * Haemoglobin greater than or equal to 90g\u002FL (transfusion support permitted)\n   * Absolute neutrophil count greater than or equal to 1.0 x 109 per L; growth factor support allowed in case of bone marrow involvement\n   * Platelet count greater than 75 x 109 per L or greater than or equal to 50 x 109 per L if documented marrow involvement\n10. Able to take oral medications\n11. Adequate washout of prior therapies:\n\n    * At least 4 weeks since last dose of immunochemotherapy, radio-conjugated or toxin-conjugated compound, or other investigational anti-cancer therapy\n    * At least 6 weeks since chimeric antigen-receptor T-cell therapy\n12. Resolution of toxicities from prior therapy to a grade that does not contraindicate trial participation in the opinion of the investigator\n13. If receiving glucocorticoid treatment at screening, treatment must be tapered down and administered with a maximum of 25 mg daily in the last 14 days before the first dose of Epcoritamab\n14. Before the first dose of Epcoritamab, during the trial and for 12 months after last administration of Epcoritamab, a woman must be either:\n\n    1. Not of childbearing potential, defined as: premenarchal; postmenopausal (greater than 45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level greater than 40 IU per L or milli-International unit (mIU) per mL); permanently sterilized (e.g., bilateral tubal occlusion \\[which includes tubal ligation procedures as consistent with local regulations\\], hysterectomy, bilateral salpingectomy, bilateral oophorectomy); or otherwise be incapable of pregnancy\n    2. Of childbearing potential and practicing a highly effective method of birth control (as defined by the European Clinical Trial Facilitation Group) consistent with local regulations regarding the use of birth control methods for patients participating in clinical trials: e.g., established use of oral, injected or implanted combined (estradiol and progesterone containing) hormonal contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); male partner sterilization (the vasectomized partner should be the sole partner for that patient); true abstinence (when this is in line with the preferred and usual lifestyle of the patient) \\* If the childbearing potential changes after start of the trial (e.g., woman who is not heterosexually active becomes active, premenarchal woman experiences menarche) a woman must begin a highly effective method of birth control, as described under 16b\n15. A man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control (that is the use of condom) during the trial and for 12 months after receiving the last dose of Epcoritamab\n16. Women must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the trial and for 12 months after receiving the last dose of Epcoritamab. Men must also not donate sperm during the trial and for 12 months after receiving the last dose of Epcoritamab\n17. The patient understands the purpose of the trial and procedures required for the trial and is capable of giving signed informed consent which includes compliance with the requirements (no medical or psychiatric reason precluding participation) and restrictions listed in the informed consent form (ICF) and in this protocol\n\nExclusion Criteria:\n\n1. Diagnosis of primary Central Nervous System (CNS) lymphoma\n2. Active secondary CNS involvement of lymphoma at time of screening\n\n   \\- A prior history of secondary CNS lymphoma is allowed provided that it has been successfully treated and there are no features of recurrence.\n3. Prior autologous stem cell transplant\n4. Known past or current malignancy other than inclusion diagnosis, except for:\n\n   1. Cervical carcinoma of Stage 1B or less.\n   2. Non-invasive basal cell or squamous cell skin carcinoma.\n   3. Non-invasive, superficial bladder cancer.\n   4. Prostate cancer with a current Prostate Specific Agent (PSA) level less than 0.1 ng per mL e. indolent lymphoma\n   5. Indolent lymphoma\n   6. Other malignancy that has been treated with curative intent and has remained in remission for 2 years\n5. Any prior therapy with a bispecific antibody targeting CD3 and CD20\n6. Uncontrolled systemic infection\n7. Known HIV infection\n8. Known active hepatitis B or C infection based on criteria below:\n\n   * Hepatitis B virus (HBV): Patients with positive HbsAg are excluded. Patients with positive hepatitis B core antibody (antiHBc) and negative HbsAg require negative hepatitis B polymerase chain reaction (PCR) before enrolment and must be treated with antiviral therapy. Patients who are hepatitis B PCR positive will be excluded.\n   * Hepatitis C virus (HCV): If positive hepatitis C antibody, patient will need to have a negative hepatitis C ribonucleic acid (RNA) before enrolment. Patients who are hepatitis C RNA positive will be excluded.\n9. Seizure disorder, unless seizure-free for 12 months on established anticonvulsant therapy without the requirement for modification to anticonvulsants within the prior 12 months\n10. Known clinically significant cardiac disease, including:\n\n    1. Onset of unstable angina pectoris within 6 months of signing the patient informed consent form (PICF)\n    2. Acute myocardial infarction within 6 months of signing the PICF\n    3. Congestive heart failure (grade III or IV as classified by the New York Heart Association\n    4. Decreased ejection fraction of less than 45%\n11. Confirmed history or current autoimmune disease requiring permanent immunosuppressive therapy. Low-dose prednisolone (less than or equal to 10mg\u002Fday or equivalent) for rheumatoid arthritis or similar conditions is allowed.\n12. Exposed to live or live attenuated vaccine within 4 weeks prior to signing PICF\n13. Women who are pregnant or lactating.\n14. Patient has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments\n15. Known hypersensitivity or adverse reaction to rituximab, tocilizumab or any elements of DHAOx\n16. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. This condition must be discussed with the patient prior to signing consent and registration in the trial",{"count":699,"type":20},39,[24],"The goal of this clinical trial is to evaluate clinical efficacy of incorporating Epcoritamab into the salvage treatment routine for relapsed-refractory aggressive B-cell lymphoma, followed by autologous stem-cell transplantation (ASCT) and consolidation Epcoritamab. The main questions it aims to answer are:\n\n* Will the addition of epcoritamab to intensive salvage chemotherapy be safe and increase the proportion of patients with relapsed or refractory (R\u002FR) large B-cell lymphoma who achieve a complete remission prior to planned transplant?\n* Is consolidation epcoritamab after ASCT deliverable and safe?\n* Will consolidation epcoritamab will result in improved clearance of molecularly detectable residual disease?\n* Will the combination of pre- and post-ASCT epcoritamab lead to higher rates of progression-free survival (PFS) and event free survival (EFS) at 12 months compared to historical estimates in this population.\n\nParticipants will undergo three phases in this trial:\n\n1. Epcoritamab-Salvage treatment: consists of 3 cycles of R-DHAOx (rituximab, dexamethasone, cytarabine, oxaliplatin) plus Epcoritamab\n2. ASCT: Pre-autograft eligibility assessment for ASCT will be performed according to local practice. ASCT may be administered at local referring centre and will follow local standard operative procedures.\n3. Consolidation treatment: consists of six 28-day cycles of subcutaneous Epcoritamab, commencing 6 - 12 weeks post ASCT.",[184,31,479,703,194,704,705],"DLBCL, Nos Genetic Subtypes","Follicular Large Cell Lymphoma, Relapsed","Follicular Large Cell Lymphoma","2024-07-19",{"date":708,"type":46},"2024-07-22",{"date":710,"type":46},"2023-12-11",{"date":712,"type":20},"2031-11",{"name":714,"class":114},"Australasian Leukaemia and Lymphoma Group",{"id":716,"slug":717,"hasResults":11,"nctId":718,"briefTitle":719,"officialTitle":720,"acronym":4,"eligibilityCriteria":721,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":4,"enrollmentInfo":722,"targetDuration":4,"studyType":220,"phases":4,"briefSummary":723,"conditions":724,"keywords":728,"overallStatus":290,"whyStopped":4,"lastUpdateSubmitDate":730,"lastUpdatePostDateStruct":731,"startDateStruct":733,"completionDateStruct":735,"leadSponsor":737,"locationsCount":140},"100503374","omic-technologies-applied-to-the-study-of-b-cell-lymphoma-for-the-discovery-of-diagnostic-and-prognosis-biomarkers-100503374","NCT05834426","Omic Technologies Applied to the Study of B-cell Lymphoma for the Discovery of Diagnostic and Prognosis Biomarkers","Omic Technologies Applied to the Study of Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma for the Discovery of Diagnostic and Prognosis Biomarkers","Inclusion Criteria:\n\n* 18 years and older;\n* Both sexes;\n* Patients with confirmed histopathological diagnosis of Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma;\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2;\n* Patient intending to receive full-dose treatment (Monoclonal antibodies plus anthracycline based combination chemotherapy);\n* Staged with PET-CT or CT.\n\nExclusion Criteria:\n\n* Patients with comorbidities that may interfere with the interpretation of the results (CKD in dialysis phase, Autoimmune diseases, uncontrolled Diabetes Mellitus (DM), symptomatic Heart Failure (CHF), HIV positive, positive serology for hepatitis B and C);\n* Patients requiring multiple blood transfusions (4 or more blood components for the same period or cause);\n* Pregnant women;\n* First-line treatment in another institution;\n* Diffuse transformed Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma",{"count":503,"type":20},"The goal of this observational study is to determine the plasma metabolomic profile in diffuse large B-cell lymphoma and high-grade B lymphomas patients before, during and after treatment by ultra-high performance liquid chromatography with quadrupole time-of-flight mass spectrometry (UPLC-QTOFMS)",[225,725,726,31,186,317,727],"Neoplasms","Cancer","Metabolomics",[729],"Metabolomic Analysis","2023-06-19",{"date":732,"type":46},"2023-06-22",{"date":734,"type":20},"2023-09-01",{"date":736,"type":20},"2026-08-31",{"name":738,"class":114},"Sociedad de Lucha Contra el Cáncer del Ecuador"]