[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-mediastinal-large-b-cell-lymphoma-pmbcl\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-mediastinal-large-b-cell-lymphoma-pmbcl":70},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,55,83,129,162,194,218,242,270,303,333,365],{"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":63,"enrollmentInfo":64,"targetDuration":4,"studyType":66,"phases":4,"briefSummary":67,"conditions":68,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100467423","bio-car-t-bs-study-100467423","NCT05366569","Bio-CAR-T BS Study","Bio-CAR-T Study on Pre and Post-infusion CAR-T Cell Therapy","Inclusion Criteria:\n\n* Patients with B-cell-ALL (≤ 25 years) or patients with DLBCL (18-70 years) or patients with PMBCL (18-70 years) who were relapsed\u002Frefractory after two lines of treatments;\n* Adequate performance status (0 or 1);\n* Adequate organ function;\n* No active or uncontrolled infections;\n* No thrombo-embolisms within the last 6 months;\n* Absence of clinically relevant co-morbidities (e.g., select cardiovascular, neurologic, or immune disorders with organ dysfunction or requiring immunosuppressive treatment in the last 24 months);\n* Life expectancy of at least 3 months.\n\nExclusion Criteria:\n\n* Patients with B-cell-ALL \\> 25 years\n* Patients with DLBCL \\\u003C18 or \\>70 years\n* Patients with PMBCL \\\u003C18 or \\>70 years\n* Performance status \\> 1;\n* Active or uncontrolled infections;\n* Thrombo-embolisms within the last 6 months;\n* Presence of clinically relevant co-morbidities (e.g., select cardiovascular, neurologic, or immune disorders with organ dysfunction or requiring immunosuppressive treatment in the last 24 months);\n* Life expectancy \\\u003C 3 months.","18 Years","70 Years",{"count":65,"type":20},45,"OBSERVATIONAL","The aim of this Study is the evaluation of post-infusion CAR-T (Chimeric Antigen Receptor T Cell) expansion and persistence in patients with DLBCL, PMBCL and ALL undergoing CAR-T therapy; and the feasibility and efficacy of the treatment in the real life practice.",[69,70,71],"Diffuse Large B Cell Lymphoma (DLBCL)","Primary Mediastinal Large B-cell Lymphoma (PMBCL)","Acute Lymphoblastic Leukemia (ALL)","2026-04-27",{"date":74,"type":46},"2026-04-30",{"date":76,"type":46},"2022-04-26",{"date":78,"type":20},"2026-12-31",{"name":80,"class":81},"Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia","OTHER",1,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":21,"phases":92,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":128},"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":91,"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.",[95,96,97,98,99,100,101,102,103,104,105,31,106,107,108,109,70,110,111,112,113,114,115,116,117,118],"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","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":121,"type":46},"2026-04-14",{"date":123,"type":46},"2024-11-01",{"date":125,"type":20},"2028-12",{"name":127,"class":53},"Verismo Therapeutics",5,{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":16,"minAge":136,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":21,"phases":139,"briefSummary":140,"conditions":141,"keywords":146,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":161},"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":138,"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.",[142,143,144,106,31,70,97,145],"B-Cell Leukemia","Non-Hodgkin's Lymphoma","B-cell Acute Lymphoblastic Leukemia","B-cell Lymphoma",[147,148,149,150,151],"Chimeric Antigen Receptor T cells","CLIC-2201","CD22","Immunotherapy","CAR-T cell","2026-03-30",{"date":154,"type":46},"2026-04-03",{"date":156,"type":46},"2025-01-02",{"date":158,"type":20},"2027-08-01",{"name":160,"class":81},"British Columbia Cancer Agency",7,{"id":163,"slug":164,"hasResults":11,"nctId":165,"briefTitle":166,"officialTitle":167,"acronym":4,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":16,"minAge":169,"maxAge":170,"enrollmentInfo":171,"targetDuration":4,"studyType":21,"phases":173,"briefSummary":174,"conditions":175,"keywords":181,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":193},"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":172,"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.",[144,107,176,177,103,102,97,106,31,178,70,179,180],"Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma","Burkitt Lymphoma","Non Hodgkin Lymphoma","Mixed Phenotype Acute Leukemia",[182,183,184],"CD19-positive","Leukemia","Lymphoma","2026-03-24",{"date":152,"type":46},{"date":188,"type":46},"2025-05-30",{"date":190,"type":20},"2031-09",{"name":192,"class":53},"Vironexis Biotherapeutics Inc.",9,{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":21,"phases":202,"briefSummary":203,"conditions":204,"keywords":207,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":82},"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":138,"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",[205,98,99,102,103,106,70,31,206,97],"Non-hodgkin Lymphoma","Grade 3b Follicular Lymphoma",[208],"Relapsed\u002FRefractory B-cell Lymphoma","2026-03-13",{"date":211,"type":46},"2026-03-16",{"date":213,"type":46},"2023-10-26",{"date":215,"type":20},"2028-01-01",{"name":217,"class":81},"Marcela V. Maus, M.D.,Ph.D.",{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":224,"eligibilityCriteria":225,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":21,"phases":228,"briefSummary":229,"conditions":230,"keywords":232,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":82},"100629322","phase-1-study-of-safety-and-efficacy-of-tc011-in-the-relapsedrefractory-large-b-cell-non-hodgkin-lymphoma-patients-100629322","NCT07473167","Study of Safety and Efficacy of TC011 in the Relapsed\u002FRefractory Large B Cell Non-Hodgkin Lymphoma Patients","A Multi-center, Single Arm, Open-label Phase 1\u002F2 Clinical Trial to Evaluate Safety, and to Explore Efficacy of TC011(CD19 Targeted CAR-T) in the Relapsed\u002FRefractory Large B Cell Non-Hodgkin Lymphoma Patients","TC011","Inclusion Criteria:\n\nSubjects must meet all criteria including:\n\n* ≥19 years old, ECOG 0-2, life expectancy ≥12 weeks\n* Histologically confirmed B-cell lymphoma (WHO 2017)\n* Relapsed\u002Frefractory after ≥2 prior lines of systemic chemotherapy\n* ≥1 measurable lesion (longest diameter ≥1.5 cm)\n* Adequate organ, and pulmonary function\n* LVEF ≥40%\n* Able to undergo leukapheresis\n* For subjects of childbearing potential: agreement to use effective contraception for ≥6 months after TC011 infusion\n\nExclusion Criteria:\n\n* Unresolved ≥Grade 2 toxicities from prior therapy\n* Malignancy within 2 years except specified exceptions\n* Significant cardiac disease within 6 months\n* CNS involvement by lymphoma\n* Active HBV, HCV, HIV, syphilis\n* Rapidly progressing disease per investigator\n* Major surgery requiring general anesthesia within 4 weeks\n* Active or uncontrolled infection\n* Prior therapies such as anti-CD19 agents, adoptive T-cell therapy, gene therapy, allogeneic HSCT\n* Use of other investigational agents, immunosuppressants within protocol-specified windows\n* Pregnancy or breastfeeding\n* Hypersensitivity to study drug components\n* Leukapheresis-specific exclusions (recent chemotherapy, steroids, immunosuppressants)",{"count":227,"type":20},98,[23,24],"This is a multi-center, phase I\u002FII study to determine the safety and efficacy of TC011(CD19 Targeted CAR-T) in adult patients with relapsed or refractory large B-cell non -hodgkin lymphoma.",[27,28,29,231,32,70],"High-grade B-cell Lymphoma (HGBL)",[224,37,39,233],"CLIP","2026-03-10",{"date":211,"type":46},{"date":237,"type":46},"2023-08-03",{"date":239,"type":20},"2028-03-10",{"name":241,"class":53},"TICAROS Co., Ltd.",{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":4,"enrollmentInfo":249,"targetDuration":4,"studyType":21,"phases":251,"briefSummary":252,"conditions":253,"keywords":259,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":54},"100511054","phase-2-pembro-plus-car-t-cell-therapy-in-rr-in-pmbcl-100511054","NCT05934448","Pembro Plus CAR T-cell Therapy in R\u002FR in PMBCL","A Phase II Trial of Pembrolizumab in Combination With Chimeric Antigen Receptor Therapy in Patients With Relapsed\u002FRefractory Primary Mediastinal B-cell Lymphoma","Inclusion Criteria:\n\n* Histologically confirmed diagnosis of PMBCL, EBV+ DLBCL or THRLBCL at one of the participating institutions.\n* Availability of archival or freshly collected tumor tissue before study enrollment. If archival tissue is unavailable or is determined to be inadequate, tumor tissue must be obtained from a biopsy performed at screening, unless an exception is given after consultation with the sponsor-investigator.\n* Eligible for standard of care CAR T-cell therapy with progression after at least two prior lines of therapy OR refractory to initial chemoimmunotherapy OR relapse within 12 months of front-line chemoimmunotherapy OR one prior line of therapy and not fit for HSCT.\n* ECOG Performance Status of 0 or 1.\n* Left ventricular ejection fraction (LVEF) ≥ 50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO).\n* Adequate hematologic function (unless due to underlying disease, as established for example, by extensive bone marrow involvement or due to hypersplenism secondary to the involvement of the spleen by lymphoma per the investigator), defined as follows:\n\n  * ANC ≥ 1,000\u002FμL\n  * Hemoglobin ≥ 8 g\u002FdL\n  * Platelet count ≥ 50,000\u002FμL\n* Participants must have adequate organ as defined below:\n\n  * Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels \\>1.5 × ULN\n  * AST(SGOT)\u002FALT(SGPT) ≤2.5 × ULN (≤5 × ULN for participants with liver involvement)\n  * Adequate renal function defined by serum creatinine ≤1.5 x ULN or creatinine clearance (by Cockcroft-Gault) ≥ 40 ml\u002Fmin for patients with serum creatinine \\>1.5 x ULN\n* At least one bi-dimensionally FDG-avid measurable lymphoma lesion on PET\u002FCT scan, defined as ≥ 1.5 cm in its longest dimension on CT scan, or ≥ 1 cm if extranodal (and measurable).\n* Women of childbearing potential (WOCBP) and men must agree to use effective contraception when sexually active. This applies for the time period between signing of the informed consent form and 6 months for WOCBP and for men after the last administration of study treatment. A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include but are not limited to hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for continuous 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. The investigator or a designated associate is requested to advise the patient how to achieve highly effective birth control, e.g. intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner, use of two forms of birth control, and sexual abstinence. The use of condoms by male patients is required unless the female partner is permanently sterile.\n* Age ≥18 years.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Patients in urgent need of cytoreductive therapy.\n* Participants who are receiving any other investigational agents.\n* History of other malignancies, except:\n\n  * Malignancy treated medically or surgically with curative intent and with no known active disease present for ≥2 years before study registration\n  * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease\n  * Adequately treated carcinoma in situ without evidence of disease.\n  * Localized prostate cancer and low-risk prostate cancer on active surveillance\n  * In the opinion of the treating investigator, there is limited potential to interfere with the safety or efficacy of the investigational regimen. Such exceptions must be approved by the Sponsor-Investigator.\n* Has received a live vaccine within 30 days prior to study registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.\n* Less than 6 months of response to prior PD-L1 inhibitor or PD-1 inhibitor or grade 3 or higher immune-related adverse events.\n* Prior treatment with CAR T-cell therapy.\n* Lactating or pregnant. Women of childbearing potential (WOCBP) must have a negative pregnancy test (urine or serum) at screening. WOCBP will require a negative pregnancy test within 72 hours prior to starting treatment, but eligibility for study enrollment may be confirmed based on testing at screening.\n* Known active lymphomatous involvement of the central nervous system. History of prior CNS involvement is allowed.\n* Recent infection requiring intravenous antibiotics that was completed ≤7 days before the first dose of study drug, or any uncontrolled active systemic infection.\n* Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus infection.\n* History of Human immunodeficiency virus (HIV)-infection.\n* Has received prior radiotherapy within 2 weeks of study registration. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.\n* Has received prior systemic anti-cancer therapy within 2 weeks or investigational agents within 4 weeks.\n* Significant liver disease, such as hepatitis (viral or non-viral) or cirrhosis\n* Prior macrophage activation syndrome (MAS) or hemophagocytic lymphohistiocytosis (HLH)\n* Uncontrolled arrhythmia or Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months of enrollment.\n* Known history of central nervous system or neurologic disease including stroke or intracranial hemorrhage within 3 months prior to enrollment or seizure disorder. Prior CNS involvement with lymphoma is allowed if previously treated with no evidence of involvement at study entry.\n* Prior solid organ or allogeneic stem cell transplant or within 6 weeks of autologous stem cell transplant.\n* Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).\n* Is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to study registration. Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed.\n* Active pneumonitis or interstitial lung disease.\n* Severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients.\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Has not met requirements for standard of care CAR-T therapy",{"count":250,"type":20},35,[24],"This research study is evaluating the combination of drugs, pembrolizumab with chimeric antigen receptor (CAR) T-cell therapy, as a possible treatment for primary mediastinal B-cell lymphoma that has recurred after prior treatment.\n\nThe names of the study drugs involved in this study are:\n\n\\- Pembrolizumab\n\nStandard treatment will include:\n\n* CAR T-cell therapy (either axicabtagene-ciloleucel or lisocabtagene maraleucel)\n* Cyclophosphamide\n* Fludarabine",[70,254,255,256,257,258],"Primary Mediastinal Large B Cell Lymphoma","Primary Mediastinal Large B-Cell Lymphoma Refractory","Primary Mediastinal Large B-Cell Lymphoma Recurrent","Epstein-Barr Virus Positive Diffuse Large B-Cell Lymphoma","T-Cell\u002FHistiocyte-Rich Large B-Cell Lymphoma",[70,254,255,256,258,260],"Epstein-Barr virus-positive diffuse large B-cell lymphoma","2026-03-03",{"date":263,"type":46},"2026-03-05",{"date":265,"type":46},"2023-11-15",{"date":267,"type":20},"2031-06-06",{"name":269,"class":81},"Jennifer Crombie, MD",{"id":271,"slug":272,"hasResults":11,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":276,"eligibilityCriteria":277,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":278,"enrollmentInfo":279,"targetDuration":4,"studyType":21,"phases":281,"briefSummary":282,"conditions":283,"keywords":286,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":302},"100553435","phase-2-a-study-of-wztl-002-car-t-cells-for-adults-with-relapsed-large-b-cell-lymphoma-100553435","NCT06486051","A Study of WZTL-002 CAR T-cells for Adults With Relapsed Large B-cell Lymphoma","A Phase 2 Trial to Evaluate the Efficacy and Safety of WZTL-002 in Patients With Relapsed or Refractory Large B-cell Lymphoma (ENABLE-2)","ENABLE-2","Inclusion Criteria:\n\n1. Age 18 to 75 years (inclusive) at the time of informed consent\n2. Signed written informed consent for this trial\n3. Biopsy-proven relapsed or treatment-refractory B-cell non-Hodgkin lymphoma of the following subtypes, as per the 2022 WHO classification of haematolymphoid tumours\n\n   * Large B-cell lymphomas of the following histological subtypes:\n\n     * Diffuse LBCL, not otherwise specified\n     * Diffuse large B-cell lymphoma\u002Fhigh grade B-cell lymphoma with MYC and BCL2 rearrangements\n     * Large B-cell lymphoma with IRF4 rearrangement\n     * High grade B-cell lymphoma with 11q aberrations\n     * High grade B-cell lymphoma, not otherwise specified\n     * Primary mediastinal large B-cell lymphoma\n     * Follicular large B-cell lymphoma\n     * EBV-positive diffuse large B-cell lymphoma, not otherwise specified\n     * Diffuse large B-cell lymphoma associated with chronic inflammation\n     * Primary cutaneous DLBCL, leg type\n   * Large B-cell lymphoma of one of the above subtypes that has transformed from follicular or marginal zone lymphoma\n4. Received adequate first-line lymphoma therapy for the qualifying histology (as defined in inclusion criterion 3 above), comprising at least 2 cycles of a standard combination regimen incorporating an anthracycline and an anti-CD20 monoclonal antibody\n5. Relapsed or refractory disease meeting one of the following criteria:\n\n   * Relapsed or refractory within 12 months of first-line chemoimmunotherapy, defined as:\n\n     * Progressive disease following ≥ 2 cycles of chemoimmunotherapy, or\n     * Stable disease following ≥ 4 cycles of chemoimmunotherapy, or\n     * Partial response following ≥ 6 cycles of chemoimmunotherapy, or\n     * Complete response followed by biopsy-proven relapse within 12 months of completing first-line chemoimmunotherapy.\n   * Relapsed or refractory following second-line chemoimmunotherapy, defined as:\n\n     * Lack of complete response to, or relapse following, autologous stem cell transplantation as part of second-line therapy for the qualifying histology, or\n     * Inability to proceed to autologous stem cell transplantation due to lack of response to 2 cycles of second-line chemoimmunotherapy incorporating both a platinum agent and an anti-CD20 monoclonal antibody\n6. Positron emission tomography (PET) positive disease according to the Lugano 2014 criteria\n7. Available tumour tissue (comprising a tissue block or at least 6 unstained slides) for central histological review\n8. Lymphoma-related life expectancy at least 12 weeks, and life expectancy related to conditions other than lymphoma at least 12 months\n9. ECOG performance status of 0 or 1\n10. Adequate haematologic function, defined by:\n\n    * Neutrophils ≥ 1.0 × 10\\^9\u002FL, and Platelets ≥ 75 × 10\\^9\u002FL, and\n    * Lymphocytes ≥ 0.3 × 10\\^9\u002FL\n11. Adequate renal function, defined by estimated creatinine clearance (eCrCl) or glomerular filtration rate (eGFR) \\>\u002F= 45mL\u002Fmin using the Cockroft Gault estimation, CKD-EPI equation or as assessed by direct measurement.\n12. Adequate hepatic function, defined by serum bilirubin \\\u003C 2.5 × upper limit of normal (ULN) (unless attributable to Gilbert's syndrome) and alanine transaminase and aspartate aminotransferase \\\u003C 3 × ULN.\n13. Adequate lung function, defined as ≤ Grade 1 dyspnoea according to NCI CTCAE v5.0, and oxygen saturation (sO2) ≥ 92% on room air.\n14. Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) ≥ 40% as assessed by echocardiogram or multigated acquisition (MUGA), performed within 28 days of commencing screening.\n15. For female participants:\n\n    * Agree to use a condom if undertaking sexual activity with any partner during lymphodepleting chemotherapy, and\n    * If of reproductive potential agree to use a highly effective method of contraception from the time of enrolment until at least 12 months after administration of WZTL-002, or\n    * Are not of reproductive potential defined as either,\n\n      * being amenorrhoeic for at least 12 consecutive months with FSH 30 ≥ IU\u002FL, or\n      * previously undergone a sterilisation procedure\n16. For male participants:\n\n    * Agree to use a condom if undertaking sexual activity with any partner during lymphodepleting chemotherapy, and\n    * If undertaking sexual activity with a female partner of reproductive potential agree to use a highly effective method of contraception from the time of enrolment until at least 12 months after administration of WZTL-002, and\n    * Agree not to donate sperm for conception, or to provide gametes for in vitro fertilisation for at least 12 months after administration of WZTL-002\n17. Participant agrees not to donate blood components at any time after receiving WZTL-002\n\nExclusion Criteria:\n\n1. Active central nervous system (CNS) involvement by lymphoma. In patients with a history of CNS disease or a clinical suspicion of current CNS disease, lumbar puncture and MRI brain must be performed within 30 days of enrolment to exclude current CNS involvement.\n2. Active CNS pathology including: epilepsy, seizure within the preceding year, aphasia, paresis, stroke, dementia, psychosis within the preceding year, severe brain injury, Parkinson disease, or cerebellar disease\n3. B-cell non-Hodgkin lymphoma of the following subtypes, as per the 2022 WHO classification of haematolymphoid tumours:\n\n   * Richter transformation of chronic lymphocytic leukaemia\n   * T-cell\u002Fhistiocyte rich LBCL\n   * Primary LBCL of immune-privileged sites\n   * Fluid overload associated LBCL\n   * Fibrin-associated LBCL\n   * Plasmablastic lymphoma\n   * Mediastinal grey zone lymphoma\n   * Intravascular LBCL\n   * ALK-positive large B-cell lymphoma\n   * Lymphomatoid granulomatosis\n   * Burkitt lymphoma\n   * Primary effusion lymphoma\n   * KSHV\u002FHHV8-positive diffuse large B-cell lymphoma\n4. Patient has received 3 or more prior lines of therapy for LBCL, where 1 line of therapy is defined as 1 or more cycles of a combination chemoimmunotherapy with or without pre-planned consolidation therapy (radiotherapy, autologous stem cell transplant or immunotherapy)\n5. Requirement for urgent lymphoma therapy due to tumour-related symptoms, or due to imminent risk of blood vessel, airway, urinary tract, gastrointestinal tract, nerve or spinal cord compression\n6. Active autoimmune disease requiring current systemic immunosuppression\n7. Active sarcoidosis\n8. Prior solid organ transplantation or prior allogeneic stem cell transplantation (allo-SCT)\n9. Peripheral blood CD3+ T cells \\\u003C 150\u002FμL (0.15 x10\\^9\u002FL) as assessed by lymphocyte subset analysis\n10. History of active malignancy other than B-cell malignancy within 2 years prior to enrolment, with the exception of: adequately treated in situ carcinoma of the cervix; adequately treated basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of the skin; other localised malignancy surgically resected (or radically treated with another treatment modality) with curative intent\n11. Prior treatment with:\n\n    * gene therapy (including CAR T-cell therapy) or CD19-targeted immunotherapy, or\n    * purine analogue (including bendamustine) or alemtuzumab within 6 months of enrolment, or\n    * bispecific T-cell engager, radiotherapy or an investigational medicine within 4 weeks of enrolment, or\n    * cytotoxic chemotherapy, systemic corticosteroids (at doses of ≥ 10 mg prednisone daily or equivalent), monoclonal antibody or antibody-drug conjugate (other than alemtuzumab) within 2 weeks of enrolment.\n12. Pregnant or lactating female\n13. Known sensitivity to immunoglobulin or to components of the IP\n14. Current or prior HIV infection\n15. Vaccination with a live virus within the 4 weeks of enrolment\n16. Inadequately-controlled systemic infection\n17. Serologic status reflecting active viral hepatitis B or active hepatitis C infection as follows:\n\n    * Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Patients with presence of HBcAb, but absence of HBsAg, are eligible if hepatitis B virus (HBV) DNA is undetectable (or is \\\u003C 20 IU\u002FmL), and if they are willing to receive appropriate antiviral prophylaxis.\n    * Presence of active Hepatitis C infection as determined by Hepatitis C virus (HCV) RNA detected by PCR or nucleic acid testing (NAT). Patients with presence of HCV antibody, are eligible if HCV RNA is undetectable.\n18. Current New York Heart Association (NYHA) class 2 or higher cardiac symptoms, or myocardial infarction, unstable angina or other clinically significant cardiac disease within the past 6 months\n19. Significant concomitant illnesses which would in the Investigators opinion make the patient an unsuitable candidate for the trial\n20. Patients who have diminished capacity or any circumstance that would prohibit them from understanding and providing informed consent in accordance with ICH-GCP\n21. Patient does not provide consent to enrol to an International Cellular Therapy Registry","75 Years",{"count":280,"type":20},60,[24],"The goal of this clinical trial is to learn if a new type of chimeric antigen receptor (CAR) T-cell therapy called WZTL-002 is effective and safe for the treatment large B-cell lymphomas (LBCL) that have not responded to or have come back after standard chemotherapy. The main questions this trial aims to answer are:\n\n* What is the likelihood of complete response of the lymphoma after WZTL-002 treatment?\n* What is the risk of altered brain function (neurotoxicity) after WZTL-002?\n\nAll eligible participants will receive WZTL-002; the researchers will compare the complete response rate and neurotoxicity rate with historical groups of patients who were treated with similar therapies.\n\nParticipants will:\n\n* Have a procedure to gather white blood cells\n* Receive chemotherapy to prepare for the CAR T-cells\n* Receive WZTL-002 CAR T-cells through a vein\n* Be monitored closely for the first 14 days for certain side effects\n* Have scans 28 days and 3, 6, 12 and 24 months after WZTL-002 CAR T-cells to check if the treatment has worked",[107,284,70,285],"Diffuse Large B-Cell Lymphoma, Not Otherwise Specified","Transformed Non-Hodgkin Lymphoma",[287,288,289,290,291,292,293],"Chimeric Antigen Receptor Therapy","CD19 Antigen","Toll-Like Receptor 2","CD28 Antigen","Relapsed non-Hodgkin Lymphoma","Refractory non-Hodgkin Lymphoma","Adoptive Cellular Immunotherapy","2026-02-27",{"date":261,"type":46},{"date":297,"type":46},"2024-07-12",{"date":299,"type":20},"2028-06-30",{"name":301,"class":81},"Malaghan Institute of Medical Research",3,{"id":304,"slug":305,"hasResults":11,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":310,"enrollmentInfo":311,"targetDuration":4,"studyType":21,"phases":313,"briefSummary":314,"conditions":315,"keywords":320,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":82},"100376822","phase-1-car-2019-t-cells-in-patients-with-relapsed-refractory-b-cell-malignancies-100376822","NCT04186520","CAR-20\u002F19-T Cells in Patients With Relapsed Refractory B Cell Malignancies","Phase I\u002FII Study of Tandem, Bispecific Anti-CD19 Anti-CD20 CAR-T Cells for Patients With Relapsed and\u002For Refractory B Cell Malignancies","GENERAL INCLUSION CRITERIA FOR ALL PATIENTS\n\n1. Patients must be aged ≥18 years and ≤80 years with relapsed or refractory B-cell non-Hodgkin Lymphoma.\n2. Absolute cluster of differentiation 3 (CD3) count ≥50 mm\\^3.\n3. Magnetic resonance imaging (MRI) brain and lumbar puncture with cerebrospinal fluid (CSF) analysis by cytology and flow cytometry without evidence of central nervous system (CNS) involvement ONLY in patients with history of CNS involvement or clinical suspicion at the time of enrollment EXCEPT Arm E subjects.\n4. Measurable disease must be documented within four weeks of the time of consent defined as nodal lesions greater than 15 mm in the long axis or extranodal lesions \\>10 mm in long and short axis OR bone marrow involvement that is biopsy proven for B-cell NHL (see separate criteria for CLL and primary\u002Fsecondary CNS lymphoma).\n5. Karnofsky performance score ≥70.\n6. Adequate hepatic function, defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C5 x upper limit of normal (ULN); serum bilirubin and alkaline phosphatase \\\u003C5 x ULN, or considered not clinically significant as per the clinical PIs discretion (e.g. Gilbert's or indirect hyperbilirubinemia) or felt to be due to underlying disease.\n7. ANC≥1000 with no G-CSF within 72 hours or pegylated G-CSF within 14 days.\n8. Platelets≥50,000 with no transfusion within 72 hours.\n9. Adequate renal function, defined as creatinine clearance \\>60 ml\u002Fmin AND serum Cr≤1.5 mg\u002FdL.\n\n   a. No IV hydration within 24 hours of eligibility. b. No dialysis dependent renal failure within three months of planned CAR infusion.\n10. Able to provide written informed consent.\n11. Agree to practice birth control during the study.\n12. Adequate cardiac function as indicated by New York Heart Association (NYHA) classification I or II AND left ventricular ejection fraction of ≥45% (by cardiac echocardiogram (ECHO) or multigated acquisition scan (MUGA)) and adequate pulmonary function as indicated by room air oxygen saturation of ≥92%.\n13. Expected survival \\>12 weeks.\n14. Negative urine or serum pregnancy test in females of child bearing potential at study entry.\n15. Meet criteria regarding fertility and contraception.\n16. No contraindication to central line access.\n17. Patient has demonstrated compliance to other therapies.\n\nPhase 1: 3+3 COHORT ELEGIBILITY CRITERIA\n\n1. Diagnosis of B-cell NHL including Follicular Lymphoma, Marginal Zone Lymphoma (splenic, nodal, extranodal), Mantle Cell Lymphoma, and DLBCL with associated subtypes (aggressive B-cell lymphoma, high grade B-cell lymphoma, T-cell\u002Fhistocyte rich B-cell lymphoma, primary mediastinal B-cell lymphoma, Epstein-Barr virus-positive (EBV+) diffuse large B-cell lymphoma, transformed lymphoma such as transformed follicular or marginal zone, and Richter's transformation).\n2. Patients must have active, measurable disease as defined and meet one of the following criteria.\n\n   1. Must have received Rituximab or another cluster of differentiation 20 (CD20) antibody and at minimum two different chemotherapy regimens appropriate for their disease and be ineligible to receive autologous transplant.\n   2. Relapse post-autologous transplant\n   3. Relapse post-allogeneic transplant\n   4. Patients not previously treated with CAR-T cell therapy\n\nPHASE 1b and 2 COHORT ELEGIBILITY CRITERIA\n\nARM A: Six to nine patient expansion with 8-day manufacturing (Phase 1b)\n\n1. Diagnosis of B-cell NHL including Follicular Lymphoma, Marginal Zone Lymphoma (splenic, nodal, extranodal), and DLBCL with associated subtypes (aggressive B-cell lymphoma, T-cell\u002Fhistocyte rich B-cell lymphoma, primary mediastinal B-cell lymphoma, EBV+ diffuse large B-cell lymphoma, transformed lymphoma such as transformed follicular or marginal zone, and Richter's transformation).\n2. Patients must have active, measurable disease as defined and meet one of the following criteria:\n\n   1. Must have received Rituximab or another cluster of differentiation 20 (CD20) antibody and at minimum two different chemotherapy regimens appropriate for their disease and be ineligible to receive autologous transplant.\n   2. Relapse post-autologous transplant.\n   3. Relapse post-allogeneic transplant.\n   4. Relapse post-anti-cluster of differentiation 19 (CD19) CAR-T cell therapy.\n\n   i. A maximum of two patients with prior CAR-T will be allowed in this cohort.\n\nARM B: Six to nine patient expansion with 12-day manufacturing (Phase 1b)\n\n1\\. Diagnosis of B-cell NHL including Follicular Lymphoma, Marginal Zone Lymphoma (splenic, nodal, extranodal), and DLBCL with associated subtypes (aggressive B-cell lymphoma, high grade B-cell lymphoma, T-cell\u002Fhistocyte rich B-cell lymphoma, primary mediastinal B-cell lymphoma, EBV+ diffuse large B-cell lymphoma, transformed lymphoma such as transformed follicular or marginal zone, and Richter's transformation).\n\n2\\. Patients must have active, measurable disease as defined and meet one of the following criteria:\n\n1. Must have received Rituximab or another CD20 antibody and at minimum two different chemotherapy regimens appropriate for their disease and be ineligible to receive autologous transplant.\n2. Relapse post-autologous transplant.\n3. Relapse post-allogeneic transplant.\n4. Relapse post-anti-CD19 CAR-T cell therapy.\n\ni. A maximum of two patients with prior CAR-T will be allowed in this cohort.\n\nARM C: 24 patient cryopreservation 8\u002F12 flexible manufacturing arm\n\n1. Diagnosis of B-cell NHL including Follicular Lymphoma, Marginal Zone Lymphoma (splenic, nodal, extranodal), and DLBCL with associated subtypes (aggressive B-cell lymphoma, high grade B-cell lymphoma, T-cell\u002Fhistocyte rich B-cell lymphoma, primary mediastinal B-cell lymphoma, EBV+ diffuse large B-cell lymphoma, transformed lymphoma such as transformed follicular or marginal zone, and Richter's transformation).\n2. Patients must have active, measurable disease as defined and meet one of the following criteria a. Must have received Rituximab or another CD20 antibody and at minimum two different chemotherapy regimens appropriate for their disease and be ineligible to receive autologous transplant b. Relapse post-autologous transplant c. Relapse post-allogeneic transplant d. Relapse post-anti-CD19 CAR-T cell therapy i. A maximum of 2 patients with prior CAR-T will be allowed in this cohort\n\nARM D: Phase 1 and Phase 1b: CLL\n\n1\\. Diagnosis of B-cell CLL or small lymphocytic leukemia (SLL) 2. Failed\u002Fprogressed or been intolerant to two prior lines of therapy one of which MUST be either a covalent BTK inhibitor (e.g. ibrutinib, acalabrutinib, zanabrutinib, etc) or BCL2 inhibitors (e.g. venetoclax or other investigational BCL2) 3. Indication for treatment as defined as any of the following:\n\n1. measurable lymph nodes ≥ 1.5 cm in the greatest transverse diameter and\u002For hepatomegaly or splenomegaly)\n2. bone marrow involvement with ≥10% CLL involvement\n\nARM E: Phase 1 and Phase1b Relapsed\u002FRefractory Primary or Secondary CNS Lymphoma\n\n1. Diagnosis of diffuse large B cell lymphoma (DLBCL) with associated subtypes (aggressive B-cell lymphoma, high grade B-cell lymphoma, T-cell\u002Fhistocyte rich B-cell lymphoma, primary mediastinal B-cell lymphoma, EBV+ diffuse large B-cell lymphoma, transformed lymphoma such as transformed follicular or marginal zone, and Richter's transformation) with secondary CNS lymphoma involvement OR primary CNS lymphoma.\n2. For Primary CNS lymphoma, relapsed or refractory following at least one line of CNS-directed therapy.\n3. Secondary CNS lymphoma relapsed or refractory following at least one line of CNS-directed therapy for treatment of CNS lymphoma.\n\n   1. For patients with secondary central nervous system lymphoma (CNSL) with concurrent systemic lymphoma, the concurrent systemic lymphoma must have relapsed following at least 1 prior line of therapy (which must have included an anti-CD20 monoclonal antibody and an anthracycline)\n4. Measurable CNS disease by either lumbar puncture (LP) with positivity in CNS by flow cytometry or morphology for lymphoma cells OR magnetic resonance imaging (MRI) with enhancing lesions ≥1 cm in size consistent with lymphoma\n5. Must have had prior treatment with high dose methotrexate defined as methotrexate given intravenously at a dose ≥2500 mg\u002Fm\\^2 and either progression\u002Frelapse, stable disease, or intolerance to at least one cycle of treatment.\n\nPhase II Cohort: Mantle Cell Lymphoma\n\n1\\. Diagnosis of Mantle Cell Lymphoma. 2. Patients must have active, measurable disease as previously defined and have relapsed, refractory disease as defined as one of the following:\n\n1. Relapsed disease after two lines of cytotoxic chemotherapy including administration of anti-CD20 antibody.\n2. Progressive disease after ≥second line Bruton tyrosine kinase (BTK) inhibitor.\n3. Relapse post-autologous transplant.\n4. Relapse post-allogeneic transplant.\n5. Relapse post anti-CD19 CAR-T cell therapy.\n\ni. A maximum of four patients with history of prior anti-CD19 CAR-T will be allowed in this cohort.\n\nEXCLUSION CRITERIA (ALL PATIENTS)\n\nA potential subject who meets any of the following exclusion criteria is ineligible to participate in the study.\n\n1. Positive beta- human chorionic gonadotropin (HCG) in female of childbearing potential.\n2. Confirmed active human immunodeficiency virus (HIV), Hepatitis B or C infection.\n3. History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon requiring steroid therapy defined as \\>20 mg of prednisone or equivalent daily.\n4. Presence of ≥grade 3 non-hematologic toxicities as per CTCAE version 5.0 from any previous treatment unless it is felt to be due to underlying disease.\n5. Concurrent use of investigational therapeutic agents or enrollment on another therapeutic clinical trial at any institution. Minimum of 14 days or 5 half-lives of the drug (whichever is shorter) washout prior to apheresis.\n6. Refusal to participate in the long-term follow-up protocol\n7. Patients with active CNS involvement by malignancy on MRI or by lumbar puncture (Not applicable to Arm E cohort.)\n\n   a. Patients with prior CNS disease that has been effectively treated will be eligible providing treatment was \\>4 weeks before enrollment and a remission documented within 8 weeks of planned CAR-T cell infusion by MRI brain and CSF analysis.\n8. Previous recipients of allogeneic hematopoietic stem cell transplantation (AHCT) are excluded if they are \\\u003C100 days' post-transplant, have evidence of active graft-versus-host-disease (GVHD) of any grade, or are currently on immunosuppression.\n9. Prior allogeneic CAR T-cell therapy\n10. Previous recipients of autologous CAR-T cell therapy directed at either CD19 or CD20 are excluded if they are \\\u003C100 days post prior CAR-T cell treatment (does not include re-enrollment) or have \\>5% residual circulating CAR-T as measured by flow cytometry using a CD19 CAR detection reagent (Miltenyi Biotec)\n\n    a. Patients with prior CAR-T treatment against CD19 or CD20 must have repeat biopsy post-CAR-T cell therapy confirming a minimum of 5% CD19 or CD20 positivity by immunohistochemistry or flow cytometry\n11. Anti-CD20 antibody treatment within 4 weeks of cell infusion\n12. Anti-CD19 antibody treatment within 4 weeks of cell infusion\n13. Cytotoxic chemotherapy other than lymphodepletion within 14 days of CAR-T cell infusion\n14. Cytotoxic chemotherapy treatment within 14 days or steroid treatment (other than replacement dose steroids) within 7 days prior to apheresis collection for CAR-T cells\n15. Oral chemotherapeutic agents or antibody directed treatment within 7 days of apheresis\n\n    a. BTK inhibitors are allowed until 1-day prior to apheresis and can re-start until 1-day prior to lymphodepletion\n16. Patients post solid organ transplant who develop high grade lymphomas or leukemias\n17. Concurrent active malignancy other than basal or squamous cell carcinomas of the skin (underlying low-grade lymphoma chronic lymphocytic leukemia\u002Ffollicular lymphoma (FL)\u002Fmarginal zone lymphoma (MZL) is allowable in patients with transformed large cell lymphoma)\n\nSPECIAL CRITERIA REGARDING FERTILITY AND CONTRACEPTION\n\nFemale subjects of reproductive potential (women who have reached menarche or women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within the preceding 24 months, or have not undergone a sterilization procedure \\[hysterectomy or bilateral oophorectomy\\]) must have a negative serum or urine pregnancy test performed as part of eligibility criteria Due to the high-risk level of this study, while enrolled, all subjects must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization). Additionally, if participating in sexual activity that could lead to pregnancy, the study subject must agree to use reliable and double barrier methods of contraception during the follow-up period of the protocol.\n\nAcceptable birth control includes a combination of two of the following methods:\n\n* Condoms (male or female) with or without a spermicidal agent.\n* Diaphragm or cervical cap with spermicide\n* Intrauterine device (IUD)\n* Hormonal-based contraception Subjects who are not of reproductive potential (women who are premenarche or have been post-menopausal for at least 24 consecutive months or have undergone hysterectomy tubal ligation, salpingectomy, and\u002For bilateral oophorectomy or men who have documented azoospermia) are eligible without requiring the use of contraception","80 Years",{"count":312,"type":20},100,[23,24],"This is a Phase I\u002FII, interventional, single-arm, open-label, treatment study designed to evaluate the safety and efficacy of Interleukin-7 and Interleukin-15 (IL-7\u002FIL-15) manufactured chimeric antigen receptor (CAR)-20\u002F19-T cells as well as the feasibility of a flexible manufacturing schema in adult patients with B cell malignancies that have failed prior therapies.",[316,317,318,102,103,106,70,319],"Non Hodgkin Lymphoma (NHL)","Mantle Cell Lymphoma (MCL)","Chronic Lymphocytic Leukemia (CLL)","Central Nervous System Lymphoma",[37,321,322,323],"Chimeric antigen receptor T-cell therapy","CAR Therapy","B-cell Malignancies","2026-02-19",{"date":326,"type":46},"2026-02-23",{"date":328,"type":46},"2020-05-18",{"date":330,"type":20},"2029-02-28",{"name":332,"class":81},"Medical College of Wisconsin",{"id":334,"slug":335,"hasResults":11,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":4,"eligibilityCriteria":339,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":340,"enrollmentInfo":341,"targetDuration":4,"studyType":21,"phases":343,"briefSummary":345,"conditions":346,"keywords":348,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":364},"100511026","lifestyles-implemented-survivorship-care-plan-in-lymphoma-survivors-100511026","NCT05934084","Lifestyles Implemented-Survivorship Care Plan In Lymphoma Survivors","Lifestyles Implemented-Survivorship Care Plan In Lymphoma Survivors: A Randomized Non-pharmacological Clinical Trial By The Fondazione Italiana Linfomi (FIL)","Inclusion Criteria:\n\n* Age 18-50 at initial treatment;\n* Diagnosis of classical Hodgkin lymphoma (cHL), Diffuse Large B-cell lymphoma (DLBCL) or Primary mediastinal large B-cell lymphoma (PMBCL);\n* Patients in Complete Remission (CR) after first-line therapy \\[ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) or BEACOPP (bleomycin, etoposide, doxorubicin , cyclophosphamide, vincristine, procarbazine and prednisone) or ABVD-BEACOPP Pet-2 guided treatment for cHL; R-CHOP (rituximab-cyclophosphamide, doxorubicin, vincristine and prednisone) for DLBCL; R-CHOP or R-DA-EPOCH (rituximab- Dose Adapted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin) for PMBCL);\n* Patients in remission for a minimum 3 years since the last treatment and a maximum of 10 years;\n* Cumulative doxorubicin\u002F adriamycin dose received of at least 200 mg\u002Fmq (4 cycles of chemotherapy);\n* Availability echocardiogram (ECG) and 2D-STE-echocardiography (Two-dimensional speckle strain echocardiography) performed no later than three months prior to enrollment;\n* Signature of a written informed consent form indicating that the patient understands the purpose of and procedures required for the study and is willing to participate voluntarily in the study.\n\nExclusion Criteria:\n\n* Diagnosis of secondary cancer at baseline, except non-melanoma skin cancers and adequately treated cone-biopsied in situ carcinoma of the cervix;\n* Second line chemotherapy of stem cell transplant;\n* Not able to perform physical activity;\n* Grade \\>\u002F=3 neuropathy;\n* Vertebral fractures or stenosis of the vertebral canal; other bone fracture;\n* Cardiovascular disease: arrhythmia \\>\u002F= grade 2, hypertension \\>\u002F grade 2, left ventricular dysfunction \\>\u002F= grade 2 pericardial disease\u002Feffusion any grade, myocarditis any grade, pulmonary hypertension any grade, restrictive cardiomyopathy any grade valvular hearth disease \\>\u002F= grade 2, right ventricular dysfunction \\>\u002F= grade 2;\n* Venous thromboembolism or arterial thrombosis during last 6 months;\n* Hemorrhage\u002F bleeding \\>\u002F= grade 2 during last 6 months;\n* Chronic lymphedema (arms and\u002F or limbs);\n* Rheumatic disease or inflammatory bowel disease in systemic treatment;\n* Any pleural effusion;\n* If female, the patient is pregnant;\n* Unwilling to comply to all required visits and procedures for the duration of study participation","50 Years",{"count":342,"type":20},552,[344],"NA","This is a prospective randomized open-label, multicenter, 2-arm study to assess the role of healthy LifeStyle implemented Survivorship Care Plan (LS-SCP) in modifying the Quality of Life (QoL) in a population of long-term lymphoma survivors (in remission for a minimum 3 years since the last treatment and a maximum of 10 years).",[347,69,70],"Classical Hodgkin Lymphoma",[349,350,351,352,353,354],"Survivorship Care Plan","Lifestyles implemented-Survivorship Care Plan","Quality of Life","Lymphoma Survivors","Nutritional plan","Physical activity","2026-01-09",{"date":357,"type":46},"2026-01-12",{"date":359,"type":46},"2024-02-26",{"date":361,"type":20},"2026-02-01",{"name":363,"class":81},"Fondazione Italiana Linfomi - ETS",40,{"id":366,"slug":367,"hasResults":11,"nctId":368,"briefTitle":369,"officialTitle":370,"acronym":371,"eligibilityCriteria":372,"healthyVolunteers":11,"sex":16,"minAge":62,"maxAge":4,"enrollmentInfo":373,"targetDuration":4,"studyType":66,"phases":4,"briefSummary":375,"conditions":376,"keywords":378,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":82},"100542160","italian-observational-study-on-car-t-therapy-for-lymphoma-100542160","NCT06339255","Italian Observational Study on CAR-T Therapy for Lymphoma","A Multicenter Prospective Observational Study on Chimeric Antigen Receptor (CAR) T-cell Therapy for Lymphoma: Monitoring Feasibility, Efficacy, Toxicity and Biomarkers in a Real Life Setting","CART-SIE","Inclusion Criteria:\n\n* Patients with diagnosis of DLCBL, PMBCL, MCL and FL eligible for CAR-T treatment with commercialy available products in Italy.\n\nExclusion Criteria:\n\n* Not applicable",{"count":374,"type":20},5300,"The goal of this observational study on chimeric antigen receptor T-cell therapy is to monitor the feasibility, efficacy, toxicity and biomarkers in a real life setting.\n\nPartecipants will be asked to agree to their clinical data collection and to partecipate to the optional biological study that aims to evaluate biomarkers of toxicity and response (clinical characteristics, cytokine profile, cellcomposition and type of the CAR-T cell product, lymphoma genomics). The study will evaluate even the disease response according to lugano criteria by PET and CT in routine clinical activity.",[377,70,97,102],"Diffuse Low Grade B-Cell Lymphoma",[37,184],"2024-03-24",{"date":381,"type":46},"2024-04-01",{"date":383,"type":46},"2019-10-30",{"date":385,"type":20},"2029-12-31",{"name":387,"class":81},"Paolo Corradini"]