[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diffuse-large-b-cell-lymphoma-dlbcl\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diffuse-large-b-cell-lymphoma-dlbcl":188},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,61,0,25,[9,41,72,110,141,176,202,227,253,282,312,338,364,397,425,445,469,495,521,545,566,589,617,638,661],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100054229","phase-2-a-study-of-glofitamab-plus-gemox-compared-with-standard-of-care-in-patients-with-relapsedrefractory-diffuse-large-b-cell-lymphoma-100054229",false,"NCT07599423","A Study of Glofitamab Plus GemOx Compared With Standard of Care in Patients With Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma","An Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Glofitamab in Combination With Gemcitabine Plus Oxaliplatin Versus Standard of Care in Patients With Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma","Inclusion Criteria:\n\n* Signed Informed Consent Form.\n* Age 18 years or older at the time of signing the Informed Consent Form.\n* Histologically proven diffuse large B-cell lymphoma (DLBCL), including transformation from follicular lymphoma.\n* Relapsed or refractory disease after first-line chemoimmunotherapy, defined as refractory disease (no complete remission to first-line therapy, progressive disease as best response, stable disease after 3-4 cycles, or partial response after 6-8 cycles\u002Fprogression within 12 months of first-line therapy) or relapsed disease (complete remission followed by biopsy-proven relapse within 12 months of first-line therapy).\n* No known history or suspicion of central nervous system (CNS) involvement by lymphoma.\n* Life expectancy of at least 12 weeks.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* At least one bi-dimensionally measurable nodal lesion (1.5 cm or larger) or extranodal lesion (1 cm or larger) as measured on a CT scan.\n* Negative HIV test at screening.\n* Adequate hematologic function defined as hemoglobin 9.0 g\u002FdL or higher without transfusion in the past 7 days, absolute neutrophil count 1.0 x 10\\^9\u002FL or higher, and platelet count 75 x 10\\^9\u002FL or higher.\n* Adequate organ function defined as estimated creatinine clearance 60 mL\u002Fmin or higher, ALT\u002FAST 2.5 times the upper limit of normal (ULN) or lower, and total bilirubin 1.5 mg\u002FdL or lower (or 3 x ULN or lower in subjects with Gilbert's syndrome).\n* Cardiac ejection fraction greater than 50%, no evidence of pericardial effusion, and no clinically significant electrocardiogram findings.\n* No clinically significant pleural effusion.\n* Baseline oxygen saturation greater than 92% on room air.\n* Able to understand and complete study-related questionnaires.\n* Agreement to remain abstinent or use adequate contraceptive methods for both female and male participants during the treatment period and for the protocol-specified duration after the final dose.\n\nExclusion Criteria:\n\n* Contraindication to glofitamab components or a history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.\n* Not eligible for autologous stem cell transplantation (ASCT).\n* Prior solid organ transplantation.\n* History of Richter's transformation or of indolent disease to diffuse large B-cell lymphoma (DLBCL) or primary mediastinal B-cell lymphoma (PMBCL).\n* Peripheral neuropathy assessed to be greater than Grade 1 at enrollment.\n* Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3.\n* Use of any investigational therapy for treating cancer within 28 days prior to Cycle 1, any monoclonal antibody within 3 months, or systemic immunotherapeutic agents within 4 weeks or five half-lives (whichever is shorter).\n* Prior radiotherapy to the mediastinal or pericardial region.\n* History of autologous or allogeneic stem cell transplant.\n* Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 or better, except for alopecia and anorexia.\n* Administration of a live, attenuated vaccine within 4 weeks before the first study treatment administration.\n* Received more than one line of therapy for DLBCL.\n* Corticosteroid use greater than 50 mg\u002Fday of prednisone or equivalent for purposes other than lymphoma symptom control.\n* Recent major surgery within 4 weeks before the first study treatment.\n* History of other malignancy that could affect compliance or interpretation of results, with exceptions for adequately treated low-grade or in situ carcinomas and malignancies in remission for at least 2 years.\n* Significant cardiovascular disease, such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 3 months, unstable arrhythmias, or unstable angina.\n* Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, neurodegenerative disease, or CNS lymphoma.\n* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH).\n* Current or past history of Waldenstrom macroglobulinemia.\n* History or presence of a clinically significant abnormal ECG.\n* Known or suspected active infection, reactivation of a latent infection, or any major episode of infection requiring hospitalization or IV antibiotics within 4 weeks of dosing.\n* History of severe treatment-emergent immune-related adverse events associated with prior immunotherapeutic agents.\n* History of autoimmune disease, with specific protocol-defined exceptions for well-controlled conditions.\n* Clinically significant liver disease, including active viral\u002Fother hepatitis or cirrhosis.\n* Abnormal coagulation laboratory values defined as INR or PT greater than 1.5 x ULN, or PTT\u002FaPTT greater than 1.5 x ULN.\n* Suspected active or latent tuberculosis.\n* Positive test results for chronic hepatitis B infection (HBsAg positive) or positive test results for hepatitis C with positive HCV RNA.\n* Diagnosis with SARS-CoV-2 infection within 30 days prior to first study treatment, or documented infection within 6 months with persistent respiratory symptoms.\n* History of progressive multifocal leukoencephalopathy (PML).\n* Pregnancy, breastfeeding, or intention of becoming pregnant during the study.","ALL","18 Years",{"count":20,"type":21},96,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The purpose of this study is to evaluate the efficacy and safety of glofitamab in combination with gemcitabine plus oxaliplatin (GemOx) versus standard of care (SOC) in patients with relapsed\u002Frefractory diffuse large B-cell lymphoma (R\u002FR DLBCL) who have relapsed early (within 1 year) or are primary refractory to first-line therapy. Participants will be randomly assigned in a 1:1 ratio to receive either the Glofitamab-GemOx combination regimen or SOC. The SOC arm consists of investigator's choice of salvage chemoimmunotherapy followed by autologous stem cell transplantation (ASCT) for eligible patients. The primary endpoint of the study is event-free survival (EFS).",[27],"Diffuse Large B Cell Lymphoma (DLBCL)","NOT_YET_RECRUITING","2026-07-10",{"date":31,"type":32},"2026-07-13","ACTUAL",{"date":34,"type":21},"2026-07-22",{"date":36,"type":21},"2030-12-31",{"name":38,"class":39},"The First Affiliated Hospital of Soochow University","OTHER",1,{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":51,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":61,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":40},"100053791","registry-platform-hematologic-malignancies-rubin---extension-of-tumor-registry-lymphatic-neoplasms-100053791","NCT06043011","Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms","Clinical Research Platform on Treatment, Quality of Life and Outcome of Patients With Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms","RUBIN","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Confirmed diagnosis of the respective NHL\n* If patient is alive: signed written informed consent\n\n  * For patients participating in the PRO survey: IC prior to or at day of start of respective line of treatment.\n  * For patients not participating in the PRO survey: IC latest eight weeks after start of respective line of treatment.\n\nExclusion Criteria:\n\n* No systemic therapy for respective lymphoid malignancy.",{"count":50,"type":21},2950,"5 Years","OBSERVATIONAL","The purpose of the project is to set up a national, prospective, longitudinal, multicenter registry platform to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with hematological malignancies in Germany.",[55,56,57,58,59,60],"Chronic Lymphocytic Leukemia (CLL)","Diffuse Large B-cell Lymphoma (DLBCL)","Follicular Lymphoma (FL)","Mantle Cell Lymphoma (MCL)","Marginal Zone Lymphoma (MZL)","Waldenström's Macroglobulinemia (WM)",[62],"non-Hodgkin lymphoma (NHL)","RECRUITING",{"date":31,"type":32},{"date":66,"type":32},"2023-09-27",{"date":68,"type":21},"2033-12",{"name":70,"class":71},"iOMEDICO AG","INDUSTRY",{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":83,"conditions":84,"keywords":89,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":109},"100449326","phase-1-a-study-of-nx-5948-in-adults-with-relapsedrefractory-b-cell-malignancies-100449326","NCT05131022","A Study of NX-5948 in Adults With Relapsed\u002FRefractory B-cell Malignancies","A Phase 1, Dose Escalation, and Cohort Expansion Study Evaluating NX-5948, a Bruton's Tyrosine Kinase (BTK) Degrader, in Adults With Relapsed\u002FRefractory B-cell Malignancies","Key Inclusion Criteria:\n\n* Age ≥18 years\n* Patients in Phase 1a (Dose Escalation) must have histologically confirmed R\u002FR CLL, SLL, DLBCL (subgroups include Richter-transformed DLBCL, germinal center B-cell type, activated B-cell type, high-grade B-cell lymphoma with MYC and BCL-2 and\u002For BCL-6 rearrangements, high-grade B-cell lymphomas NOS), FL, MCL, MZL (subtypes include EMZL, MALT, NMZL, SMZL), WM, or PCNSL.\n* Patients in Phase 1a must meet the following:\n\n  o For non-PCNSL indications, received at least 2 prior lines of therapy and have no other available therapies known to provide clinical benefit. For PCNSL, received at least 1 prior line of therapy\n* Patients in Phase 1b (Safety and Cohort Expansion) must have 1 of the following histologically documented B-cell malignancies, must meet criteria for systemic treatment, and must have received prior therapies and\u002For molecular features based on details described for each cohort: CLL or SLL, DLBCL, MCL, FL, MZL, WM, or PCNSL\u002FSCNSL.\n* Measurable disease per response criteria specific to the malignancy.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (0-2 for patients with PCNSL and secondary CNS involvement).\n* Adequate organ and bone marrow function\n\nKey Exclusion Criteria:\n\n* Known or suspected active prolymphocytic leukemia or Richter's transformation to Hodgkin's lymphoma prior to study enrollment\n* Prior treatment for the indication under study for anti-cancer intent that includes:\n\n  1. Radiotherapy within 2 weeks of planned start of study drug (excluding limited palliative radiation).\n  2. Prior systemic chemotherapy within 2 weeks of planned start of study drug.\n  3. Prior monoclonal antibody therapy within 4 weeks of planned start of study drug, except for patients enrolling in Cohort 16 (CLL with secondary wAIHA) where a 16-week washout period is required.\n  4. Prior small molecule therapy within 2 weeks or 5 half-lives (whichever is shorter) of planned start of study drug.\n  5. Autologous or allogeneic stem cell transplant within 100 days prior to planned start of study drug.\n  6. Chimeric antigen receptor (CAR) T-cell therapy within 100 days prior to start of study drug (within 60 days prior to start of study drug for Phase 1b).\n  7. Use of systemic corticosteroids outside of dosing limits described below and within 7 days prior to initiation of study treatment excepting those used as prophylaxis for radio diagnostic contrast. Patients with PCNSL\u002FSCNSL: no greater than 40 mg\u002Fday prednisone, or equivalent. Patients with PCNSL\u002FSCNSL using greater than 20 mg\u002Fday prednisone, or equivalent, must be clinically stable at that dose for 7 days. All other diagnoses: no greater than 20 mg\u002Fday prednisone or equivalent.\n  8. Use of systemic immunosuppressive drugs other than systemic corticosteroids for any medical condition within 60 days prior to first dose of study drug\n  9. Previously treated with a BTK degrader\n* Active, uncontrolled autoimmune hemolytic anemia (except for patients enrolling in Cohort 16) or active, uncontrolled autoimmune thrombocytopenia.\n* Patient has any of the following within 6 months of planned start of study drug:\n\n  1. Myocardial infarction, unstable angina, unstable symptomatic ischemic heart disease, or placement of a coronary arterial stent\n  2. Uncontrolled atrial fibrillation or other clinically significant arrhythmias, conduction abnormalities, or New York Heart Association (NYHA) class III or IV heart failure\n  3. Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), stroke, or intracranial hemorrhage\n  4. Any other significant cardiac condition (e.g., pericardial effusion, restrictive cardiomyopathy, severe untreated valvular stenosis, severe congenital heart disease, or persistent uncontrolled hypertension defined as systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg despite optimal medical management)\n* Bleeding diathesis, or other known risk for acute blood loss.\n* History of Grade ≥ 2 hemorrhage within 28 days of planned start of study drug.\n* Active known concurrent malignancy or malignancy other than the one under study within the past 3 years. (Exceptions include, but are not limited to, patients with more recent history of basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast may enroll if they have undergone curative therapy and have no evidence of disease).",{"count":80,"type":21},572,[82],"PHASE1","This is a first-in-human Phase 1a\u002F1b multicenter, open-label study designed to evaluate the safety and anti-cancer activity of NX-5948 in patients with advanced B-cell malignancies.",[55,85,27,57,58,59,86,87,88],"Small Lymphocytic Lymphoma (SLL)","Waldenstrom Macroglobulinemia (WM)","Primary Central Nervous System Lymphoma (PCNSL)","Secondary Central Nervous System Lymphoma (SCNSL)",[90,91,92,93,94,95,96,97,98,99],"BTK Degrader","BTK Inhibitor","B-Cell Malignancy","Lymphoma","C481","C481S","Bruton's Tyrosine Kinase","NX-5948","Targeted Protein Degradation","Chimeric Targeting Molecule (CTM)","2026-06-30",{"date":102,"type":32},"2026-07-02",{"date":104,"type":32},"2022-04-13",{"date":106,"type":21},"2028-01",{"name":108,"class":71},"Nurix Therapeutics, Inc.",62,{"id":111,"slug":112,"hasResults":12,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":120,"conditions":121,"keywords":126,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":40},"100629759","phase-1-radiation-oral-vancomycin-and-car-t-for-b-cell-lymphomas-100629759","NCT07478848","Radiation, Oral Vancomycin, and CAR-T for B-Cell Lymphomas","A Pilot Trial of Bridging Radiation Therapy With Oral Vancomycin for Patients With B-cell Lymphomas Undergoing CAR-T Therapy","Inclusion Criteria:\n\n* Male or female subject aged ≥ 18 years.\n* Pathologically confirmed B-cell lymphoma patients intended for standard of care CAR-T\n* ECOG Performance Status ≤ 2.\n* Subjects must be clinically eligible to receive standard of care anti-CD19 CAR-T\n* Subjects must have at least one site of disease amenable to radiation, with the ability to deliver radiation to at least 50% of involved sites\n* Subjects must have at least one site of measurable disease based on CT or FDG PET\n* Subjects must not be anticipated to require additional therapy beyond bridging radiation listed in this protocol for control of their lymphoma\n* For female subjects: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause.\n\nThe following age-specific requirements apply:\n\nWomen \\\u003C 50 years of age: amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).\n\nWomen ≥ 50 years of age: amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or had radiation-induced menopause with last menses \\>1 year ago; or had chemotherapy-induced menopause with last menses \\>1 year ago; or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).\n\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n\nExclusion Criteria:\n\n* Unable to take oral vancomycin for any reason, including: Allergy or Inability to swallow drug\n* Known history of vancomycin resistant enterococcus (VRE)\n* Contraindications to radiation therapy, including scleroderma, systemic lupus erythematosus, Crohn disease, ulcerative colitis, or idiopathic pulmonary fibrosis\n* History of radiation pneumonitis or other grade 4 radiation-related adverse event\n* Prior or concurrent malignancy whose natural history or treatment which has the potential to interfere with the safety or efficacy assessment of the radiation therapy are eligible for this trial.\n* Severe, uncontrolled, significant intercurrent or recent illness that would exclude them from being a candidate for standard-of-care CART therapy.\n* Known uncontrolled HIV infection with a detectable viral load at the time of screening. Note: Patients on effective antiretroviral therapy or who will plan on going on antiretroviral therapy at the time of screening are eligible for this trial. HIV testing is not required for eligibility.\n* Active infection that required the use of antibiotics within 4 weeks prior to registration\n* Any other condition that would, in the investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures",{"count":118,"type":21},14,[82],"This clinical trial assesses whether it is feasible to use radiation therapy with vancomycin prior to CAR T-cell therapy for patients with large B-cell lymphomas",[122,123,27,124,125],"Large B Cell Lymphoma","Non Hodgkin Lymphoma (NHL)","Diffuse Large B Cell Lymphoma Refractory","Diffuse Large B Cell Lymphoma Relapsed",[127,128,129,130,131],"non-hodgkin lymphoma","NHL","large B cell lymphoma","DLBCL","diffuse large B cell lymphoma","2026-06-29",{"date":134,"type":32},"2026-07-01",{"date":136,"type":32},"2026-05-29",{"date":138,"type":21},"2029-01-01",{"name":140,"class":39},"Abramson Cancer Center at Penn Medicine",{"id":142,"slug":143,"hasResults":12,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":12,"sex":17,"minAge":148,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":22,"phases":151,"briefSummary":152,"conditions":153,"keywords":160,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":168,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":175},"100426707","phase-1-study-of-efficacy-and-safety-of-crc01-in-adult-large-b-cell-lymphoma-and-b-cell-acute-lymphoblastic-leukemia-patients-100426707","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.","19 Years",{"count":150,"type":21},91,[82,24],"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.",[154,155,56,156,157,158,159],"Relapsed Large B-cell Lymphoma","Refractory Large B-cell Lymphoma","Primary Mediastinal Large B-Cell Lymphoma (PMBCL)","High-grade B-cell Lymphoma","Transformed Follicular Lymphoma (TFL)","ALL (Acute B-Lymphoblastic Leukemia)",[161,162,163,164,165,166,167],"CRC01","anti-CD19 CAR-T","CAR-T","CAR T cells","Chimeric antigen receptor","PD-1 knock down","TIGIT knock down",{"date":134,"type":32},{"date":170,"type":32},"2021-03-02",{"date":172,"type":21},"2030-09-26",{"name":174,"class":71},"Curocell Inc.",2,{"id":177,"slug":178,"hasResults":12,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":186,"conditions":187,"keywords":189,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":40},"100643890","glofitamab-combined-with-selinexor-in-patients-with-relapsedrefractory-diffuse-large-b-cell-lymphoma-100643890","NCT07669194","Glofitamab Combined With Selinexor in Patients With Relapsed\u002FRefractory Diffuse Large B-cell Lymphoma","Observational Real-World Study of Glofitamab Combined With Selinexor for Patients With Relapsed\u002FRefractory Diffuse Large B-cell Lymphoma (R\u002FR DLBCL)","Glofit-Sel","Inclusion Criteria:\n\n* Age 18 years and older at the time of informed consent.\n* Histologically confirmed CD20+ diffuse large B-cell lymphoma (DLBCL).\n* Relapsed or refractory disease, having previously received at least two lines of systemic therapy.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.\n* Presence of measurable disease.\n* Adequate hematologic, hepatic, and renal function.\n* Willingness to use effective contraception methods during the study and for a specified period after the last dose.\n* Willing and able to provide written informed consent and comply with the study protocol.\n\nExclusion Criteria:\n\n* Prior treatment with any CD20\u002FCD3 bispecific antibodies or XPO1 inhibitors.\n* Current or prior history of central nervous system (CNS) involvement by lymphoma or other significant CNS diseases.\n* Active and uncontrolled systemic infections, including known HIV infection, active Hepatitis B virus (HBV), or active Hepatitis C virus (HCV) infection.\n* Active autoimmune diseases requiring systemic immunosuppressive therapy.\n* Clinically significant, severe, or uncontrolled cardiovascular diseases.\n* Other active invasive malignancies within the past 2 years (with exceptions for adequately treated localized cancers).\n* Recent major surgery or receipt of live attenuated vaccines within a specified timeframe prior to the study.\n* Severe gastrointestinal conditions that may significantly affect the absorption of oral medications.\n* Known severe allergic reactions to any of the study drugs or their excipients.\n* Pregnant or breastfeeding women.",{"count":185,"type":21},30,"Assess the efficacy and safety of glofitamab in combination with selinexor for the treatment of relapsed or refractory diffuse large B-cell lymphoma (R\u002FR DLBCL) in patients who have received at least two prior lines of systemic therapy.",[188],"Diffuse Large B-Cell Lymphoma (DLBCL)",[190,191,192],"Relapsed\u002FRefractory","Glofitamab","Selinexor","2026-06-22",{"date":195,"type":32},"2026-06-25",{"date":197,"type":21},"2026-06-10",{"date":199,"type":21},"2029-04-30",{"name":201,"class":39},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":203,"slug":204,"hasResults":12,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":12,"sex":17,"minAge":210,"maxAge":211,"enrollmentInfo":212,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":214,"conditions":215,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":226},"100641676","neurocognitive-assessment-in-long-term-survivors-of-lymphoma-100641676","NCT07652476","Neurocognitive Assessment in Long-Term Survivors of Lymphoma","Neurocognitive Assessment in Long-Term Survivors of Lymphoma: An Observational Study by the Fondazione Italiana Linfomi (FIL)","FIL_LymDeCo","Inclusion Criteria:\n\n* Patients with previous diagnosis of classic Hodgkin Lymphoma (cHL) or Diffuse Large B Cell Lymphoma (DLBCL) or Primary Mediastinal B Cell Lymphoma (PMBCL).\n* Patients in complete remission after first line anthracycline containing regimen (ABVD, BV-AVD, BEACOPP, R-CHOP, Pola-R-CHP o R-DA-EPOCH) +\u002F- radiotherapy.\n* Age ≥ 25 and ≤ 55 at enrollment.\n* Patients between third and fifth year of follow-up after the end of the first line treatment.\n* Absence of signs or symptoms of disease relapse.\n\nExclusion Criteria:\n\n* Patients with CNS disease localization.\n* Patients that received brain\u002Fneuroaxis radiotherapy.\n* Pre-existing severe psychiatric or neurologic comorbidities influencing neurocognitive assessment.","25 Years","55 Years",{"count":213,"type":21},100,"This is an observational, multicenter, prospective cohort study including patients treated for lymphoma in Italian real-life. Patients eligible for the enrollment in the study will be consecutively included in Italian FIL centers. Patients will be evaluated once during regular follow-up, in the absence of clinical or radiologic signs of disease relapse.\n\nThe assessment of neurocognitive functioning will be performed through a panel of tests, both self-administered and individually administered (about 1 hour). The administration of these neuropsychological tests should be done according to a standardized and predefined order. If available, according to local practice, a neuropsychologist may be involved in test administration and in the evaluation of the results.\n\nBased on its observational nature, no treatment change or modification or additional exams or visits will be required because of being enrolled in this study.",[216,27,217],"Classic Hodgkin Lymphoma","Primary Mediastinal B Cell Lymphoma","2026-06-17",{"date":193,"type":32},{"date":221,"type":21},"2026-09",{"date":223,"type":21},"2028-03",{"name":225,"class":39},"Fondazione Italiana Linfomi - ETS",7,{"id":228,"slug":229,"hasResults":12,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":22,"phases":236,"briefSummary":237,"conditions":238,"keywords":240,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":40},"100641249","phase-2-the-cardioprotect-trial-100641249","NCT07654426","The CARDIOPROTECT Trial","A Randomized Study of Dexrazoxane or Liposomal Doxorubicin in Newly Diagnosed Diffuse Large B-cell Lymphoma at High Risk for Heart Failure Events: the CARDIOPROTECT Trial","Inclusion Criteria:\n\n* Participants must have histologically confirmed diffuse large B-cell lymphoma, histologically transformed large B cell lymphoma from a prior indolent lymphoma, or other high-grade B-cell lymphoma for which R-CHOP or pola-R-CHP are planned. Any cancer stage is permitted.\n* Participants must not have received any prior chemotherapy for this malignancy. Pre-phase steroids are allowed. Prior treatment for a different malignancy is allowed, including prior treatment for indolent lymphoma.\n* Age ≥18 years. Diffuse large B cell lymphoma is rare in participants \\\u003C18 years of age. The prevalence of HF prior to chemotherapy is also exceedingly rare in participants \\\u003C18 years of age; therefore, participants \\\u003C18 years of age are excluded from this study.\n* Participants must have ONE or more of the following risk factors for HF events with anthracycline-containing chemotherapy\n\n  1. LVEF 30-50% on most recent echocardiogram with or without HF history\n  2. LVEF 50% with a history of HF (i.e. HF with improved EF or HF with preserved EF).\n  3. History of anthracycline exposure for different malignancy.\n* Participants 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* Because dexrazoxane as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. 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 treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of chemotherapy administration.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* New York Heart Association (NYHA) Class III or IV exertional dyspnea. The symptoms should be attributed to HF and not due to lymphoma, anemia, arthritis or other causes per the assessment of the treating clinician or study investigator. NYHA Class III defined as: \"Marked limitations with less than ordinary activity such as walking short distances or climbing a few stairs\" and NYHA Class IV defined as: \"Inability to carry out any activity without discomfort. Symptoms are present at rest and if any physical activity is undertaken the symptoms are increased.\" (see Appendix A for NYHA Classification).\n* LVEF \\\u003C30% on most recent echocardiogram. Patients with prior LVEF \\\u003C30% with improvement to \\>30% on most recent echocardiogram are eligible.\n* Meeting criteria for frailty according to the simplified geriatric assessment (see Appendix A for the simplified geriatric assessment criteria).\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in study.\n* Presence of central nervous system involvement\n* Presence of concurrent genetic rearrangements of the MYC and BCL2 genes, so called \"double-hit\" large-cell lymphoma who are not deemed eligible for intensified induction chemotherapy such as dose adjusted EPOCH-R by their treating physician can be enrolled\n* Ineligible for R-CHOP or pola-R-CHP because of liver disease per institutional policies\n* Patients with planned dose reductions from the first cycle ie R-mini-CHOP will be excluded\n* There are no contraindicated medications. Caution and monitoring are advised with medications that can cause myelosuppression.\n* Patients with positive Hepatitis B core antibody can be enrolled if they have negative viral load and can be maintained on antiviral prophylaxis\n* Patients with HIV can be enrolled if they have anti-retroviral therapy options without drug-drug interactions with the cancer treatment, agree to take anti-retroviral therapy and do not have uncontrolled opportunistic infections.\n* Pregnant women are excluded from this study because dexrazoxane and liposomal doxorubicin are agents 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 dexrazoxane and liposomal doxorubicin, breastfeeding should be discontinued if the mother is treated with dexrazoxane and liposomal doxorubicin. These potential risks may also apply to other agents used in this study.\n* Eligibility for observational arm of the study. The above inclusion and exclusion criteria are for the randomized trial. Patients who meet the inclusion criteria but have one or more exclusion criterion are eligible to participate in the observational arm of the study. In addition, patients who meet all eligibility criteria for the randomized trial but decline participation in the randomized trial are also eligible to participate in the observational arm of the study.",{"count":235,"type":21},60,[24],"This trial is to evaluate if dexrazoxane is safer and more effective than liposomal doxorubicin in preventing heart failure events in participants with diffuse large B-cell lymphoma (DLBCL) undergoing either standard of care R-CHOP or pola-R-CHP treatment regiments.\n\nThe names of the study drugs involved in this study are:\n\n* Dexrazoxane (a type of Topoisomerase II Inhibitor)\n* Liposomal Doxorubicin (a type of Topoisomerase II Inhibitor)\n* Standard of care R-CHOP treatment regimen (Cyclophosphamide, doxorubicin, vincristine, prednisone, rituximab)\n* Standard of care pola-R-CHP treatment regimen: Cyclophosphamide, doxorubicin, polatuzumab vedotin-piiq, prednisone, rituximab",[56,239,93],"Cardiotoxicity",[56,241,239,93,242,243,244],"High Risk for Heart Failure Events","Stage B Heart Failure","Stage C Heart Failure","Left ventricular ejection fraction (LVEF) decline","2026-06-12",{"date":218,"type":32},{"date":248,"type":21},"2026-10-02",{"date":250,"type":21},"2035-12-31",{"name":252,"class":39},"Beth Israel Deaconess Medical Center",{"id":254,"slug":255,"hasResults":12,"nctId":256,"briefTitle":257,"officialTitle":258,"acronym":259,"eligibilityCriteria":260,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":261,"targetDuration":4,"studyType":22,"phases":263,"briefSummary":265,"conditions":266,"keywords":267,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":281},"100523149","phase-3-a-study-to-compare-how-well-odronextamab-combined-with-chemotherapy-works-and-how-safe-it-is-against-rituximab-combined-with-chemotherapy-in-adult-patients-with-previously-untreated-diffuse-large-b-cell-lymphoma-100523149","NCT06091865","A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Adult Patients With Previously Untreated Diffuse Large B-cell Lymphoma","A Phase 3, Open Label, Randomized Study Comparing the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 × Anti-CD3 Bispecific Antibody, in Combination With CHOP (ODRO-CHOP) Versus Rituximab in Combination With CHOP (R-CHOP) in Previously Untreated Participants With Diffuse Large B-cell Lymphoma (DLBCL) (OLYMPIA-3)","OLYMPIA-3","Key Inclusion Criteria:\n\n1. Previously untreated participants for lymphoma with documented Cluster of Differentiation 20+ (CD20+) DLBCL, as described in the protocol OR relapsed or refractory DLBCL, for whom next available standard of care therapy is not available or deemed ineligible according to the investigator (Part 1A only)\n2. Measurable disease with at least one nodal lesion or at least one extranodal lesion, as described in the protocol\n3. Eastern Cooperative Oncology Group (ECOG) performance status ≤2\n4. Life expectancy ≥ 12 months\n5. International Prognostic Index (IPI) of 3 to 5 (part 1 only) and ≥2 (part 2) for untreated DLBCL only\n6. Adequate hematologic and organ function, as defined in the protocol.\n\nKey Exclusion Criteria:\n\n1. Primary Central Nervous System (CNS) lymphoma or known involvement by non-primary CNS NHL and history or current relevant CNS pathology\n2. Another active malignancy, significant active disease or medical condition, as described in the protocol\n3. Peripheral neuropathy Grade ≥3\n4. Treatment with any systemic anti-lymphoma therapy, except for participants with Relapsed\u002FRefractory (R\u002FR) DLBCL and participants with DLBCL transformed from an indolent lymphoma after treatment with systemic anti-lymphoma therapy.\n5. Any other therapy or investigational treatment within 28 days or 5 half-lives of the drug, whichever is shorter, prior to the start of study treatment\n6. Recent major surgery, prior organ transplantation, or standard radiotherapy, as described in the protocol\n7. Allergy\u002Fhypersensitivity to study drugs, as described in the protocol\n8. Infections such as any active infection (bacterial, viral, fungal, mycobacterial, parasitic or other), active Coronavirus Disease (COVID-19) infection, uncontrolled infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV), Cytomegalovirus (CMV) infection, as described in the protocol.\n\nNote: Other protocol-defined Inclusion\u002F Exclusion criteria apply",{"count":262,"type":21},904,[264],"PHASE3","This study is researching an experimental drug called odronextamab, referred to as study drug, when used in combination with chemotherapy. The study is focused on patients with Diffuse Large B-cell Lymphoma (DLBCL) that have not been treated before (called \"previously untreated\"). Patients with DLBCL that have come back after treatment (called \"relapsed\"), or have not responded to treatment (called \"refractory\"), can also participate in this study.\n\nThis study will be made up of Part 1A, Part 1B, and Part 2.The aim of Part 1A and Part 1B of the study is to see how safe and tolerable the study drug in combination with chemotherapy is and to determine the dose and schedule of the study drug to be combined with chemotherapy in Part 2 of the study.\n\nThe aim of Part 2 of the study is to see how effective the combination of the study drug with chemotherapy is in comparison with the combination of rituximab (the comparator drug), and chemotherapy, the current standard of care treatment approved for DLBCL. Standard of care means the usual medication expected and used when receiving treatment for a condition.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug when combined with chemotherapy\n* How much study drug is in the blood at different times\n* Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)\n* The impact from the study drug on quality of life and ability to complete routine daily activities",[56],[268,269,270,271,272],"Non-Hodgkin Lymphomas (NHL)","B-cell Non-Hodgkin Lymphomas (B-NHL)","Diffuse Large B-cell Lymphoma","Odronextamab","Anti-CD20 × anti-CD3 bispecific antibody",{"date":274,"type":32},"2026-06-15",{"date":276,"type":32},"2023-12-13",{"date":278,"type":21},"2029-09-12",{"name":280,"class":71},"Regeneron Pharmaceuticals",155,{"id":283,"slug":284,"hasResults":12,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":289,"targetDuration":4,"studyType":22,"phases":291,"briefSummary":292,"conditions":293,"keywords":298,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":303,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":311},"100591414","phase-1-dose-determining-study-of-exs73565-in-participants-with-relapsed-or-refractory-b-cell-malignancies-100591414","NCT06980116","Dose Determining Study of EXS73565 in Participants With Relapsed or Refractory B-Cell Malignancies","A Phase 1 Open-label, Multicenter, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of EXS73565 in Participants With Relapsed or Refractory B-cell Malignancies","Key Inclusion Criteria:\n\n* Age ≥18 years at the time of signing the informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Histologically confirmed diagnosis of one of the following B-cell malignancies: chronic lymphocytic leukemia (CLL), including Richter's transformation from CLL, mantle-cell lymphoma, diffuse large B-cell lymphoma, follicular lymphoma, marginal zone lymphoma, or waldenström macroglobulinaemia.\n* Participants that have relapsed after standard of care or have progressed during standard of care or are not suitable for standard of care therapy\n\nKey Exclusion Criteria:\n\n* Any medical or psychiatric condition that, in the view of the Principal Investigator, could jeopardize or would compromise the participant's safety or ability to participate in the study.\n* Known central nervous system (CNS) malignancy or primary CNS lymphoma.\n* Concurrent active or previous malignancy (other than the primary lymphoma\u002FCLL for which the participant will be treated on this protocol within 5 years prior to randomization; participants with prior cancers may be enrolled with documented Sponsor approval.\n* Received anticancer therapy, including chemotherapy, immunotherapy, radiation therapy (with the exception of palliative radiotherapy), biologic therapy, cancer-related hormonal therapy, or any investigational therapy within 14 days or 5 half-lives (whichever is shorter) before the first dose of the study treatment.",{"count":290,"type":21},85,[82],"The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of EXS73565 administered orally as a single agent in participants with relapsed\u002Frefractory B-cell malignancies.",[294,295,57,59,58,296,297],"Relapsed or Refractory B-cell Malignancies","Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL)","Diffuse-large B-cell Lymphoma (DLBCL)","Waldenstrom's Macroglobulinemia (WM)",[299,300,57,59,58,296,297,301],"B-cell Malignancies","Chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma (CLL\u002FSLL)","MALT1","2026-06-09",{"date":304,"type":32},"2026-06-11",{"date":306,"type":32},"2025-03-31",{"date":308,"type":21},"2028-12",{"name":310,"class":71},"Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.",9,{"id":313,"slug":314,"hasResults":12,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":4,"eligibilityCriteria":318,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":319,"targetDuration":4,"studyType":22,"phases":321,"briefSummary":322,"conditions":323,"keywords":326,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":332,"completionDateStruct":334,"leadSponsor":336,"locationsCount":4},"100642551","phase-1-a-study-of-rocbrutinib-in-combination-with-lacutoclax-in-patients-with-b-cell-malignancies-100642551","NCT07609862","A Study of Rocbrutinib in Combination With Lacutoclax in Patients With B-Cell Malignancies","A Phase Ib\u002FII, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BTK Inhibitor Rocbrutinib in Combination With BCL-2 Inhibitor Lacutoclax in Patients With B-Cell Malignancies","Inclusion Criteria:\n\n1. Age ≥18 years, regardless of sex.\n2. Ib: Histologically confirmed diagnosis of CLL\u002FSLL (per 2018 iwCLL criteria) or B-cell malignancies (per 2022 WHO classification), including: MCL, DLBCL, FL, and WM. Must have received at least one prior line of systemic therapy, with documented disease progression or intolerance.\n\n   II: For Treatment-naïve (TN) CLL\u002FSLL patients: Must meet iwCLL treatment indications and no prior systemic therapy. For R\u002FR CLL\u002FSLL patients: at least one prior systemic therapy with documented disease progression or intolerance.\n3. Have at least one measurable lesion.\n4. Phase Ib: ECOG performance status ≤1; phase II: ECOG performance status ≤2.\n5. Life expectancy ≥ 12 weeks.\n6. Adequate coagulation function, liver and kidney function, bone marrow hematopoietic function.\n7. Male patients and female patients of childbearing potential must agree to use effective contraception during the study and for 90 days after the last dose of study treatment. Female patients of childbearing potential must have a negative pregnancy test before study treatment and must not be breastfeeding. Male patients must not donate sperm during the study and for 90 days after the last dose.\n8. Participation is voluntary, requiring signed informed consent and compliance with the treatment regimen and visit schedule.\n\nExclusion Criteria:\n\n1. Known hypersensitivity or intolerance to Rocbrutinib, Lacutoclax, or any of their excipients; prior treatment with any BCL-2 inhibitor; or prior treatment with both covalent and non-covalent BTK inhibitors.\n2. Use of systemic corticosteroids at doses equivalent to \\>20 mg\u002Fday of prednisone for ≥3 days within 7 days prior to the first dose.\n3. History of or currently suspected Richter's syndrome.\n4. Known or suspected central nervous system (CNS) involvement.\n5. Prior allogeneic hematopoietic stem cell transplantation (allo-HSCT), or autologous hematopoietic stem cell transplantation (auto-HSCT) or chimeric antigen receptor T-cell (CAR-T) therapy within 90 days before the first dose of study treatment.\n6. Received antitumor therapy, investigational agents, major surgery, severe trauma, or live attenuated vaccines within 4 weeks or 5 half-lives prior to the first dose of study treatment.\n7. Received herbal medicines for antitumor treatment, or localized radiotherapy within 14 days prior to the first dose of study treatment.\n8. Use of moderate or strong CYP3A inhibitors within 7 days prior to the first dose of study treatment, or consumption of grapefruit, grapefruit juice, starfruit, or Seville oranges within 3 days prior to prior to the first dose.\n9. History of other active malignancies within the past 3 years, except for curatively treated basal cell carcinoma, localized squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or other malignancies considered cured.\n10. Any severe and\u002For uncontrolled systemic disease, or any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in the study.\n11. Any of the following events within 6 months prior to the first dose: Symptomatic arrhythmia, myocardial infarction, intracranial hemorrhage, or Stroke.\n12. Impaired cardiac function.\n13. Any uncontrolled systemic infection.\n14. Conditions that may impair oral drug administration or significantly affect absorption or pharmacokinetics of the study drug.\n15. Unable to discontinue moderate or strong CYP3A inhibitors or inducers, P-gp (P-glycoprotein) inhibitors, sensitive substrates of OATP1B3 or CYP2C8 during the study period.\n16. Received vaccination with any live-attenuated vaccines within 4 weeks prior to the first dose of study treatment.\n17. Evidence of an active bleeding constitution or a history of significant hemorrhagic disorders.\n18. Requirement for ongoing therapy with warfarin or other vitamin K antagonists.\n19. Presence of an active, uncontrolled, or symptomatic autoimmune disease that requires systemic treatment.\n20. Any other condition that, in the investigator's judgment, makes the patient unsuitable for study participation.",{"count":320,"type":21},92,[82,24],"BTK inhibitors and BCL-2 inhibitors have demonstrated significant clinical activity in mature B-cell malignancies, and combination therapy may provide improved clinical benefit. This is a multi-center, open-label, single-arm Phase Ib\u002FII clinical study. The purpose of this clinical trial is to investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of Rocbrutinib, a fourth-generation Bruton tyrosine kinase inhibitor (BTKi), in combination with the BCL-2 inhibitor Lacutoclax in patients with mature B-cell malignancies. The Phase Ib will use a classic 3+3 dose-escalation design to evaluate dose-limiting toxicities (DLTs), determine the maximum tolerated dose (MTD), and identify the recommended dosing regimen. The Phase II portion is intended to further evaluate the efficacy and safety of the combination therapy.",[58,188,324,325,295],"Follicular Lymphoma ( FL)","Waldenström Macroglobulinemia (WM)",[327,328,329],"mature B-cell malignancies","BTK inhibitor","BCL-2 inhibitor","2026-06-07",{"date":197,"type":32},{"date":333,"type":21},"2026-05-30",{"date":335,"type":21},"2033-05-30",{"name":337,"class":71},"Guangzhou Lupeng Pharmaceutical Company LTD.",{"id":339,"slug":340,"hasResults":12,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":4,"eligibilityCriteria":344,"healthyVolunteers":12,"sex":17,"minAge":345,"maxAge":4,"enrollmentInfo":346,"targetDuration":4,"studyType":22,"phases":348,"briefSummary":349,"conditions":350,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":40},"100642651","phase-1-axatilimab--car-t-for-high-risk-lymphoma-100642651","NCT07638982","Axatilimab + CAR-T for High-Risk Lymphoma","An Open-label, Phase I Trial, With an Expansion Cohort: Macrophage Conditioning to Synergize With CAR-T in High-risk Lymphoma (MAC-SHIFT)","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Histologically confirmed large B-cell lymphoma\n* Presence of one or more high-risk features\n* Eligible to receive CAR-T according to the FDA label\n* Measurable disease by CT or PET\n* Adequate organ function unless related to lymphoma involvement:\n* Pulse oximetry ≥ 92% on room air\n* Ejection Fraction ≥ 40%\n* ALT\u002FAST \\\u003C 5x ULN\n* Bilirubin \\\u003C 3 x ULN\n* Calculated or measured creatinine Clearance ≥ 30 mL\u002Fmin\n\nExclusion Criteria:\n\n* KPS \\\u003C60\n* Second malignancy with a high metastatic potential within 3 years\n* Active CNS involvement. Treated CNS disease is allowed\n* Active HBV or HCV infection.\n* Active uncontrolled infections\n* Known HIV positive status\n* Allogeneic transplant within 100 days of enrollment\n* Active acute or chronic graft versus host disease\n* History of acute or chronic pancreatitis\n* History of myositis","8 Years",{"count":347,"type":21},29,[82],"Axatilimab + CAR-T in High-Risk Lymphoma",[27,351,352,353,354,355],"Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma","High-grade B-cell Lymphoma (HGBCL)","High-Grade B-Cell Lymphoma, Nos","PMBCL","Follicular Grade 3 Lymphoma","2026-06-05",{"date":197,"type":32},{"date":359,"type":21},"2026-10-31",{"date":361,"type":21},"2029-12-31",{"name":363,"class":39},"Northside Hospital, Inc.",{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":370,"eligibilityCriteria":371,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":372,"targetDuration":4,"studyType":22,"phases":374,"briefSummary":375,"conditions":376,"keywords":383,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":396},"100607438","phase-3-a-study-to-investigate-ronde-cel-versus-investigators-choice-cd19-car-t-cell-therapy-100607438","NCT07188558","A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy","A Phase 3 Randomized Controlled Trial of Rondecabtagene Autoleucel , an Autologous, Dual-targeting CD19\u002FCD20 CAR T-Cell Product Candidate, Vs. Investigator's Choice of CD19 CAR T-Cell Therapy in Patients With Relapsed or Refractory Large B-Cell Lymphoma in the Second-line Setting","PiNACLE-H2H","Key Inclusion Criteria:\n\n1. CAR T cell naïve and eligible to receive a CD19 CART-cell therapy\n2. Histologically confirmed large B-cell lymphoma, including the following types defined by (WHO 2022) or International Consensus Classification (2022)\n\n   * Diffuse large B-cell lymphoma (DLBCL)\n   * Transformations of indolent B-cell lymphomas (excluding Richter's transformation)\n   * DLBCL\u002FHigh-grade B-cell lymphoma (HGBCL) with MYC and BCL2 rearrangements\n   * High-grade B-cell lymphoma (HGBCL) not otherwise specified (HGBCL NOS)\n   * Primary mediastinal large B-cell lymphoma (PMBCL)\n   * Grade 3B follicular lymphoma\u002Flarge cell follicular lymphoma (FL3B)\n3. Relapsed or refractory disease after anti-CD20 antibody and anthracycline-containing first-line chemoimmunotherapy\n4. Measurable disease by presence of \\[18F\\]-fluorodeoxyglucose PET\u002FCT positive lesion during Screening per Lugano Criteria\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n6. Adequate hematological, renal, hepatic, pulmonary, and cardiac function\n\nKey Exclusion Criteria:\n\n1. Patients ineligible to receive CD19 CAR T-cell therapy\n2. Primary CNS lymphoma\n3. Patients with primary cutaneous LBCL, human herpes virus-8 positive lymphoma, Burkitt lymphoma, T cell histiocyte-rich lymphoma, or transformation from chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma (Richter's transformation)\n4. Patients with prior history of malignancy, other than aggressive relapsed or refractory LBCL, unless the patient has been free of the disease for ≥ 2 years\n5. Patients with uncontrolled systemic fungal, bacterial, viral, or other infection (including tuberculosis) despite appropriate antibiotics or other treatment\n6. Active autoimmune disease requiring ongoing systemic immunosuppressive therapy.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply",{"count":373,"type":21},400,[264],"This Phase 3 study compares rondecabtagene autoleucel (ronde-cel), a dual-targeting CD19\u002FCD20 CAR T-cell therapy, with investigator's choice of CD19 CAR T-cell therapy in patients with relapsed or refractory large B-cell lymphoma in the second-line setting.",[377,378,379,380,381,382,27,124,125],"Large B-cell Lymphoma","Lymphoma, B-Cell","Relapsed Non-Hodgkin Lymphoma","Refractory Non-Hodgkin Lymphoma","Non-Hodgkin Lymphoma","Non-Hodgkin Lymphoma Refractory\u002F Relapsed",[93,381,384,385,386,377],"CAR T-Cell Therapy","CD19","CD19\u002FCD20","2026-06-04",{"date":389,"type":32},"2026-06-08",{"date":391,"type":32},"2026-01-12",{"date":393,"type":21},"2032-01",{"name":395,"class":71},"Lyell Immunopharma, Inc.",38,{"id":398,"slug":399,"hasResults":12,"nctId":400,"briefTitle":401,"officialTitle":402,"acronym":4,"eligibilityCriteria":403,"healthyVolunteers":12,"sex":17,"minAge":404,"maxAge":405,"enrollmentInfo":406,"targetDuration":4,"studyType":22,"phases":408,"briefSummary":409,"conditions":410,"keywords":412,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":418,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":422,"locationsCount":424},"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":407,"type":21},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).",[27,411],"High Grade B Cell Lymphoma",[191,413,414,415,416,417],"Polatuzumab","Obinutuzumab","Rituximab","Cyclophosphamide","Doxorubicin",{"date":356,"type":32},{"date":420,"type":32},"2025-01-16",{"date":106,"type":21},{"name":423,"class":39},"Memorial Sloan Kettering Cancer Center",8,{"id":426,"slug":427,"hasResults":12,"nctId":428,"briefTitle":429,"officialTitle":429,"acronym":430,"eligibilityCriteria":431,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":432,"targetDuration":4,"studyType":22,"phases":434,"briefSummary":435,"conditions":436,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":438,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":443,"locationsCount":40},"100640126","phase-2-efficacy-and-safety-of-polatuzumab-vedotin-in-combination-with-zanubrutinib-rituximab-cyclophosphamide-doxorubicin-and-prednisone-in-patients-with-previously-untreated-diffuse-large-b-cell-lymphoma-of-the-mcdbn2n1-subtypes-100640126","NCT07608978","Efficacy and Safety of Polatuzumab Vedotin in Combination With Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in Patients With Previously Untreated Diffuse Large B-Cell Lymphoma of the MCD\u002FBN2\u002FN1 Subtypes","Pola-ZRCHP","Inclusion Criteria:\n\n* Age ≥18 years at the time of signing informed consent. Histologically confirmed Diffuse Large B-Cell Lymphoma (DLBCL) with MCD\u002FBN2\u002FN1 molecular subtypes defined by LymphGen classification.\n\nPreviously untreated (treatment-naïve). International Prognostic Index (IPI) score of 2-5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. Life expectancy ≥6 months. At least one measurable lesion in two dimensions, defined as a maximum diameter \\>1.5 cm by CT or MRI.\n\nLeft Ventricular Ejection Fraction (LVEF) ≥50% as assessed by echocardiogram (ECHO).\n\nAdequate hematologic function (unless due to underlying disease, e.g., extensive bone marrow involvement, or splenomegaly secondary to splenic involvement deemed by the investigator to be caused by DLBCL; blood product transfusions are allowed), defined as follows:\n\nHemoglobin ≥9.0 g\u002FdL within 7 days prior to first treatment, without packed RBC transfusion.\n\nAbsolute Neutrophil Count (ANC) ≥1.0 × 10⁹\u002FL. Platelet count ≥75 × 10⁹\u002FL. Female participants of childbearing potential: Must agree to abstain from heterosexual intercourse or use contraception, and agree not to donate ova.\n\nMale participants: Must agree to abstain from heterosexual intercourse or use contraception, and agree not to donate sperm.\n\nExclusion Criteria:\n\nContraindication to any component of the Pola-ZRCHP regimen. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding onychomycosis) at screening, or any major infection occurring within 4 weeks prior to the first dose of study treatment (as judged by the investigator).\n\nSuspected or latent tuberculosis (confirmed by positive IFNγ release assay). Currently pregnant or breastfeeding, or planning a pregnancy during the study period or within 12 months after the last dose.\n\nHistory of confirmed Progressive Multifocal Leukoencephalopathy (PML). Current or history of Central Nervous System (CNS) lymphoma. Evidence of significant, uncontrolled concomitant disease that may affect compliance with the protocol or interpretation of results.\n\nSevere or extensive cardiovascular disease, such as New York Heart Association (NYHA) Class III or IV, or objective assessment of Class C or D cardiac disease; myocardial infarction within the past 6 months; unstable arrhythmias; or unstable angina.\n\nClinically significant liver disease, including active viral hepatitis or other hepatitis, current alcohol abuse, or cirrhosis.\n\nAny of the following abnormal laboratory values (unless these abnormalities are solely attributable to underlying lymphoma):\n\nINR or PT \\>1.5 × Upper Limit of Normal (ULN) in the absence of therapeutic anticoagulation.\n\nPTT or aPTT \\>1.5 × ULN in the absence of lupus anticoagulant. Serum AST and ALT ≥2.5 × ULN. Total bilirubin ≥1.5 × ULN. Estimated creatinine clearance \\\u003C40 mL\u002Fmin (using the Cockcroft-Gault formula). Positive HBV DNA test result. Positive Hepatitis C test result (Hepatitis C virus \\[HCV\\] antibody serology). Note:Patients with positive HCV antibody are eligible only if the PCR test for HCV RNA is negative.\n\nAny other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that gives reasonable suspicion of a disease or condition that contraindicates the use of the investigational drug(s).",{"count":433,"type":21},35,[24],"This is a prospective, open-label, single-arm, single-center, Phase II clinical study designed to evaluate the efficacy and safety of Efficacy and Safety of Polatuzumab Vedotin in Combination With Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in Patients With Previously Untreated Diffuse Large B-Cell Lymphoma of the MCD\u002FBN2\u002FN1 Subtypes.\n\nAfter successful screening, enrolled patients will receive 6 treatment cycles (21 days per cycle). Disease response will be assessed by CT\u002FPET-CT during treatment and after completion of induction. Patients who achieve CR\u002FPR\u002FSD will proceed to the maintenance phase; patients who do not achieve at least SD (i.e., fail to reach CR\u002FPR\u002FSD) during induction will discontinue the study. Patients with CR\u002FPR\u002FSD after induction will receive maintenance therapy with zanubrutinib plus tislelizumab until disease progression, unacceptable toxicity, or completion of 1 year of maintenance.\n\nEfficacy and safety assessments will be performed per protocol. Tumor response will be assessed by site investigators according to the 2014 Lugano criteria, including determination of response status, date of response, and date of progression\u002Frelapse.",[188],"2026-05-20",{"date":439,"type":32},"2026-05-27",{"date":441,"type":21},"2026-06-01",{"date":361,"type":21},{"name":444,"class":39},"The First Affiliated Hospital with Nanjing Medical University",{"id":446,"slug":447,"hasResults":12,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":4,"eligibilityCriteria":451,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":452,"targetDuration":4,"studyType":22,"phases":454,"briefSummary":455,"conditions":456,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":461,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":40},"100639830","phase-1-a-phase--study-of-cs08399-in-participants-with-mtap-deleted-solid-tumors-and-lymphoma-100639830","NCT07583771","A Phase Ⅰ Study of CS08399 in Participants With MTAP-deleted Solid Tumors and Lymphoma","A Phase Ⅰ Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamic and Preliminary Efficacy of CS08399 in Participants With MTAP-deleted Solid Tumors and Lymphoma","Inclusion Criteria:\n\n1. Understand and sign the informed consent form voluntarily.\n2. ≥18 years old when signing the informed consent, regardless of sex.\n3. Histologically or cytologically confirmed locally advanced or metastatic solid tumors, or relapsed\u002Frefractory lymphoma, for which standard therapy has failed or is not tolerated, and no further standard therapy is available. Homozygous MTAP or CDKN2A deletion confirmed by tissue or peripheral blood testing.\n4. For glioblastoma: at least one measurable intracranial tumor lesion according to the RANO 2.0 criteria. For other solid tumors: at least one measurable lesion according to RECIST v1.1 criteria. For lymphoma: at least one measurable lesion according to Lugano 2014 criteria.\n5. For glioblastoma: KPS score ≥60. For other solid tumors and lymphoma: ECOG performance status of 0 or 1.\n6. Adequate organ function.\n7. Life expectancy ≥3 months.\n8. Able to swallow and retain oral study medication.\n\nExclusion Criteria:\n\n1. Received any anti-tumor therapy (including but not limited to chemotherapy, targeted therapy, anti angiogenic therapy, immunotherapy, cell therapy, radiotherapy, tumor embolization, etc.) or experimental drugs\u002Fdevices that have not been approved for marketing within 28 days prior to the first dose or are still within 5 half-lives of such drugs (whichever is shorter).\n2. Previously received MAT2A or PRMT5 inhibitors.\n3. Underwent major surgery (cranial, thoracic, or abdominal) within 28 days prior to the first dose or have unresolved wounds, ulcers, or fractures.\n4. Have unresolved toxicities from previous treatments that have not recovered to CTCAE v5.0 grade ≤1.\n5. History of other primary malignancies within 5 years prior to the first dose.\n6. For solid tumors : The presence of active, clinically symptomatic central nervous system metastases or leptomeningeal metastases or spinal cord compression at screening.\n7. Primary central nervous system lymphoma or systemic lymphoma with CNS involvement.\n8. Evidence of interstitial lung disease, pulmonary fibrosis, or non-infectious pneumonitis requiring treatment on chest imaging at screening.\n9. Active infection requiring systemic anti-infective treatment at screening.\n10. Received drainage of pleural effusion, ascites, or pericardial effusion within 1 month prior to the first dose or have significant clinical symptoms.\n11. Uncontrolled or significant cardiovascular disease.\n12. Poorly controlled diabetes.\n13. Significant gastrointestinal abnormalities at screening that may affect drug intake, transport, or absorption.\n14. History of gastrointestinal perforation, fistula, peptic ulcer, bowel obstruction, or biliary obstruction within 6 months prior to the first dose.\n15. Clinically significant hemoptysis or tumor bleeding within 14 days prior to the first dose; significant active bleeding within 2 months prior to the first dose; currently on anticoagulants; high-risk bleeding tendency at screening.\n16. Serious thromboembolic events within 6 months prior to the first dose.\n17. Active tuberculosis at screening.\n18. Active hepatitis B or hepatitis C at screening.HIV infection or syphilis infection at screening.\n19. Allergy or hypersensitivity to any component of the trial drug or known excipients, or history of severe allergic diseases.\n20. History of organ transplantation or allogeneic hematopoietic stem cell transplantation.\n21. History of alcohol abuse or drug abuse.\n22. Any psychiatric or cognitive disorder that may limit understanding of informed consent, compliance with the protocol, or participation in the trial.\n23. Pregnant or breastfeeding women.\n24. Other conditions deemed unsuitable for participation in this trial by the investigator.",{"count":453,"type":21},186,[82],"This is a phase I, open-label, first-in-human study of CS08399, comprising two phases: dose escalation (including single-dose and multiple-dose) and cohort expansion. The primary objectives of this study are to evaluate the safety, tolerability and pharmacokinetic (PK) characteristics of CS08399 in participants with MTAP-deleted solid tumors and Lymphoma, and to recommended Phase 2 dose(s) (RP2D) of CS08399 in appropriate tumor(s).",[457,458,459,93,188],"Pancreatic Adenocarcinoma","Non Small Cell Lung Cancer","Advanced Solid Tumors","2026-05-07",{"date":462,"type":32},"2026-05-13",{"date":464,"type":21},"2026-06",{"date":466,"type":21},"2030-01",{"name":468,"class":71},"Chipscreen Biosciences, Ltd.",{"id":470,"slug":471,"hasResults":12,"nctId":472,"briefTitle":473,"officialTitle":474,"acronym":4,"eligibilityCriteria":475,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":476,"targetDuration":4,"studyType":22,"phases":478,"briefSummary":479,"conditions":480,"keywords":483,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":460,"lastUpdatePostDateStruct":487,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":493,"locationsCount":175},"100641004","phase-2-epcoritamab-in-combination-with-r-chop-for-patients-with-aggressive-non-hodgkin-lymphoma-100641004","NCT07588698","Epcoritamab in Combination With R-CHOP for Patients With Aggressive Non-Hodgkin Lymphoma","Epcoritamab in Combination With R-CHOP Debulking in Newly Diagnosed Patients With Aggressive Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n1. Participants must have confirmed CD20-positive aggressive B-cell lymphoma, including de novo or transformed diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS); high-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangement; primary mediastinal large B-cell lymphoma (PMBCL); T-cell\u002Fhistiocyte-rich large B-cell lymphoma (THRLBCL); Epstein-Barr virus-positive DLBCL, NOS; or follicular lymphoma grade 3b.\n2. Measurable disease per Lugano 2014 criteria.\n3. No prior therapy for DLBCL or FL G3B other than corticosteroids or palliative radiotherapy. Of note, a cycle of anthracycline-containing regimen (given as standard of care prior to study enrollment) is allowed, provided that patients will receive a total of six cycles of chemotherapy as part of their treatment plan. Patients who received one cycle of an anthracycline-containing regimen prior to enrollment will proceed directly to Cycle 2 on study.\n4. Age ≥18 years\n5. Participants must have an International Prognostic Index (IPI) score of 2-5.\n6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)\n7. Demonstrates adequate organ function as defined below:\n\n   Adequate bone marrow function:\n\n   absolute neutrophil count platelets\n   * 1.0 × 10⁹\u002FLitre (L) (with growth factor use allowed)\n   * 75 × 10⁹\u002FL\n\n   Exceptions:\n\n   Patients may be enrolled despite not meeting the thresholds above if either of the following applies, provided the Absolute Neutrophil Count (ANC) is ≥0.75 × 10⁹\u002FL:\n   1. The patient has received one prior cycle of chemotherapy off study, and cytopenias at Cycle 2, Day 1 of protocol therapy are believed to be due to recent chemotherapy, provided there is evidence of marrow recovery and no other contraindications.\n   2. The patient has documented bone marrow involvement by lymphoma, and cytopenias are believed to be disease-related rather than indicative of poor marrow reserve or unrelated pathology. In such cases, enrollment is permitted at the discretion of the investigator if the patient is otherwise eligible and deemed safe to proceed.\n\n   Adequate hepatic function:\n\n   Total bilirubin\n\n   ≤2 × upper limit of normal (ULN) (unless due to Gilbert's)\n\n   Aspartate aminotransferase (AST) Serum glutamic-oxaloacetic transaminase (SGOT)\n\n   ≤3 × institutional upper limit of normal\n\n   Alanine aminotransferase (ALT) Serum glutamic-pyruvic transaminase (SGPT)\n\n   ≤3 × institutional upper limit of normal\n\n   Adequate renal function:\n\n   As assessed by estimated glomerular filtration rate (eGFR)\n\n   Coagulation:\n\n   Prothrombin time (PT) International Normalized Ratio (INR) and Activated partial thromboplastin time aPTT\n\n   ≤1.5 × ULN, unless receiving anticoagulation therapy\n8. Left ventricular ejection fraction (LVEF) ≥50% by multigated acquisition (MUGA) or echocardiography at screening.\n9. Ability to understand and the willingness to sign a written informed consent document.\n10. .Human immunodeficiency virus (HIV)-infected individuals are eligible if the following criteria are met:\n\n    1. Serum HIV viral load is \\\u003C lower limit of detection (LLD) and controlled with antiretroviral therapy for at least 1 year prior to enrollment, with confirmatory testing at screening;\n    2. CD4 count ≥ 200 cells\u002Fmicroliter (μL) at screening;\n    3. Subject is receiving antiretroviral regimens in accordance with current International Acquired Immunodeficiency Syndrome (AIDS) Society guidelines;\n    4. No evidence of AIDS-defining illnesses (other than lymphoma diagnosis) or active opportunistic infections;\n    5. Antiretroviral therapy does not interfere with study medications.\n11. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n12. Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n13. Individuals 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.\n14. The effects of epcoritamab on the developing human fetus are unknown. For this reason, and because bispecific antibodies may be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, or abstinence). Woman with reproductive potential must agree to use adequate contraception during the trial, and for 12 months after the last administration of epcoritamab or according to the local prescribing information of the standard of care (SOC) regimens, whichever is the longest. Adequate contraception is defined as highly effective methods of contraception. Also refer to the local prescribing information for information regarding contraceptive requirements for the SOC regimens.\n15. A woman of childbearing potential must have a negative serum (beta-hCG) pregnancy test at screening and a negative urine pregnancy test before treatment administration on Day 1 of every cycle.\n16. A woman 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 or according to the local prescribing information of the SOC regimens, whichever is the longest.\n17. A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control, eg, either condom with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository or partner with occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository, and all men must also not donate sperm during the trial and for 12 months after receiving the last dose of epcoritamab or according to the local prescribing information of the SoC regimens, whichever is the longest.\n18. Participants must agree not to donate blood for 60 days after receiving the last dose of trial treatment.\n19. Participants must have a treating physician at University of California, San Francisco (UCSF) or Zuckerberg San Francisco General Hospital (ZSFGH), receive study treatment under the supervision of the study Principal Investigator or qualified study sub-investigators at the enrolling site, and be willing to comply with study procedures.\n\nExclusion Criteria:\n\n1. History of severe allergic or anaphylactic reactions to anti-CD20 mAb therapy or known allergy or intolerance to any component or excipient of epcoritamab.\n2. Any prior treatment with a bispecific antibody targeting CD3 and CD20.\n3. Treatment with an investigational drug within 4 weeks or 5 half-lives, whichever is longer, prior to the first dose of epcoritamab.\n4. Requiring immunosuppressive therapy for an ongoing baseline medical condition. For corticosteroids, prednisolone \\>10 mg daily (or equivalent) qualifies as immunosuppressive and thus be excluded for this use. Note: corticosteroids at any dose are permitted for control of lymphoma related symptoms, including during screening, and for any adverse events (AE) management during study.\n5. Vaccination with live vaccines within 28 days prior to the first dose of epcoritamab.\n6. Clinically significant cardiovascular disease, including:\n\n   1. Myocardial infarction within 6 months prior to the first dose of epcoritamab, or unstable or uncontrolled disease\u002Fcondition related to or affecting cardiac function (eg, unstable angina, congestive heart failure New York Heart Association Class III-IV), cardiac arrhythmia (NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5 Grade 3 or higher), or clinically significant electrocardiogram (ECG) abnormalities\n   2. Screening 12-lead ECG showing a baseline QT Corrected for Heart Rate using Fridericia's Formula (QTcF) \\>470 msec\n   3. Stroke within 6 months prior to first epcoritamab dose\n7. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at trial enrolment or significant infections within 2 weeks prior to the first dose of epcoritamab.\n8. Active hepatitis B Virus (HBV) (Deoxyribonucleic Acid Polymerase Chain Reaction (DNA PCR) -positive) or hepatitis C (Ribonucleic Acid Polymerase Chain Reaction (RNA PCR) -positive infection). Subjects with evidence of prior HBV but who are PCR-negative are permitted in the trial but should receive prophylactic antiviral therapy. Subjects who received treatment for Hepatitis C Virus (HCV) that was intended to eradicate the virus may participate if hepatitis C Ribonucleic acid (RNA) levels are undetectable.\n9. 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 Antigen (PSA) level \\\u003C 0.1 ng\u002Fmilliliter (mL)\n   5. Any curable cancer with a complete response (CR) of \\> 2 years duration.\n10. Neuropathy \\> grade 1 with the exception of neuropathy directly related to lymphoma (e.g., direct nerve compression from tumor).\n11. . Female who is pregnant, breast-feeding, or planning to become pregnant while enrolled in this trial or within 12 months after the last dose of epcoritamab; female subjects must also agree not to breastfeed during the entire trial and until 12 months after the last administration of study drug.\n12. Male who plans to father a child while enrolled in this trial or within 12 months after the last dose of epcoritamab.\n13. Contraindication to any of the individual drugs of the R-CHOP regimen.",{"count":477,"type":21},20,[24],"A Phase II, open-label, two-arm, multicenter study evaluating the combination of epcoritamab with R-CHOP chemotherapy in patients with newly diagnosed, aggressive B-cell non-Hodgkin lymphoma.",[481,482,188],"Non-Hodgkin's B-cell Lymphoma","Lymphoma Non-Hodgkin",[484,485,486],"Newly diagnosed B-cell lymphoma patients","Combination immunotherapy chemotherapy","epcoritamab R-CHOP lymphoma trial",{"date":488,"type":32},"2026-05-15",{"date":490,"type":21},"2026-07-15",{"date":492,"type":21},"2029-07-31",{"name":494,"class":39},"Mwanasha Merrill, MD",{"id":496,"slug":497,"hasResults":12,"nctId":498,"briefTitle":499,"officialTitle":499,"acronym":500,"eligibilityCriteria":501,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":502,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":504,"conditions":505,"keywords":508,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":512,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":40},"100579325","multicenter-retrospective-observational-study-of-relapsed-diffuse-large-b-cell-lymphoma-presenting-as-indolent-lymphoma-100579325","NCT06822829","Multicenter Retrospective Observational Study of Relapsed Diffuse Large B-Cell Lymphoma Presenting as Indolent Lymphoma","REVERSE_2021","Inclusion Criteria:\n\n* Age 18 years or older at the time of diagnosis.\n* Previous diagnosis of diffuse large B-cell lymphoma with\u002Fwithout a discordant component of indolent B-cell lymphoma, or previous diagnosis of diffuse large B-cell lymphoma transformed from indolent B-cell lymphoma.\n* First-line treatment for diffuse large B-cell lymphoma.\n* Histologically documented relapse of indolent B-cell lymphoma, diagnosed between 2010 and 2020.\n* Availability of the histological report of the relapse.\n* Availability of clinical and laboratory data related to both the initial diagnosis and relapse.\n* Availability of follow-up data.\n* Consent to participate in the study and signing of the specific informed consent form (for living and\u002For contactable patients).\n\nExclusion Criteria:\n\n\\- None",{"count":503,"type":21},50,"Most relapses of diffuse large B-cell lymphoma (DLBCL) occur as high-grade lymphoma within the first two years after diagnosis. Relapses as indolent lymphoma are rare events, and the true incidence of this phenomenon is unknown, since literature data are scarce\u002F and usually restricted to case reports. Analogously, reported treatment strategies are rather heterogeneous, since no standard of care is established and advanced age together with previous anthracycline exposure may narrow the therapeutic choice.\n\nThe goal of this observational study is to assess epidemiological, clinical characteristics and survival of diffuse large b-cell lymphoma (DLBCL) relapsing as indolent lymphoma.\n\nMore precisely, the study aims at identifying diagnostic and imaging features associated with relapse as indolent lymphoma and at evaluating disease response to selected therapies.",[27,506,507],"Indolent B-Cell Lymphomas","Indolent B Cell Lymphoma",[509,510],"indolent relapse","diffuse large b cell lymphoma","2026-05-04",{"date":513,"type":32},"2026-05-05",{"date":515,"type":32},"2024-08-19",{"date":517,"type":21},"2026-08",{"name":519,"class":520},"Azienda USL Reggio Emilia - IRCCS","OTHER_GOV",{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":4,"eligibilityCriteria":527,"healthyVolunteers":12,"sex":17,"minAge":528,"maxAge":4,"enrollmentInfo":529,"targetDuration":4,"studyType":22,"phases":531,"briefSummary":532,"conditions":533,"keywords":534,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":537,"lastUpdatePostDateStruct":538,"startDateStruct":540,"completionDateStruct":541,"leadSponsor":543,"locationsCount":40},"100561805","phase-2-mosunetuzumab-and-polatuzumab-vedotin-with-split-dose-chp-chemotherapy-for-elderly-patients-with-diffuse-large-b-cell-lymphoma-100561805","NCT06594939","Mosunetuzumab and Polatuzumab Vedotin With Split-Dose CHP Chemotherapy for Elderly Patients With Diffuse Large B-Cell Lymphoma","Multicenter Phase II Study of Mosunetuzumab and Polatuzumab Vedotin With Split-Dose CHP Chemotherapy for Elderly Patients With Diffuse Large B-Cell Lymphoma","Inclusion Criteria:\n\n1. Patients aged 70-74 who are determined to be unfit or frail by the Cumulative Illness Rating Scale-Geriatric (CIRS-G) score with 5-8 comorbid conditions scored 2 or more than 1 comorbidity scored 3-4 are allowed.\n2. Newly diagnosed, untreated, biopsy-proven CD20 positive diffuse large B-cell lymphoma (DLBCL) (including high-grade B-cell lymphoma and T-cell\u002Fhistiocyte-rich large B-cell lymphoma). Patients with discordant bone marrow (i.e., involved by low-grade\u002Findolent non-Hodgkin lymphoma) are eligible. Patients with transformed DLBCL from underlying low-grade disease are eligible. Patients with composite DLBCL and concurrent low-grade lymphoma are eligible. Patients with prior treatment for low-grade NHL with non-anthracycline based regimens are eligible.\n\n   a. Short-course prednisone or equivalent steroid for symptom management is allowable for up to seven days.\n3. Measurable disease by positron emission tomography (PET) \u002F computed tomography (CT) using the Lugano criteria (lymph node \\>1.5 cm or extranodal site \\>1.0 cm).\n4. Adequate biospecimen sample that meets current Adaptive Clonality ID Test specimen requirements for DLBCL.\n\n   a. Note: the preferred ID specimen type is a formalin-fixed paraffin-embedded (FFPE) lymph node biopsy, either FFPE slides or scrolls, targeting 40 microns of material.\n5. Left ventricular ejection fraction ≥50% by echocardiography or multigated acquisition (MUGA) scan.\n6. Karnofsky Performance Score ≥50 or Eastern Cooperative Oncology Group (ECOG) scan 0-2.\n7. Ann Arbor Stage II bulky, III, or IV disease.\n8. Minimum life expectancy greater than 3 months (should be explicitly documented by the enrolling investigator).\n9. Negative HIV test. Individuals with a positive HIV test at screening are eligible provided that, prior to enrollment, they are stable on antiretroviral therapy for at least 4 weeks, have a CD4 count ≥200\u002FµL, and have an undetectable viral load, and have not had a history of opportunistic infection attributable to acquired immunodeficiency syndrome (AIDS) within the last 12 months.\n10. For patients with hepatitis B virus antigen (HBsAg) or core antibody (HBcAb) seropositivity, patients must have a negative hepatitis B viral load and an appropriate prophylaxis plan must be in place during chemotherapy therapy treatment. For all patients that are hepatitis B core antibody positive, they should take entecavir prophylaxis (0.5 mg by mouth daily) until 1 year from completion of chemotherapy. Hepatitis B viral load should be checked on these patients prior to starting chemotherapy and every 3 months thereafter if initial hepatitis B viral load is negative (±1 week if chemotherapy cycle is delayed). If hepatitis B viral load is positive, hepatology or ID referral is recommended, and hepatitis B viral load should be checked monthly and every 3 months for 12 months after end of treatment.\n11. For patients with hepatitis C Ab positivity, a viral load must be checked and negative for enrollment.\n12. Negative SARS-CoV-2 antigen or polymerase chain reaction (PCR) test within 7 days prior to enrollment.\n13. Had at least one dose of a COVID-19 vaccine approved or authorized for emergency use by the FDA.\n14. Intrathecal chemotherapy for central nervous system prophylaxis can only be given at the discretion of the primary oncologist.\n\n    a. Note: patients who received high-dose methotrexate are not eligible for the study.\n15. 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:\n\n    1. 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 \\\u003C1% per year during the treatment period and for 6 months after the final dose of Mosun-Pola-SD-CHP. Male participants must refrain from donating sperm during this same period.\n    2. 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 Informed Consent Form.\n16. Ability to understand a written informed consent document, and the willingness to sign it.\n17. In the opinion of the enrolling investigator, subject must be deemed able to comply with the study intervention.\n\nExclusion Criteria:\n\n1. Prior treatment for DLBCL with chemotherapy, immunotherapy, and biologic therapy.\n2. Current Grade \\>1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease.\n3. Prior allogeneic or autologous stem cell transplant.\n4. Prior solid organ transplant.\n5. Known or suspected history of hemophagocytic lymphohistiocytosis (HLH).\n6. Known or suspected chronic active Epstein-Barr Virus (EBV) infection.\n7. History of progressive multifocal leukoencephalopathy (PML).\n8. Current or within 6 months of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease.\n9. Patients with SARS-CoV-2 antigen or PCR testing positivity within 30 days prior to Cycle 1 Day 1.\n\n   a. Any patient with documented SARS-CoV-2 infection within 6 months prior to planned Cycle 1 Day 1 must have no persistent respiratory symptoms, no evidence of residual sequelae, and have a negative PCR test for SARS-CoV-2.\n10. Administration of a live, attenuated vaccine within 4 weeks before start of study therapy or anticipation that such a live, attenuated vaccine will be required during the study.\n11. On immunosuppressant therapy for an active autoimmune disease, including, but not limited to myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with anti-phospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.\n\n    a. Exceptions may be made for patients with a remote history of or well-controlled autoimmune disease, excluding patients on systemic immunosuppression for autoimmune disease, or patients who received such immunosuppression within 1 year prior.\n12. Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis.\n13. Recent major surgery within 4 weeks before the start of C1D1 with the exception of lymph node biopsies for diagnosis.\n14. Prior treatment with radiotherapy within 2 weeks prior to Cycle 1 Day 1.\n\n    1. If patients have received radiotherapy within 4 weeks prior to the initiation of study treatment, patients must have at least one measurable lesion outside of the radiation field to be eligible.\n    2. Patients who have only one measurable lesion that was previously irradiated but subsequently progressed are eligible.\n15. History of previous anthracycline exposure.\n16. CNS or meningeal involvement at diagnosis.\n17. Richter's Transformation (e.g., DLBCL transformed from an underlying chronic lymphocytic leukemia (CLL) ).\n18. Patients with primary mediastinal large B cell lymphoma (PMBCL).\n19. Creatinine clearance \\\u003C40 mL\u002Fmin by Cockcroft-Gault.\n20. Poor hepatic function, defined as total bilirubin concentration greater than 3.0 mg\u002FdL or transaminases over 4 times the maximum normal concentration, unless these abnormalities are felt to be related to the lymphoma (which should be explicitly documented by the enrolling physician).\n21. Pulmonary dysfunction, defined as receiving supplemental O2 or significant pulmonary comorbidities (e.g., history of pneumonitis, severe chronic obstructive pulmonary disease (COPD) ).\n22. Significant cardiovascular disease (e.g., New York Heart Association Class III or IV cardiac disease, congestive heart failure, myocardial infarction within the previous 6 months, unstable arrhythmias, or unstable angina) or significant pulmonary disease.\n23. Active infectious disease (if patient is on medications for such situations, enrolling physician should explicitly document justification of meeting this criteria).\n24. Known concurrent bone marrow malignancies (e.g., myelodysplastic syndrome) or poor bone-marrow reserve, defined as neutrophil count less than 1.5 × 10\\^9\u002FL or platelet count less than 100 × 10\\^9\u002FL, unless caused by bone-marrow infiltration with lymphoma.\n25. History of a second concurrent active malignancy or prior malignancy which required chemotherapy treatment within the preceding 2 years (other than cured basal or squamous cell carcinoma, low-risk prostate cancer on observation, and other in situ carcinomas that were completely treated).\n26. Treatment with any investigational drug within 30 days before enrollment.\n27. Unable or unwilling to sign consent.","70 Years",{"count":530,"type":21},31,[24],"This single-arm, interventional phase 2 study is designed to evaluate whether the inclusion of mosunetuzumab subcutaneous and polatuzumab vedotin (Mosun-Pola) to a split-dose CHP chemotherapy backbone will improve outcomes for elderly patients with a new diagnosis of diffuse large B-cell lymphoma.",[27],[535,536],"Mosunetuzumab","Polatuzumab vedotin","2026-04-27",{"date":539,"type":32},"2026-05-01",{"date":464,"type":21},{"date":542,"type":21},"2029-12",{"name":544,"class":39},"Medical College of Wisconsin",{"id":546,"slug":547,"hasResults":12,"nctId":548,"briefTitle":549,"officialTitle":550,"acronym":4,"eligibilityCriteria":551,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":528,"enrollmentInfo":552,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":554,"conditions":555,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":537,"lastUpdatePostDateStruct":558,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":564,"locationsCount":40},"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.",{"count":553,"type":21},45,"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.",[27,556,557],"Primary Mediastinal Large B-cell Lymphoma (PMBCL)","Acute Lymphoblastic Leukemia (ALL)",{"date":559,"type":32},"2026-04-30",{"date":561,"type":32},"2022-04-26",{"date":563,"type":21},"2026-12-31",{"name":565,"class":39},"Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia",{"id":567,"slug":568,"hasResults":12,"nctId":569,"briefTitle":570,"officialTitle":571,"acronym":572,"eligibilityCriteria":573,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":574,"targetDuration":4,"studyType":22,"phases":576,"briefSummary":577,"conditions":578,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":579,"lastUpdatePostDateStruct":580,"startDateStruct":582,"completionDateStruct":584,"leadSponsor":586,"locationsCount":588},"100519987","phase-2-feasibility-trial-of-glofitamab-in-a-response-adapted-approach-incorporating-interim-fdg-pet-and-ctdna-to-optimize-primary-therapy-of-dlbcl-grail-100519987","NCT06050694","Feasibility Trial of Glofitamab in a Response Adapted Approach Incorporating Interim FDG PET and ctDNA to Optimize Primary Therapy of DLBCL (GRAIL)","Feasibility Trial of Glofitamab in a Response Adapted Approach Incorporating Interim FDG PET and ctDNA to Optimize Primary Therapy of DLBCL","GRAIL","Inclusion Criteria:\n\n1. Men and women ≥ 18 years of age deemed eligible for treatment with full-dose Pola- R-CHP and possible treatment with glofitamab by the qualified investigator.\n2. Histologic diagnosis of DLBCL and variants according to the WHO 201613 or WHO 202254 classification including DLBCL non-organ-specific (NOS), Germinal centre B-cell type, activated B-cell type, T-cell\u002Fhistiocyte-rich large B-cell lymphoma, Epstein-Barr Virus (EBV) + DLBCL, Primary mediastinal\u002Fthymic large B-cell lymphoma, High grade B-cell lymphoma with myelocytomatosis oncogene (MYC) and B-cell lymphoma 2 (BCL2) and\u002For B-cell lymphoma 6 (BCL6) rearrangements, High grade B cell lymphoma NOS including lymphomas transformed from previously untreated indolent lymphomas.\n3. Previously untreated DLBCL with the following exceptions: (a) prior radiotherapy for palliation (not localized), (b) up to 7 days of corticosteroids (prednisone 100mg\u002Fday equivalent).\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.\n5. Presence of at least one radiologically measurable nodal or extranodal mass. A measurable nodal mass must have a longest diameter ≥1.5 cm. A measurable extranodal mass should have a longest diameter ≥1.0 cm.16\n6. Left ventricular ejection fraction (LVEF) ≥ 50%, as determined on cardiac multiple- gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)\n7. Women of childbearing potential (WOCBP) who are sexually active must use highly effective methods of contraception during treatment and up to 18 months after the last dose of or protocol therapy. Men who are sexually active must use highly effective methods of contraception during treatment and up to 6 months after the last dose of protocol therapy. Men require an agreement to remain abstinent (ie, refrain from heterosexual intercourse) or use a condom, and an agreement to refrain from donating sperm. Periodic abstinence and withdrawal are not acceptable methods of contraception. Fertility preservation options should be discussed. Examples of highly effective contraceptive methods include an agreement to remain abstinent (ie, refrain from heterosexual intercourse), bilateral tubal ligation, male sterilization, established proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n8. Willing and able to participate in all required evaluations and procedures in this study.\n9. Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained by the patient or legally acceptable representative before any study-specific procedures are performed.\n\nExclusion Criteria:\n\n1. Current\u002Fpast history of central nervous system (CNS) lymphoma.\n2. Prior exposure to any anthracycline, rituximab or cluster of differentiation 3 (CD3) targeted bispecific antibody.\n3. Prior malignancy (or any other malignancy requiring active treatment), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for ≥ 2 years or which will not limit survival to \\\u003C 5 years. Subjects receiving adjuvant hormonal therapy for early breast or prostate cancer are eligible.\n4. Significant or extensive 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 6 months, unstable arrhythmias, or unstable angina. Subjects with controlled, asymptomatic atrial fibrillation during screening can enroll on study.\n5. Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including diabetes mellitus, history of relevant pulmonary disorders (bronchospasm, obstructive pulmonary disease), and known autoimmune diseases.\n6. Patients with a known or suspected history of hemophagocytic lymphohistiocytosis (HLH)\n7. History of illicit drug or alcohol abuse within 12 months prior to screening, in the Investigator's judgment.\n8. Known active infection, or reactivation of a latent infection, whether bacterial, viral (including, but not limited to, EBV, cytomegalovirus (CMV), hepatitis B, hepatitis C, and human immunodeficiency virus (HIV), fungal, mycobacterial, or other pathogens (excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics (for IV antibiotics this pertains to completion of last course of antibiotic treatment) within 4 weeks of dosing. Individuals with a positive HIV test at screening are eligible provided they are stable on antiretroviral therapy, have a cluster of differentiation 4 (CD4) count ≥ 200\u002FμL, and have an undetectable viral load. HIV positive patients should be monitored per local\u002Finstitutional standards while receiving study treatment.\n9. Known history of drug-specific hypersensitivity or anaphylaxis to study drugs (glofitamab and individual components of Pola-R-CHP), including grade III or greater allergic reactions to any monoclonal antibody.\n10. Known Type I hypersensitivity or anaphylactic reactions to murine proteins, Chinese Hamster Ovary (CHO) cell proteins, or to any component of Rituximab\n11. Current history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease. Patients with a history of stroke who have not experienced a stroke or transient ischemic attack within the past 2 years and have no residual neurological deficient, as judged by the investigator, are allowed.\n12. Active autoimmune disease which is not well controlled by therapy:\n\n    * Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid-replacement hormone may be eligible. Participants with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n    * Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.\n    * Participants with active autoimmune disease with dermatologic manifestations are eligible for the study.\n    * Participants with a history of autoimmune hepatitis, systemic lupus erythematosus, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, multiple sclerosis, or glomerulonephritis will be excluded.\n    * Participants with a history of immune thrombocytopenic purpura, autoimmune hemolytic anemia, Guillain-Barré syndrome, myasthenia gravis, myositis, rheumatoid arthritis, vasculitis, or other autoimmune disease will be excluded unless they have not required systemic therapy in the last 12 months\n13. Major surgical procedure within 4 weeks of 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.\n14. Administration of a live, attenuated vaccine within 4 weeks before study treatment infusion on Cycle 1\u002FDay 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. Note: Influenza vaccination should be given during influenza season only. Participants must not receive live, attenuated influenza vaccine (e.g., FluMist) at any time during the study treatment period).\n15. Use of any of the prohibited therapies including: investigational or unlicensed\u002Funapproved agents; biologic agents (e.g., bevacizumab, erlotinib); immunotherapy\u002Fradio-immunotherapy; radiotherapy (with the exception of limited field palliative radiotherapy for bone pain or for soft tissue lesions after consultation with the Sponsor); chemotherapy (apart from Pola-R-CHP per protocol); hormone therapy (other than contraceptives, hormone-replacement therapy, or megestrol acetate); chronic use of steroids (inhaled, topical or systemic)\n16. Positive test results for hepatitis B virus (HBV) infection (defined as positive B surface antigen \\[HBsAg\\] serology). Patients with occult or prior HBV infection (defined as negative HBsAg and positive hepatitis B core antibody \\[HBcAb\\]) may be included if HBV DNA is undetectable, provided that they are willing to undergo DNA testing on Day 1 of every cycle and every three months for at least 12 months after the last cycle of study treatment and appropriate antiviral therapy.\n17. Positive test results for hepatitis C virus (HCV) antibody. Patients who are positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.\n18. Absolute Neutrophil Count (ANC) \\\u003C1.0 x109\u002FL (subjects with bone marrow involvement by lymphoma are eligible regardless of ANC).\n19. Hemoglobin (Hgb) ≤ 9 g\u002FdL\n20. Platelets \\\u003C50 x109\u002FL (subjects with bone marrow involvement by lymphoma are eligible regardless of platelet count)\n21. Total serum bilirubin \\>2 times the upper limit of normal (or \\\u003C3 times for Gilbert's disease or documented hepatic involvement by lymphoma), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\>3 times the upper limit of normal (or \\>5 times for documented hepatic involvement by lymphoma)\n22. Creatinine clearance \\\u003C30 mL\u002Fmin.\n23. Prothrombin time (PT)\u002F international normalized ratio (INR) \\>2 times the upper limit of normal in the absence of anticoagulants or partial thromboplastin time (PTT) \\>2 times the upper limit of normal in the absence of anticoagulants.\n24. Breastfeeding or pregnant, or intending to become pregnant during the study or within 12 months after the final dose of Pola-R-CHP, 3 months after the final dose of tocilizumab (if applicable), or 2 months after the final dose of glofitamab. WOCBP must have a serum pregnancy test done a maximum of 7 days prior to treatment initiation and a negative result must be documented prior to recruitment.\n25. Concurrent participation in another therapeutic clinical trial.\n26. Any other diseases, metabolic dysfunction, physical examination finding, or clinical\n27. Laboratory finding giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug.\n28. Current Grade \\> 1 peripheral neuropathy by clinical examination or demyelinating form of Charcot Marie Tooth disease.\n29. Known history of progressive multifocal leukoencephalopathy.\n30. Positive severe acute respiratory syndrome (SARS-CoV-2) test within 7 days prior to enrollment. Rapid antigen test result is also acceptable.\n31. Known or suspected chronic active Epstein-Barr viral infection.",{"count":575,"type":21},40,[24],"This is a phase ll study of participants with untreated diffuse large B Cell lymphoma (DLBCL).",[27],"2026-04-21",{"date":581,"type":32},"2026-04-24",{"date":583,"type":32},"2025-01-24",{"date":585,"type":21},"2027-11",{"name":587,"class":39},"University Health Network, Toronto",3,{"id":590,"slug":591,"hasResults":12,"nctId":592,"briefTitle":593,"officialTitle":594,"acronym":4,"eligibilityCriteria":595,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":596,"enrollmentInfo":597,"targetDuration":4,"studyType":22,"phases":599,"briefSummary":600,"conditions":601,"keywords":602,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":608,"lastUpdatePostDateStruct":609,"startDateStruct":611,"completionDateStruct":613,"leadSponsor":615,"locationsCount":40},"100633211","phase-2-pomalidomide-anti-pd-1-antibody-combined-with-selinexor-pps-in-relapsedrefractory-primary-central-nervous-system-diffuse-large-b-cell-lymphoma-100633211","NCT07523737","Pomalidomide, Anti-PD-1 Antibody Combined With Selinexor (PPS) in Relapsed\u002FRefractory Primary Central Nervous System Diffuse Large B-Cell Lymphoma","Pomalidomide, Anti-PD-1 Antibody Combined With Selinexor (PPS) in Relapsed\u002FRefractory Primary Central Nervous System Diffuse Large B-Cell Lymphoma: A Prospective, Multicenter, Single-Arm, Phase II Clinical Study","Inclusion Criteria:\n\n* Histologically confirmed primary central nervous system diffuse large B-cell lymphoma (PCNSL-DLBCL).\n* Disease progression or relapse after prior treatment with high-dose methotrexate and\u002For BTK inhibitors.\n* Age between 18 and 75 years.\n* ECOG performance status score 0-4.\n* Expected overall survival \\> 3 months.\n* No known hypersensitivity to any study drug.\n* White blood cell count ≥ 3×10⁹\u002FL; absolute neutrophil count ≥ 1.0×10⁹\u002FL; platelet count ≥ 50×10⁹\u002FL.\n* Serum creatinine ≤ 1.5 mg\u002FdL; creatinine clearance ≥ 50 mL\u002Fmin.\n* ALT and AST ≤ 3× upper limit of normal (ULN); total bilirubin ≤ 2× ULN.\n* Signed written informed consent.\n\nExclusion Criteria:\n\n* Presence of another malignant tumor requiring active pharmacological or surgical intervention at present;\n* Female patients who are pregnant or breastfeeding;\n* Patients (male or female) of reproductive potential who are unwilling to use or fail to use effective contraceptive measures;\n* Known hypersensitivity to any study drug or any excipient ingredients of these products;\n* Active infection (determined by the investigator);\n* History of immunodeficiency, including positive HIV status, other acquired or congenital immunodeficiency disorders, or history of organ transplantation;\n* Documented history of neurological or psychiatric disorders, including epilepsy or dementia;\n* Documented history of autoimmune diseases (except Hashimoto's thyroiditis or thyroid dysfunction);\n* Any severe comorbidity that, in the investigator's judgment, would compromise patient safety or interfere with the completion of the study.","75 Years",{"count":598,"type":21},43,[24],"Primary central nervous system diffuse large B-cell lymphoma (PCNSL-DLBCL) is a highly aggressive malignancy accounting for over 80% of primary CNS lymphomas, with an annual incidence of 0.4-0.6 per 100,000 people globally and a rising trend in immunocompetent patients. First-line high-dose methotrexate-based chemotherapy causes severe toxicities and nearly 50% of patients relapse within 1-2 years, developing relapsed\u002Frefractory (R\u002FR) disease.\n\nTreatment options for R\u002FR PCNSL are scarce, with low response rates, median survival of only 3-6 months, and 5-year survival below 5%. The blood-brain barrier and tumor heterogeneity further worsen outcomes. This prospective, multicenter, single-arm phase II study evaluates the efficacy and safety of pomalidomide, PD-1 inhibitor, and selinexor (PPS) in R\u002FR PCNSL, aiming to provide a new effective treatment.",[87,27],[510,603,604,605,606,607],"primary central nervous system lymphoma","pomalidomide","PD-1 inhibitor","XPO1 inhibitor","selinexor","2026-04-10",{"date":610,"type":32},"2026-04-15",{"date":612,"type":32},"2026-04-01",{"date":614,"type":21},"2028-08-31",{"name":616,"class":39},"Beijing Tongren Hospital",{"id":618,"slug":619,"hasResults":12,"nctId":620,"briefTitle":621,"officialTitle":622,"acronym":4,"eligibilityCriteria":623,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":404,"enrollmentInfo":624,"targetDuration":4,"studyType":22,"phases":626,"briefSummary":627,"conditions":628,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":629,"lastUpdatePostDateStruct":630,"startDateStruct":632,"completionDateStruct":634,"leadSponsor":636,"locationsCount":40},"100612994","phase-1-ksv01-injection-for-the-treatment-of-relapsedrefractory-diffuse-large-b-cell-lymphoma-100612994","NCT07260812","KSV01 Injection for the Treatment of Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma","A Phase I Clinical Study on the Safety, Tolerability, and Efficacy of KSV01 Injection in Patients With Relapsed\u002FRefractory Diffuse Large B-cell Lymphoma","Inclusion Criteria:\n\n1. Patients or their legal guardians voluntarily participate in the study and provide written informed consent.\n2. Aged 18 to 80 years (inclusive), male or female.\n3. ECOG performance status score of ≤ 1.\n4. Life expectancy \\> 3 months.\n5. KPS score ≥ 70.\n6. Patients with diffuse large B-cell lymphoma (DLBCL) diagnosed according to the 2016 WHO classification. Patients with DLBCL should have been diagnosed as relapsed or refractory after at least one prior line of systemic therapy.\n7. CD19 positivity confirmed by flow cytometry and\u002For histopathology.\n8. According to the Lugano 2014 criteria, the presence of PET-positive target lesions for tumor assessment is required (Deauville 5-Point Scale \\[5-PS\\] ≥ 4).\n9. Adequate organ function.\n10. Female patients of childbearing potential must have a negative urine\u002Fblood pregnancy test during the screening period and agree to use effective contraception for at least 1 year after infusion; male subjects with partners of childbearing potential must agree to use effective barrier contraception for at least 1 year after infusion.\n\nExclusion Criteria:\n\n1. History of another primary malignancy that has not been in continuous remission for at least 2 years, except for the following conditions which are exempt from the 2-year limit: non-melanoma skin cancer, Stage I solid tumors treated with curative intent and low risk of recurrence, cured localized prostate cancer, biopsy-confirmed carcinoma in situ of the cervix, or squamous intraepithelial lesion identified on Pap smear.\n2. Uncontrolled infectious disease within 4 weeks prior to enrollment.\n3. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n4. HIV infection.\n5. Positive for Treponema pallidum(syphilis).\n6. Severe autoimmune disease or immunodeficiency, with the exception of well-controlled Type I diabetes and thyroid disorders.\n7. History of severe allergy or hypersensitivity to macromolecular biologic agents (e.g., antibodies, cytokines).\n8. Participation in any other clinical trial within 4 weeks prior to enrollment.\n9. History of clinically significant central nervous system (CNS) diseases, including but not limited to epilepsy, paresis, aphasia, stroke, severe head injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome.\n10. Presence of isolated CNS involvement by lymphoma, or any ongoing CNS condition that precludes accurate neurological evaluation.\n11. History of severe cardiovascular conditions within the past 6 months.\n12. Presence of psychiatric illness.\n13. History of drug abuse or addiction.\n14. Use of the following medications or therapies:\n\n    1. Corticosteroids (physiologic replacement doses, and topical or inhaled steroids are permitted).\n    2. Chemotherapy.\n    3. GvHD Therapy.\n    4. Allogeneic hematopoietic stem cell transplantation.\n    5. Gene therapy.\n15. Women who are breastfeeding.\n16. In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures (including follow-up visits) or unlikely to comply with the requirements for participation in this study.",{"count":625,"type":21},18,[82],"This is a single center, single arm, open-label, dose escalation, phase 1 study to evaluate the safety, tolerability and preliminary efficacy of KSV01 Injection for patients with diffuse large B-cell lymphoma.",[381,27],"2026-04-07",{"date":631,"type":32},"2026-04-13",{"date":633,"type":32},"2025-09-01",{"date":635,"type":21},"2028-12-31",{"name":637,"class":71},"TCRx Therapeutics Co.Ltd",{"id":639,"slug":640,"hasResults":12,"nctId":641,"briefTitle":642,"officialTitle":643,"acronym":4,"eligibilityCriteria":644,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":528,"enrollmentInfo":645,"targetDuration":4,"studyType":22,"phases":646,"briefSummary":647,"conditions":648,"keywords":649,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":653,"lastUpdatePostDateStruct":654,"startDateStruct":656,"completionDateStruct":658,"leadSponsor":660,"locationsCount":40},"100631330","phase-2-genetic-subtype-matched-targeted-therapy-for-the-treatment-of-newly-diagnosed-dlbcl-with-tp53-mutation-100631330","NCT07499271","Genetic Subtype-matched Targeted Therapy for the Treatment of Newly Diagnosed DLBCL With TP53 Mutation","A Prospective, Exploratory Clinical Study of Genetic Subtype-matched Precision Targeted Therapy in Newly Diagnosed DLBCL With TP53 Mutation","Inclusion Criteria:\n\n1. Patients aged 18 years and older, up to 70 years.\n2. Participants must be able to understand and willing to sign the written informed consent form.\n3. Eastern Cooperative Oncology Group performance status 0 to 3.\n4. Life expectancy ≥3 months (as determined by the investigator).\n5. Pathologically (histologically or cytologically) confirmed treatment-naive CD20-positive diffuse large B-cell lymphoma.\n6. Measurable disease defined by PET-CT as a short-axis diameter of at least ≥1.5 cm.\n7. Bone marrow and organ function meeting the following criteria (without blood transfusion, G-CSF, or medication correction within 14 days prior to screening):\n\n   Bone marrow function: Absolute neutrophil count ≥1.5×10⁹\u002FL, platelet count ≥80×10⁹\u002FL, hemoglobin ≥80 g\u002FL.\n\n   Liver function: Total serum bilirubin ≤1.5×ULN (≤3.0×ULN if liver metastases present); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN (≤5.0×ULN if liver metastases present).\n\n   Coagulation function: International normalized ratio (INR) and activated partial thromboplastin time ≤1.5×ULN.\n\n   Renal function: Serum creatinine ≤1.5×ULN or estimated creatinine clearance ≥60 mL\u002Fmin (for males: Cr (mL\u002Fmin) = (140 - age) × body weight (kg) \u002F \\[72 × serum creatinine concentration (mg\u002FdL)\\]; for females: Cr (mL\u002Fmin) = (140 - age) × body weight (kg) \u002F \\[85 × serum creatinine concentration (mg\u002FdL)\\]).\n8. Females of childbearing potential must agree to use highly effective contraceptive methods during the treatment period and for 5 weeks after the last dose of study drug. Sexually active males must agree to use highly effective contraception during the treatment period and for 3 months after the last dose.\n9. No difficulty swallowing oral tablets\u002Fcapsules.\n10. Good compliance and willingness to adhere to visit schedules, dosing schedules, laboratory tests, and other examination procedures.\n\nExclusion Criteria:\n\n1. Patients who have previously received systemic anti-tumor therapy.\n2. Patients with central nervous system involvement.\n3. Patients who received systemic adrenal corticosteroids for more than 5 days within 14 days prior to study drug administration, or who require daily doses of \\>10 mg of dexamethasone or equivalent drugs to control central nervous system disease.\n4. Active concurrent malignancy requiring active treatment.\n5. Uncontrolled or severe cardiovascular disease, including (but not limited to) any of the following: congestive heart failure (NYHA class III or IV); myocardial infarction; unstable angina; or presence of arrhythmia requiring treatment at screening, with left ventricular ejection fraction (LVEF) \\\u003C 50% within 6 months prior to the first dose; primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, undefined cardiomyopathy); clinically significant history of QTc prolongation, second-degree type II atrioventricular block or third-degree atrioventricular block, or QTc interval (Fridericia's method) \\> 470 ms (female) or \\> 480 ms (male); atrial fibrillation; patients with uncontrolled hypertension considered unsuitable for participation in the study.\n6. Uncontrolled infection or infection requiring intravenous antibiotic therapy.\n7. Chronic hepatitis B carriers with active hepatitis B or hepatitis C infection (hepatitis B: acute hepatitis B, untreated chronic hepatitis B virus infection, HBV-DNA ≥ the detection limit of the respective center; hepatitis C: HCV RNA positive) or syphilis. Note: Inactive hepatitis B surface antigen (HBsAg) carriers, subjects with active HBV infection and sustained HBV suppression (HBV DNA \\\u003C detection limit of the respective center), and subjects cured of HCV may be enrolled.\n\n   Human immunodeficiency virus (HIV) infection.\n8. Clinically significant gastrointestinal abnormalities that may affect drug intake, transport, or absorption (such as active gastrointestinal inflammation, chronic diarrhea, intestinal obstruction, etc.), or patients with total gastrectomy, gastric banding surgery, or tumor involvement of the gastrointestinal tract.\n9. Patients with a history of bleeding disorders, or patients requiring long-term oral anticoagulation due to comorbidities.\n10. Female subjects who are currently pregnant or breastfeeding.\n11. Allergy to the study drug or excipients.\n12. Patients with active psychiatric disorders, alcohol dependence, drug dependence, or substance abuse.\n13. Presence of any life-threatening disease, medical condition, or organ system dysfunction that, in the investigator's opinion, may affect patient safety or compliance with study procedures.\n14. Other conditions that, in the investigator's opinion, make the patient unsuitable for participation in this clinical trial.",{"count":433,"type":21},[24],"To evaluate the efficacy and safety of Genetic subtype-matched targeted therapy in the treatment of treatment-naive diffuse large B-cell lymphoma with TP53 mutation.",[188],[536,650,651,652],"orelabrutinib","Diffuse Large B-Cell Lymphoma","TP53 mutation","2026-03-24",{"date":655,"type":32},"2026-03-30",{"date":657,"type":32},"2026-01-01",{"date":659,"type":21},"2027-12-31",{"name":38,"class":39},{"id":662,"slug":663,"hasResults":12,"nctId":664,"briefTitle":665,"officialTitle":666,"acronym":667,"eligibilityCriteria":668,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":669,"targetDuration":4,"studyType":22,"phases":670,"briefSummary":671,"conditions":672,"keywords":675,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":653,"lastUpdatePostDateStruct":686,"startDateStruct":687,"completionDateStruct":689,"leadSponsor":691,"locationsCount":693},"100631548","phase-2-nexcar19-talikabtagene-autoleucel-in-relapsedrefractory-b-cell-malignancies-nexcar19-100631548","NCT07502118","NexCAR19 (Talikabtagene Autoleucel) in Relapsed\u002FRefractory B-Cell Malignancies (NexCAR19)","An Open-Label, Multicenter Phase 2-3 Clinical Study of Anti-CD19 Chimeric Antigen Receptor T Cells (Talikabtagene Autoleucel) in Patients With Relapsed\u002FRefractory B-Cell Malignancies (NexCAR19)","NexCAR19","Inclusion Criteria\n\n1. All participants must meet Inclusion Criteria 1-13.\n\n   Additionally:\n2. High-grade lymphoma subjects must meet Criteria 14-18.\n3. Other B-cell lymphoma subjects must meet Criteria 19-24.\n4. B-ALL subjects must meet Criteria 25-29.\n\nGeneral Inclusion Criteria (Applicable to All Cohorts)\n\n1. Age ≥18 years.\n2. Patients approved for leukapheresis by the CAR-T cell treatment council.\n3. ECOG performance status \\\u003C2.\n4. Life expectancy ≥12 weeks.\n5. Renal Function: Estimated creatinine clearance ≥60 mL\u002Fmin (Cockcroft-Gault) → fludarabine\u002Fcyclophosphamide lymphodepletion.\n\n   In lymphoma cohort patients with creatinine clearance 30-60 mL\u002Fmin, bendamustine may be used as an alternative due to cumulative fludarabine toxicity and neurotoxicity risk.\n6. Liver Function:\n\n   1. ALT and AST ≤3 × ULN unless attributable to underlying malignancy.\n   2. Total bilirubin ≤2 × ULN except in Gilbert syndrome, isolated unconjugated hyperbilirubinemia, or if attributable to underlying malignancy.\n7. Hemodynamically stable with LVEF ≥45% (confirmed by echocardiography or MUGA scan).\n8. Baseline oxygen saturation \\>92% on room air.\n9. ANC ≥500\u002FµL (may be waived if cytopenia due to underlying malignancy at investigator discretion).\n10. Platelet count ≥50,000\u002FµL (may be waived if cytopenia due to underlying malignancy at investigator discretion).\n11. Negative serum or urine pregnancy test (within 24 hours prior to conditioning therapy) in women of childbearing potential; also negative prior to leukapheresis.\n12. Sexually active patients (women of childbearing potential and all men) must use highly effective contraception for ≥12 months after CAR-T infusion.\n13. Written informed consent provided.\n\n    High-Grade Lymphoma - Additional Inclusion Criteria (14-18)\n14. Histologically confirmed previously treated:\n\n    1. Diffuse large B-cell lymphoma (DLBCL)\n    2. Primary mediastinal B-cell lymphoma\n    3. Transformed indolent B-cell lymphoma\n    4. Follicular lymphoma Grade 3B\n    5. High-grade B-cell lymphoma\n15. Chemotherapy-refractory disease defined as:\n\n    1. Primary refractory disease\n    2. Best response to last chemotherapy = PD or SD (biopsy confirmed)\n    3. Progression\u002Frelapse ≤12 months after autologous SCT\n    4. Relapse ≤12 months after first-line CR (biopsy confirmed)\n    5. Relapse beyond 12 months if auto-SCT not feasible\n16. Not eligible for or unwilling to undergo autologous SCT.\n17. Must have received anti-CD20 monoclonal antibody and anthracycline-containing regimen. Transformed lymphoma subjects must have received ≥2 prior systemic lines.\n18. Measurable disease per International Working Group (IWG) criteria.\n\n    Other B-Cell Lymphomas - Additional Inclusion Criteria (19-24)\n19. Histologically confirmed:\n\n    1. Mantle Cell Lymphoma (Cyclin D1 overexpression or t(11;14))\n    2. Follicular Lymphoma Grade I-IIIA\n    3. Marginal Zone Lymphoma\n20. Relapsed or refractory disease:\n\n    1. MCL: ≤5 prior regimens including:\n\n       * Anthracycline or bendamustine\n       * Anti-CD20 antibody\n       * BTK inhibitor (ibrutinib or acalabrutinib; intolerance allowed)\n    2. FL\u002FMZL: Progression after ≥2 combination chemoimmunotherapy regimens (single-agent CD20 or splenectomy not counted).\n21. Radiologically measurable disease at screening\n\n    1. per revised IWG (Cheson 2007): ≥1 measurable lesion\n    2. Previously irradiated lesions measurable only if progression documented\n    3. If only nodal disease: ≥1 node ≥2 cm\n22. No known active CNS lymphoma involvement.\n23. Prior therapy toxicities resolved to ≤Grade 1 (except alopecia).\n24. Prior autologous HCT, POD24 status, and prior PI3K inhibitor therapy allowed.\n\n    B-Cell Acute Lymphoblastic Leukemia (B-ALL) - Additional Inclusion Criteria (25-29)\n25. Relapsed\u002FRefractory B-ALL meeting one of:\n\n    1. Primary refractory disease\n    2. First relapse ≤12 months\n    3. ≥2 prior systemic lines\n    4. Post-allogeneic SCT relapse (≥100 days post-transplant; off immunosuppression ≥4 weeks)\n    5. Ph+ disease:\n\n       * TKI intolerance\n       * Relapsed\u002Frefractory after ≥2 TKIs\n       * No alternative TKI option\n    6. Ineligible for allogeneic SCT due to\n\n       * comorbidity,\n       * conditioning contraindication,\n       * no donor,\n       * prior SCT,\n       * or refusal (documented).\n26. Morphological bone marrow disease.\n27. CD19 tumor expression documented within 3 months (BM or PB by flow cytometry).\n28. Absolute lymphocyte count ≥100\u002FµL.\n29. ≥3 half-lives elapsed since prior immune checkpoint inhibitor or stimulatory therapy\n\nExclusion Criteria\n\n1. All participants must meet Exclusion Criteria 1-14.\n\n   Additionally:\n2. High-grade lymphoma: 15-22\n3. Low-grade lymphoma: 23-24\n4. B-ALL: 25\n\nGeneral Exclusion Criteria (All Cohorts)\n\n1. Uncontrolled life-threatening infection (e.g., positive blood culture ≤72h before infusion).\n2. HIV positive.\n3. Active HBV replication or active HCV (RNA positive).\n4. Unstable angina or MI within 6 months.\n5. Uncontrolled cardiac arrhythmia.\n6. Concurrent malignancy except adequately treated non-melanoma skin cancer, in situ carcinoma (≥3 years disease-free), or completely resected malignancy in CR ≥3 years.\n7. Pregnant or breastfeeding.\n8. Hypersensitivity to CAR-T product excipients.\n9. Active autoimmune\u002Finflammatory neurologic disorders.\n10. Primary immunodeficiency.\n11. Short-acting leukemia\u002Flymphoma therapies must be stopped \\>72h before leukapheresis and infusion.\n12. Burkitt lymphoma\u002Fleukemia.\n13. Steroids must be discontinued \\>72h prior (\\\u003C12 mg\u002Fm²\u002Fday hydrocortisone equivalent allowed).\n14. Investigator deems subject unable to comply.\n\n    High-Grade Lymphoma - Additional Exclusion (15-22)\n15. Active CNS involvement.\n16. Prior allogeneic HSCT.\n17. Systemic immunosuppressives not discontinued ≥1 weeks before leukapheresis\u002Finfusion.\n18. Anti-proliferative therapy not stopped ≥1 weeks prior.\n19. Cytotoxic drugs not stopped ≥1 week prior.\n20. A minimum interval of ≥4 weeks is required between donor lymphocyte infusion (DLI) and leukapheresis, and ≥4 weeks between DLI and CAR-T cell infusion. This requirement applies to prior antibody-based therapies, including anti-CD20, anti-CD22, anti-CD79a, and similar agents.\n21. CNS prophylaxis not stopped \\>1 week prior.\n22. Radiation not stopped ≥2 days before leukapheresis and ≥1 week before infusion.\n\n    Low-Grade Lymphoma - Additional Exclusion (23-24)\n23. Live vaccine ≤6 weeks before conditioning.\n24. Tumor mass effect requiring urgent treatment.\n\n    B-ALL - Additional Exclusion (25)\n25. Acute graft-versus-host disease (GVHD) of Grade II-IV according to the Glucksberg criteria or Grade B-D according to the IBMTR index; or acute or chronic GVHD requiring systemic treatment within 4 weeks prior to enrollment.",{"count":575,"type":21},[24,264],"The NexCAR19 study is a national, open-label, multicenter Phase 2-3 clinical trial designed to evaluate the efficacy and safety of the anti-CD19 chimeric antigen receptor (CAR) T-cell product, Talikabtagene Autoleucel, in patients with relapsed\u002Frefractory B-cell malignancies, including B-cell Acute Lymphoblastic Leukemia (B-ALL) and Non-Hodgkin Lymphoma. The study is supported by the Presidency of Turkish Health Institutes (TÜSEB) and will be conducted at four centers.\n\nThis therapy is based on collecting the patient's own T cells, genetically modifying them in a laboratory to recognize the CD19 antigen, and reinfusing them into the patient. The goal is to target leukemia or lymphoma cells and achieve disease control.\n\nThe primary objective is to assess the overall response rate at Day 28 after infusion and to evaluate the safety profile of the treatment. Secondary objectives include assessment of complete response rate, duration of response, overall survival, and progression-free survival, as well as the frequency and severity of cytokine release syndrome (CRS), neurotoxicity (ICANS), and other treatment-related adverse events. In addition, the in vivo persistence and immunological effects of CAR-T cells will be evaluated.\n\nEligible patients must be 18 years of age or older, have an adequate performance status, sufficient organ function, and meet disease-specific eligibility criteria. Key exclusion criteria include active severe infection, uncontrolled cardiac disease, active central nervous system involvement (where applicable), HIV or active hepatitis infection, pregnancy, and severe immunodeficiency.\n\nThe treatment process includes leukapheresis for cell collection, administration of lymphodepleting chemotherapy if required, followed by a single infusion of CAR-T cells. Patients will be closely monitored after infusion, particularly during the early period, and both early and late adverse events, as well as treatment response, will be regularly assessed.\n\nA total of 40 patients are planned to be enrolled. The overall clinical follow-up period, including short- and long-term monitoring, is expected to last approximately 30 months. Data will be analyzed using appropriate statistical methods.",[673,674,188,352,324],"Relapsed\u002FRefractory B-cell Acute Lymphoblastic Leukemia (B-ALL)","Relapsed\u002FRefractory Non-Hodgkin Lymphoma",[676,677,381,678,679,385,680,681,682,683,684,685],"Relapsed\u002FRefractory B-Cell Malignancies","B-Cell Acute Lymphoblastic Leukemia (B-ALL)","High-Grade Lymphoma","Low-Grade Lymphoma","CAR-T Cell Therapy","Talikabtagene Autoleucel","Autologous T Cells","Adoptive Cell Therapy","Cytokine Release Syndrome (CRS)","ICANS",{"date":655,"type":32},{"date":688,"type":32},"2025-09-11",{"date":690,"type":21},"2030-01-01",{"name":692,"class":520},"Health Institutes of Turkey",4]