[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"high-grade-b-cell-lymphoma-hgbcl\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:high-grade-b-cell-lymphoma-hgbcl":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,73,106,134,175,192,208],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":35,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"100054189","phase-2-daly-ii-usa-mb-cart20191-for-dlbcl-100054189",false,"NCT04792489","DALY II USA\u002F MB-CART2019.1 for DLBCL","A Multi-center Single Arm Phase II Study to Evaluate the Safety and Efficacy of Genetically Engineered Autologous Cells Expressing Anti-CD20 and Anti-CD19 Specific Chimeric Antigen Receptor in Subjects With Relapsed and\u002For Refractory Diffuse Large B Cell Lymphoma","Inclusion Criteria:\n\n* Histologically confirmed B-cell non-Hodgkin's lymphoma:\n\n  * DLBCL cohort (both cohorts)\n* DLBCL or associated subtype, defined by WHO 2016 classification\n* DLBCL not otherwise specified (NOS)\n* High-grade B cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements\n* High-grade B cell lymphoma (NOS)\n* Primary mediastinal (thymic) large B cell lymphoma\n* Transformed lymphoma (e.g., transformed follicular, or marginal zone lymphoma, follicular lymphoma (FL Grade 3)\n\n  o CNS cohort\n* B-cell primary or secondary central nervous system lymphoma (PCNSL or SCNSL)\n\n  o Mantle Cell Lymphoma (MCL) cohort\n* Histologically confirmed MCL determined by overexpression of cyclin D1 or presence of t(11;14) (q13; q32) translocation\n\n  o Richter's Transformation (RT) cohort\n* Histologically confirmed RT to a diffuse large B-cell lymphoma (DLBCL) subtype from underlying CLL (clonally related)\n* Relapsed or refractory disease is defined for DLBCL (and associated subtypes) population as:\n\nFor DLBCL cohort (after receiving at least two prior lines of therapy): persistent disease after failure of 2 or more lines of chemotherapy including rituximab or equivalent and anthracycline and either after failed ASCT, or ineligible, not intended for or not consenting to ASCT\n\n* Chemotherapy-refractory disease (applies to all cohorts) is defined as persistent disease after last line of therapy or relapsed or persistent disease after prior ASCT for lymphoma\n* Disease relapse in subjects without prior ASCT is defined as relapse of disease after the last dose of most recent therapy regimen\n\nFor disease specific cohorts added after the initial DLBCL cohort the definition of relapsed\u002Frefractory disease is as described below:\n\nCNS cohort: Subjects with relapsed\u002Frefractory PCNSL that have failed (or unable to tolerate) at least first-line therapy.\n\n* First-line therapy is defined as either high dose methotrexatebased therapy, temozolomide, high dose cytarabine, pemetrexed, lenalidomide or Bruton tyrosine kinase (BTK) inhibitor-based therapy.\n* No contraindications for MRI evaluation\n* CNS cohort: Subjects with SCNSL must have relapsed or refractory disease after having received at least one prior line of systemic therapy\n* Prior lines of systemic therapy should include an anti-CD20 monoclonal antibody and anthracycline containing chemotherapy regimen and\u002For with or without an autologous stem cell transplant\n\nMCL cohort: Subjects with relapsed\u002Frefractory disease after at least one prior systemic treatment, that must include:\n\n* Cytotoxic rituximab \\[or equivalent\\] based chemotherapy regimen (eg, rituximab bendamustine, R-CHOP, R-DHAP, R-ARA-C) AND\n* BTK inhibitor\n\nRT cohort: Subject must have relapsed\u002Frefractory disease after at least one prior systemic treatment following Richter's Transformation\n\nDLBCL transplant ineligible 2nd cohort: subject must have failure of first-line chemotherapy (including rituximab or equivalent and anthracycline).\n\n* For this cohort subjects are considered transplant ineligible if they meet one of the following criteria:\n* Age ≥70 years\n* ECOG status is 2 at screening\n* Impaired pulmonary function: diffusing capacity of the lung for carbon monoxide \\[DLCO\\] ≤ 60% adjusted for gender-specific hemoglobin concentration (Coates formula)\n* Impaired cardiac function: left ventricular ejection fraction (LVEF) \\\u003C 50%; must be assessed by echocardiogram or multiple uptake gated acquisition (MUGA) scan performed within 4 weeks of determination of eligibility\n* Impaired renal function: calculated creatinine clearance (Cockcroft and Gault) \\\u003C 60 mL\u002Fmin\n* Impaired hepatic function: aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) \\> 2 x upper limit of normal (ULN)\n\nIn addition, all subjects must have:\n\n* Age ≥18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status that is either 0 or 1 at screening. ECOG performance status of 2 at screen is allowed if the decrease in performance status is due to lymphoma\n\n  * Subjects in DLBCL transplant-ineligible 2nd-line cohort with ECOG performance status of 2, regardless of attribution, will be allowed for inclusion\n* Measurable disease will be assessed by FDG-PET\u002FCT in systemic lymphoma . and by brain\u002Fspine MRI for CNS disease\n* Subject must have a tumor biopsy sample (at least 16 unstained slides of tissue or tissue block) from the most recent relapse available prior to MB-CART2019.1 infusion. If medically not feasible to obtain a biopsy from the most recent relapse and for cases when the amount of tissue is limited, the sponsor should be consulted, to confirm adequacy of the sample for study required analyses\n* No clinical suspicion of central nervous system (CNS) lymphoma (not applicable to CNS cohort)\n\n  * Subjects in DLBCL transplant-ineligible 2nd-line cohort with SCNSL will be allowed for inclusion\n* If the subject has history of CNS disease (not applicable to CNS cohort), then he\u002Fshe must have no signs or symptoms of CNS disease, have no active disease on magnetic resonance imaging (MRI), have no large cell lymphoma present in cerebral spinal fluid (CSF), regardless of the number of white blood cells (WBCs)\n* If has history of cerebral vascular accident (CVA), the CVA event must be greater than 12 months prior to leukapheresis. Any neurological deficits must be stable\n* A creatinine clearance (as estimated by direct urine collection or Cockcroft-Gault Equation) \\> 45mL\u002Fmin\n* Cardiac ejection fraction (EF) ≥ 45% as determined by an echocardiogram (ECHO) or Multigated Radionuclide Angiography (MUGA)\n* Subjects in DLBCL transplant-ineligible 2nd-line cohort with a lower ejection fraction of \\> 40% will be allowed for inclusion\n* Resting O2 saturation \\>90% on room air\n* Serum alanine aminotransferase (ALT) \u002F aspartate aminotransferase (AST)\\\u003C5 times the Upper Limit of Normal (ULN) for age\n* Total bilirubin \\\u003C1.5 mg\u002Fdl, except in individuals with Gilbert's syndrome\n* Subjects in DLBCL transplant-ineligible 2nd-line cohort with a total bilirubin of \\\u003C 2.0 mg\u002FdL will be allowed for inclusion\n* Absolute neutrophil count (ANC) \\> 1000\u002FμL\n* Absolute lymphocyte count \\> 100\u002FμL\n* Platelet count \\> 50,000\u002FµL\n* Estimated life expectancy of more than 3 months other than primary disease\n\nExclusion Criteria:\n\n* Primary CNS lymphoma (not applicable to CNS cohort)\n* Richter's transformed DLBCL arising from chronic lymphocytic leukemia (CLL) (not applicable to RT cohort)\n* Unable to give informed consent\n* Known history of infection with human immunodeficiency virus (HIV) or active hepatitis B (HBsAg positive). If there is a history of treated hepatitis B or hepatitis C, the viral load must be quantitative polymerase chain reaction (PCR) negative; antiviral prophylaxis is required if HBsAg negative and anti-HBc positive\n* Known history of infection with hepatitis C virus (anti-HCV positive) unless viral load is undetectable per quantitative PCR and\u002For nucleic acid testing.\n* Pharmacologically uncontrolled seizures.\n* Known history or presence of autoimmune CNS disease, such as multiple sclerosis, optic neuritis, or other immunologic or inflammatory disease\n* Presence of CNS disorder that, in the judgment of the Investigator, may impair the ability to evaluate neurotoxicity. For CNS Cohort:\n\n  * For CNSL and DLBCL transplant-ineligible 2nd-line cohort patients that have a CNS lesion(s): Midline shift on MRI or Abnormal high CSF opening pressure and or CSF protein ≥150 mg\u002FdL Recent (within 3 months) whole brain radiotherapy (WBRT) are exclusionary\n* Active systemic fungal, viral, or bacterial infection\n* Pregnant or breast-feeding woman\n* Previous or concurrent malignancy with the following exceptions:\n\n  * Adequately treated basal cell or squamous cell carcinoma (adequate wound healing required prior to study entry)\n  * In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 2 years prior to the study\n  * Adequately treated breast or prostate carcinoma on hormonal therapies such as Lupron or tamoxifen and in clinical remission of ≥ 2 years\n  * A primary malignancy which has been completely resected \u002F treated with curative intent and in complete remission of ≥ 2 years\n* Severely immunocompromised subjects e.g., due to current treatment of non-neurologic autoimmune disease (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus).\n* Medical condition requiring prolonged use of systemic corticosteroids equivalent to prednisone \\>10 mg\u002Fday. For CNS cohort: Up to 2 mg\u002Fday dexamethasone (or equivalence) may be allowed at any time, higher doses allowed up to 7 days prior to apheresis or after apheresis until lymphodepletion.\n* History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 6 months of enrollment.\n* Concurrent radiotherapy (allowed up to time of lymphodepletion). For prior systemic therapy, at least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed at the time of scheduled leukapheresis.\n* Baseline dementia that would interfere with therapy or monitoring, determined using Immune Effector Cell-Associated Encephalopathy (ICE) Assessment at baseline.\n* History of severe immediate hypersensitivity reaction to any of the agents used in this study.\n* Refusal to participate in additional lentiviral gene therapy long-term follow-up (LTFU) protocol\n* Prior CAR-T therapy for any indication or systemic gene modifying therapy for B-cell lymphoma\n* Prior allogeneic stem cell transplant for any indication\n* Prior Bispecific T cell engaging (BITE) antibodies for cancer therapy\n* Prior T cell receptor-engineered T cell therapy","ALL","18 Years",{"count":19,"type":20},315,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","DALY II USA is a phase II, multi-center, single arm study to evaluate the efficacy, safety, and pharmacokinetics of zamtocabtagene autoleucel (MB-CART2019.1) in patients with relapsed and\u002For refractory B cell lymphoma (BCL). Cohorts include subjects with diffuse large B-cell lymphoma (DLBCL) after receiving at least 2 lines of therapy, primary or secondary central nervous system (CNS) lymphoma (PCNSL) and (SCNSL) after receiving at least one line of therapy, mantle cell lymphoma (MCL) and Richter's transformation (RT) after receiving at least one line of therapy, and DLBCL transplant-ineligible after receiving at least one line of therapy.",[26,27,28,29,30,31,32,33,34],"Refractory Diffuse Large B Cell Lymphoma (DLBCL)","Relapsed Diffuse Large B Cell Lymphoma","High Grade B-cell Lymphoma (HGBCL)","Primary Mediastinal B-cell Lymphoma (PMBCL)","Transformed Lymphoma","Central Nervous System Lymphoma","Mantle Cell Lymphoma (MCL)","Richter Transformation","Transplant-ineligible 2nd Line DLBCL",[36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59],"CD19\u002FCD20-directed CAR-T Cells","Zamtocabtagene autoleucel","B-Cell Non-Hodgkin Lymphoma","Primary Central Nervous System Lymphoma","Secondary Central Nervous System Lymphoma","NHL","PCNSL","SCNSL","Chimeric Antigen Receptor","CAR","CAR-T Cell","Autologous T Cell Therapy","Central Nervous System Neoplasms","Lymphoma","Lymphoma, Non-Hodgkin","Lymphoma, B-Cell","Lymphoma, Large B-Cell, Diffuse","MCL","RT","CLL","Immunotherapy","T cells","T cell infusion","transplant-ineligible 2nd line DLBCL","RECRUITING","2026-07-09",{"date":63,"type":64},"2026-07-13","ACTUAL",{"date":66,"type":64},"2021-05-25",{"date":68,"type":20},"2028-12-31",{"name":70,"class":71},"Miltenyi Biomedicine GmbH","INDUSTRY",32,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":86,"conditions":87,"keywords":94,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100570180","phase-1-a-study-to-evaluate-the-safety-and-clinical-activity-of-gf--cart01-cd2019-car-t-cell-in-subjects-with-relapsed-or-refractory-b-cell-hematological-malignancies-100570180","NCT06703892","A Study to Evaluate the Safety and Clinical Activity of GF- CART01 (CD20\u002F19 CAR T Cell) in Subjects With Relapsed or Refractory B-Cell Hematological Malignancies","An Open-Label, Non-Randomized, Phase I, Prospective, Dose- Finding Study to Evaluate the Safety and Clinical Activity of GF- CART01 (CD20\u002F19 CAR T Cell) in Subjects With Relapsed or Refractory B-Cell Hematological Malignancies","CD20\u002F19 CAR T","Inclusion Criteria:\n\n1. Subjects must be of age ≥ 18 years and ≤ 70 years\n2. Subjects or their legal guardians must volunteer to participate in the study and sign the informed consent\n3. Histologically confirmed diagnosis of Diffuse Large B-Cell Lymphoma - Not Otherwise Specified (DLBCL-NOS), follicular lymphoma (FL), Primary Mediastinal Large B-cell Lymphoma (PMBCL), or High-Grade B-Cell Lymphoma (HGBCL) per the world health organization (WHO) Classification Criteria for Lymphoma (2022)\n4. Tumor cell surface expression of CD19 (+) and\u002For CD20 (+) by flow cytometry or immunohistochemistry staining\n5. Relapsed, progressive or refractory disease (defined as have not achieved a complete response) after ≥ two lines of systemic therapy, including anti-CD20 antibody and anthracycline and\u002For Relapsed, progressive or refractory disease ( defined as have not achieved a complete response) after auto-HSCT\n6. Subjects have any accessible PET-positive lesion or measurable CT-positive lesion per Lugano 2014 criteria\n7. Adequate hematologic function: absolute neutrophil count (ANC) \\> 1,000\u002FμL, absolute lymphocyte count (ALC) \\> 300\u002FμL, platelet count ≥ 75,000\u002FμL, hemoglobin ≥ 8.0 g\u002FdL\n8. Adequate hepatic function: alanine aminotransferase (ALT) ≤ 5 times upper limit of normal (ULN), aspartate transaminase (AST) ≤ 5 times ULN, total bilirubin ≤ 1.5 times ULN\n9. Adequate renal function: blood estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin\u002F1.73m2 (calculated by Modification of Diet in Renal Disease (MDRD) equation)\n10. Adequate cardiac function: echocardiogram or multigated blood pool analysis (MUGA) shows left ventricular ejection fraction (LVEF) ≥ 50%; and no clinically significant electrocardiogram (ECG) findings\n11. Adequate pulmonary function: no active infection in the lungs, blood oxygen saturation in indoor air ≥ 92%\n12. No clinically significant pleural effusion determined by the investigators\n13. Estimated survival time ≥ 3 months\n14. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2\n15. Willingness and ability to comply with protocol-stated requirements, instructions, and restrictions in the investigator's judgement\n\nExclusion Criteria:\n\n1. Previously treated with any CAR T cell product or allogenic hematopoietic stem cell transplant (HSCT)\n2. Known or suspected allergy, hypersensitivity, or intolerance to any ingredients of the investigational product (IP)\n3. Known medical history or possible risk for taking contrast agent(s) for positron emission tomography (PET) and\u002For computed tomography (CT) scan\n4. Received any other investigational product, cell therapy, or gene therapy within 12 weeks prior to the leukapheresis\n5. Received any tyrosine kinase inhibitor within 2 weeks prior to the leukapheresis\n6. Received any systemic steroid, immunotherapy (such as immune checkpoint inhibitors, T- cell transfer therapies, monoclonal antibodies), or chemotherapy within 4 weeks prior to the leukapheresis\n7. Received any live vaccine from 2 weeks prior to the leukapheresis\n8. Subjects with human immunodeficiency virus (HIV), syphilis, Hepatitis B or C infection: HIV-1 and HIV-2 antibody positive, syphilis antibody positive, both hepatitis B virus (HBV) DNA and hepatitis B core (HBc) antibody positive, or hepatitis C virus (HCV) antibody positive\n9. Subjects with atrial or ventricular involvement by B-cell malignancies\n10. Subjects with tumor mass requiring urgent treatment within 8 weeks prior to the leukapheresis, such as ileus, tumor lysis syndrome, or vascular compression\n11. Subjects with severe disease or other uncontrolled diseases, such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia (urgent intervention indicated, life- threatening consequences, or hemodynamic compromise), cardiac angioplasty or stenting, unstable angina, cerebral thrombosis, cerebral hemorrhage, hypertension (systolic blood pressure ≥ 140 mmHg and\u002For diastolic blood pressure ≥ 90 mmHg)\n12. Unstable pulmonary embolism, deep venous embolism, or other major arterial\u002Fvenous thromboembolism events that occurred within 6 weeks prior to the leukapheresis. If subjects receive anticoagulant therapy, the treatment dose and frequency must be stable for more than 14 weeks prior to the leukapheresis\n13. History of craniocerebral trauma, disturbance of consciousness, epilepsy, cerebrovascular ischemia, cerebrovascular hemorrhagic diseases, dementia, cerebellar disease, or any autoimmune disease with central nervous system (CNS) involvement\n14. Female subject of childbearing potential who: a. Has positive pregnancy test result; or b. Is lactating\n15. Female subjects of childbearing potential, or male subject with female spouse\u002Fpartner of childbearing potential, who refuses to adopt at least one form of birth control from the date of signing informed consent to 12 months after GF-CART01 infusion. Acceptable forms of birth control include: a. Established use of oral, injected or implanted hormonal methods of contraception b. Placement of an intrauterine device (IUD) or intrauterine system (IUS) c. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical\u002Fvault caps)\n16. Any following situations that the investigators believe are not suitable for this trial and\u002For may increase the risk for subjects or interfere with the results of the study a. With severe active infections (except simple urinary tract infection and bacterial pharyngitis) b. With active central nervous system involvement by lymphoma, malignant cells in cerebrospinal fluid c. History of brain metastasis d. With uncontrolled malignancies e. Any toxicities due to prior therapy f. With any uncontrolled illness or a history of any illness","70 Years",{"count":83,"type":20},18,[85],"PHASE1","This is a Phase I, prospective, dose-finding study to evaluate the safety, persistence, and clinical activity of GF-CART01 in subjects aged 18-70 with relapsed or refractory (R\u002FR) B-cell hematological malignancies and failure of two-line or more standard chemotherapies or auto-hematopoietic stem cell transplantation (HSCT).This study is a traditional 3+3 dose-escalation design to observe dose-limiting toxicity (DLT), establish the maximum tolerated dose(MTD)\u002Frecommended phase 2 doses (RP2D), and preliminary efficacy of GF-CART01. RP2D may equal to or lower than MTD",[88,89,90,91,92,93],"Diffuse Large B Cell Lymphoma Relapsed","Diffuse Large B Cell Lymphoma Refractory","Follicular Lymphoma ( FL)","Primary Mediastinal Large B-Cell Lymphoma-Refractory","Primary Mediastinal Large B-Cell Lymphoma-Recurrent","High-grade B-cell Lymphoma (HGBCL)",[95],"CAR T","2026-06-10",{"date":98,"type":64},"2026-06-12",{"date":100,"type":64},"2025-06-09",{"date":102,"type":20},"2027-12",{"name":104,"class":71},"GenomeFrontier Therapeutics TW Co., Ltd.",1,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":113,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":21,"phases":116,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":124,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":105},"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":115,"type":20},29,[85],"Axatilimab + CAR-T in High-Risk Lymphoma",[119,120,93,121,122,123],"Diffuse Large B Cell Lymphoma (DLBCL)","Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma","High-Grade B-Cell Lymphoma, Nos","PMBCL","Follicular Grade 3 Lymphoma","NOT_YET_RECRUITING","2026-06-05",{"date":96,"type":64},{"date":128,"type":20},"2026-10-31",{"date":130,"type":20},"2029-12-31",{"name":132,"class":133},"Northside Hospital, Inc.","OTHER",{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":140,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":21,"phases":144,"briefSummary":146,"conditions":147,"keywords":151,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":174},"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":143,"type":20},40,[23,145],"PHASE3","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.",[148,149,150,93,90],"Relapsed\u002FRefractory B-cell Acute Lymphoblastic Leukemia (B-ALL)","Relapsed\u002FRefractory Non-Hodgkin Lymphoma","Diffuse Large B-Cell Lymphoma (DLBCL)",[152,153,154,155,156,157,158,159,160,161,162,163],"Relapsed\u002FRefractory B-Cell Malignancies","B-Cell Acute Lymphoblastic Leukemia (B-ALL)","Non-Hodgkin Lymphoma","High-Grade Lymphoma","Low-Grade Lymphoma","CD19","CAR-T Cell Therapy","Talikabtagene Autoleucel","Autologous T Cells","Adoptive Cell Therapy","Cytokine Release Syndrome (CRS)","ICANS","2026-03-24",{"date":166,"type":64},"2026-03-30",{"date":168,"type":64},"2025-09-11",{"date":170,"type":20},"2030-01-01",{"name":172,"class":173},"Health Institutes of Turkey","OTHER_GOV",4,{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":4,"acronym":4,"eligibilityCriteria":4,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":180,"phases":4,"briefSummary":181,"conditions":182,"keywords":4,"overallStatus":186,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":190,"locationsCount":4},"100486845","a-compassionate-use-cu-program-of-odronextamab-100486845","NCT05619367","A Compassionate Use (CU) Program of Odronextamab","EXPANDED_ACCESS","Provide compassionate use of odronextamab",[183,150,184,185],"Relapsed or Refractory (R\u002FR) Follicular Lymphoma (FL)","B-Cell Non-Hodgkin Lymphoma (NHL)","High-Grade B-Cell Lymphoma (HGBCL)","AVAILABLE","2025-12-22",{"date":189,"type":64},"2025-12-23",{"name":191,"class":71},"Regeneron Pharmaceuticals",{"id":193,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":21,"phases":197,"briefSummary":198,"conditions":199,"keywords":200,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":205,"leadSponsor":206,"locationsCount":207},"100423333","Inclusion Criteria:\n\n* Histologically confirmed B-cell non-Hodgkin's lymphoma:\n* DLBCL DLBCL or associated subtype, defined by WHO 2016 classification:\n* DLBCL not otherwise specified (NOS)\n* High-grade B cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements\n* High-grade B cell lymphoma (NOS)\n* Primary mediastinal (thymic) large B cell lymphoma\n* Transformed lymphoma (e.g., transformed follicular, or marginal zone lymphoma, follicular lymphoma (FL Grade 3)\n* CNS Cohort only: B-cell primary or secondary central nervous system lymphoma (PCNSL or SCNSL)\n* Mantle Cell Lymphoma (MCL) Cohort: Histologically confirmed MCL determined by overexpression of cyclin D1 or presence of t(11;14) (q13; q32) translocation\n* Richter's Transformation (RT) Cohort: Histologically confirmed Richter's transformation (RT) to a diffuse large B-cell lymphoma (DLBCL) subtype from underlying CLL (clonally related)\n* Relapsed or refractory disease is defined for DLBCL (and associated subtypes) population as failure of 2 or more lines of chemotherapy including rituximab or equivalent and anthracycline and either having failed autologous stem cell transplant (ASCT), or ineligible, not intended for or not consenting to ASCT\n* Chemotherapy-refractory disease is defined as persistent disease after last line of therapy or relapsed or persistent disease after prior ASCT for lymphoma\n* Disease relapse in subjects without prior ASCT is defined as relapse of disease after the last dose of most recent therapy regimen\n* CNS Cohort: Subjects with relapsed\u002Frefractory PCNSL that have failed (or unable to tolerate) at least first-line therapy.\n* No contraindications for MRI evaluation\n* CNS Cohort: Subjects with SCNSL must have relapsed or refractory disease after having received at least one prior line of systemic therapy\n* Prior lines of systemic therapy should include an anti-CD20 monoclonal antibody and anthracycline containing chemotherapy regimen and\u002For with or without an autologous stem cell transplant\n* No contraindications for MRI evaluation\n* MCL Cohort: Subjects with relapsed\u002Frefractory disease after at least one prior systemic treatment, that must include:\n* Cytotoxic rituximab-based chemotherapy regimen (eg, rituximab bendamustine, R-CHOP, R-DHAP, R-ARA-C) AND\n* BTK inhibitor\n* RT Cohort: Subject must have relapsed\u002Frefractory disease after at least one prior systemic treatment following Richter's Transformation\n* Age ≥18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status that is either 0 or 1 at screening. ECOG performance status of 2 at screen is allowed if the decrease in performance status is due to lymphoma\n* Measurable disease according to Lugano 2014 criteria for assessing FDG-PET\u002FCT in systemic lymphoma (Cheson et al, 2014). Measurable disease according to IPCG criteria will be assessed by brain\u002Fspine MRI for CNS disease\n* Subject must have a tumor biopsy sample (at least 16 unstained slides of tissue or tissue block) from the most recent relapse available prior to MB-CART2019.1 infusion. If medically not feasible to obtain a biopsy from the most recent relapse and for cases when the amount of tissue is limited, the sponsor should be consulted, to confirm adequacy of the sample for study required analyses\n* No clinical suspicion of central nervous system (CNS) lymphoma (not applicable to CNS cohort)\n* If the subject has history of CNS disease (not applicable to CNS cohort), then he\u002Fshe must have no signs or symptoms of CNS disease, have no active disease on magnetic resonance imaging (MRI), have no large cell lymphoma present in cerebral spinal fluid (CSF), regardless of the number of white blood cells (WBCs)\n* If has history of cerebral vascular accident (CVA), the CVA event must be greater than 12 months prior to leukapheresis. Any neurological deficits must be stable\n* A creatinine clearance (as estimated by direct urine collection or Cockcroft-Gault Equation) \\> 45mL\u002Fmin\n* Cardiac ejection fraction (EF) ≥ 45% as determined by an echocardiogram (ECHO) or Multigated Radionuclide Angiography (MUGA)\n* Resting O2 saturation \\>90% on room air\n* Serum alanine aminotransferase (ALT) \u002F aspartate aminotransferase (AST)\\\u003C5 times the Upper Limit of Normal (ULN) for age\n* Total bilirubin \\\u003C1.5 mg\u002Fdl, except in individuals with Gilbert's syndrome\n* Absolute neutrophil count (ANC) \\> 1000\u002FμL\n* Absolute lymphocyte count \\> 100\u002FμL\n* Platelet count \\> 50,000\u002FµL\n* Estimated life expectancy of more than 3 months other than primary disease\n\nExclusion Criteria:\n\n* Primary CNS lymphoma (not applicable to CNS cohort)\n* Richter's transformed DLBCL arising from chronic lymphocytic leukemia (CLL) (not applicable to RT cohort)\n* Unable to give informed consent\n* Known history of infection with human immunodeficiency virus (HIV) or active hepatitis B (HBsAg positive). If there is a history of treated hepatitis B or hepatitis C, the viral load must be quantitative polymerase chain reaction (PCR) negative; antiviral prophylaxis is required if HBsAg negative and anti-HBc positive\n* Known history of infection with hepatitis C virus (anti-HCV positive) unless viral load is undetectable per quantitative PCR and\u002For nucleic acid testing.\n* Pharmacologically uncontrolled seizures.\n* Known history or presence of autoimmune CNS disease, such as multiple sclerosis, optic neuritis, or other immunologic or inflammatory disease\n* Presence of CNS disorder that, in the judgment of the investigator, may impair the ability to evaluate neurotoxicity. For CNS Cohort:\n* Midline shift on MRI\n* Abnormal high CSF opening pressure and or CSF protein \\>150 mg\u002FdL Recent (within 3 months) whole brain radiotherapy (WBRT)\n* Active systemic fungal, viral, or bacterial infection\n* Pregnant or breast-feeding woman\n* Previous or concurrent malignancy with the following exceptions:\n* Adequately treated basal cell or squamous cell carcinoma (adequate wound healing required prior to study entry)\n* In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 2 years prior to the study\n* Adequately treated breast or prostate carcinoma on hormonal therapies such as Lupron or tamoxifen and in clinical remission of ≥ 2 years\n* A primary malignancy which has been completely resected \u002F treated with curative intent and in complete remission of ≥ 2 years\n* Severely immunocompromised subjects e.g., due to current treatment of non-neurologic autoimmune disease (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus).\n* Medical condition requiring prolonged use of systemic corticosteroids equivalent to prednisone \\>10 mg\u002Fday. For CNS cohort: Up to 2 mg\u002Fday dexamethasone (or equivalence) may be allowed at any time, higher doses allowed up to 7 days prior to apheresis or after apheresis until lymphodepletion.\n* History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 6 months of enrollment\n* Concurrent radiotherapy (normal tissue sparing palliative radiotherapy allowed up to time of lymphodepletion). For systemic therapy, at least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed at the time of scheduled leukapheresis.\n* Baseline dementia that would interfere with therapy or monitoring, determined using Immune Effector Cell-Associated Encephalopathy (ICE) Assessment at baseline\n* History of severe immediate hypersensitivity reaction to any of the agents used in this study\n* Refusal to participate in additional lentiviral gene therapy LTFU protocol\n* Prior CAR-T therapy for any indication or systemic gene modifying therapy for B-cell lymphoma\n* Prior allogeneic stem cell transplant for any indication\n* Prior BITE antibodies for cancer therapy\n* Prior T cell receptor-engineered T cell therapy",{"count":196,"type":20},248,[23],"DALY II USA is a phase II, multi-center, single arm study to evaluate the efficacy, safety, and pharmacokinetics of zamtocabtagene autoleucel (MB-CART2019.1) in patients with relapsed and\u002For refractory diffuse large B cell lymphoma (DLBCL) after receiving at least two lines of therapy. Additional cohorts include subjects with B-cell primary or secondary central nervous system (CNS) lymphoma (PCNSL) and (SCNSL), mantle cell lymphoma (MCL) and Richter's transformation (RT) after receiving at least one line of therapy.",[26,27,28,29,30,31,32,33],[36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58],"2025-04-21",{"date":203,"type":64},"2025-04-24",{"date":66,"type":64},{"date":68,"type":20},{"name":70,"class":71},25,{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":214,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":216,"enrollmentInfo":217,"targetDuration":4,"studyType":21,"phases":219,"briefSummary":220,"conditions":221,"keywords":225,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":5},"100586710","phase-2-study-of-loncastuximab-tesirine-in-patients-with-relapsedrefractory-diffuse-large-b-cell-lymphoma-dlbcl-or-high-grade-b-cell-lymphoma-hgbcl-following-car-t-therapy-failure-100586710","NCT06918912","Study of Loncastuximab Tesirine in Patients With Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma (DLBCL) or High-Grade B-Cell Lymphoma (HGBCL) Following CAR-T Therapy Failure","Use of LOncastuximab Tesirine in Patients With RElapsed\u002FRefractory Diffuse LargeB-Cell LYmphoma (DLBCL) or High Grade B-Cell Lymphoma (HGBCL) Who Have Progressive Disease After CAR T-cell Treatment","LORELY","Inclusion Criteria:\n\n1. Male or female patients aged ≥18 years.\n2. Ability to provide written informed consent.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n4. Histologically confirmed diagnosis of one of the following:\n\n   * Diffuse large B-cell lymphoma (DLBCL), non-Hodgkin lymphoma, or high grade B-cell lymphoma (HGBCL), including double\u002Ftriple-hit lymphomas with MYC, BCL2, and\u002For BCL6 rearrangements.\n   * Relapsed\u002Frefractory disease after prior CAR-T therapy, defined as:\n\n   Progressive disease (PD) at any time following CAR-T infusion. Partial response (PR) or stable disease (SD) at 3 months post-CAR-T infusion.\n5. Measurable disease as defined by the Lugano 2014 Classification and confirmed by PET-CT, CT, or MRI scans, as appropriate.\n6. Previous treatment with Loncastuximab Tesirina is allowed if the patient was in complete response (CR) or partial response (PR) at the time of discontinuation of the drug.\n7. Negative pregnancy test (β-HCG) for women of childbearing potential, performed within 7 days before the first dose of study drug (C1D1).\n8. Female patients of childbearing potential must agree to use highly effective contraception from the time of informed consent until at least 9 months after the last dose of Loncastuximab Tesirina. Male patients with female partners of childbearing potential must agree to use highly effective contraception from the time of informed consent until at least 6 months after the last dose of Loncastuximab Tesirina.\n9. Adequate renal, hepatic, pulmonary, and cardiac function:\n\n   Creatinine clearance ≥40 mL\u002Fmin. ALT\u002FAST ≤2.5 x ULN. Total bilirubin ≤1.5 x ULN (except for patients with Gilbert's syndrome). LVEF ≥50% (or center-specific lower limit). Oxygen saturation \\>92% at rest and no dyspnea \\>Grade 1.\n10. Adequate hematologic function:\n\nAbsolute neutrophil count ≥1.0 × 10⁹\u002FL. Hemoglobin ≥9.0 g\u002FdL. Platelets ≥50 × 10⁹\u002FL.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to Loncastuximab Tesirina or any component of the drug.\n2. Pregnant or breastfeeding women.\n3. Active second primary malignancy, except for skin cancer, non-metastatic prostate cancer, cervical carcinoma in situ, ductal or lobular carcinoma in situ of the breast, or other malignancies that are considered not to interfere with the study by the investigator.\n4. Active central nervous system (CNS) involvement, including leptomeningeal disease.\n5. Tumor mass with a diameter \\>10 cm.\n6. Positive for HIV, hepatitis B (HBV), or hepatitis C (HCV) requiring antiviral treatment.\n7. Clinically significant third-space fluid accumulation (e.g., ascites or pleural effusion requiring drainage or associated with respiratory distress).\n8. Significant comorbid conditions, including uncontrolled hypertension (BP ≥160\u002F100 mmHg), unstable angina, congestive heart failure (NYHA class III or IV), recent myocardial infarction or angioplasty within 6 months prior to screening, uncontrolled arrhythmia, poorly controlled diabetes, or severe chronic lung disease.\n9. Active autoimmune disease, motor neuropathy of autoimmune origin, or other autoimmune diseases affecting the central nervous system (CNS).\n10. History of Stevens-Johnson syndrome or toxic epidermal necrolysis.\n11. Recent chemotherapy, radiotherapy, or other anticancer treatments (within 14 days prior to study drug administration, except if approved by the Sponsor).\n12. Planned administration of a live vaccine after the first dose of study drug (C1D1).\n13. Use of any experimental drug or therapy within 14 days before the first dose of study drug (C1D1).\n14. Failure to recover from prior chemotherapy or radiation-related toxicities to ≤Grade 1 (CTCAE v5.0) before screening.\n15. Any other disease, anomaly, or medical condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study or pose a risk to the patient.","99 Years",{"count":218,"type":20},50,[23],"The goal of this clinical trial is to evaluate whether the drug Loncastuximab Tesirine can treat patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) or High-Grade B-Cell Lymphoma (HGBCL) who have not responded to or have had a relapse after CAR-T therapy. The main question it aims to answer is:\n\n* Can Loncastuximab Tesirine improve the overall response rate (ORR) in patients who have failed CAR-T therapy?\n* What are the safety and potential side effects of Loncastuximab Tesirine in this patient group?\n\nThis is a single-arm clinical trial, meaning all participants will receive the same treatment and there will be no comparison group. Researchers will focus on evaluating the effectiveness of the drug in helping patients achieve a response to treatment, and they will also assess the safety of the treatment.\n\nParticipants will:\n\n* Be treated with Loncastuximab Tesirine through an intravenous (IV) infusion every 3 weeks for up to 8 cycles.\n* Undergo regular assessments to monitor the response to treatment, including PET-CT scans and blood tests to check for markers of the disease.\n* Be asked to provide informed consent before beginning the study and agree to follow the study procedures, including having biopsies performed to analyze biomarkers before starting treatment.\n* Be followed for up to 2 years after completing the treatment to track their progress and response.\n\nThis study aims to help doctors understand if Loncastuximab Tesirine can offer a new treatment option for patients who have not responded to CAR-T therapy and have limited options for further treatment. The trial will also provide more information on how to manage the safety of this treatment for these patients.",[222,93,223,224],"Diffuse Large B-Cell Lymphoma","B-Cell Lymphoma Treatment","Relapsed or Refractory Lymphoma",[226,227],"Antibody-Drug Conjugates","Loncastuximab Tesirine","2025-04-02",{"date":230,"type":64},"2025-04-09",{"date":232,"type":64},"2023-06-16",{"date":234,"type":20},"2027-06",{"name":236,"class":133},"Istituto Clinico Humanitas"]