[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsed-diffuse-large-b-cell-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsed-diffuse-large-b-cell-lymphoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,73,99,115],{"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":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":98},"100551311","phase-2-epcoritamab-car-t-cells-for-large-b-cell-lymphomas-100551311","NCT06458439","Epcoritamab-CAR T Cells for Large B-cell Lymphomas","Phase IIa Trial to Evaluate Epcoritamab Administered Before and After CAR-T Cell Therapy in Patients With Relapsed or Refractory Large B-cell Lymphomas","Inclusion Criteria:\n\n* Age \\> 18 years\n* Subject must be able and willing to provide informed consent. In the case where the patient is incapacitated or not otherwise capable, a legally authorized representative (or decision maker when there is not an advanced directive in place) must be willing to provide informed consent on behalf of the patient.\n* Able to comply with the study protocol, in the investigator's judgment\n* ECOG PS of 0 - 2\n* Pathology report confirming eligible diagnosis\n* Documented CD20+ tumor cells on most recent biopsy\n* Patients will have failed to respond to frontline standard of care therapy containing an anthracycline and anti-CD20 antibody\n* Patients will be eligible and consent to be treated with a \"commercially available\" anti-CD19, 4-1BB, CD3zeta CAR-T cell therapy or anti-CD19, CD28, CD3zeta CAR T cell therapy (for example, tisagenlecleucel, lisocabtagene maraleucel, or axicabtagene maraleucel)\n* Patients must have a PET\u002FCT scan (preferred), diagnostic CT scan, or MRI with at least one bi-dimensionally measurable lesion (≥ 1.5 cm for nodal lesions or ≥ 1cm for extra-nodal lesions in largest dimension by low-dose computerized tomography \\[CT\\] scan with FDG-uptake ≥ liver)\n* Adequate laboratory studies\n* Resolution of toxicities from prior therapy to a grade that does not contraindicate trial participation in the opinion of the investigator\n* Ability and willingness to take proper contraceptive precautions\n\nExclusion Criteria:\n\n* Inability or unwillingness of the patient or legally authorized representative (or decision-maker when there is not an advanced directive in place) to provide informed consent.\n* Prior solid organ transplantation\n* Primary central nervous system (CNS) lymphoma or active secondary CNS involvement by lymphoma at screening as confirmed by magnetic resonance imaging (MRI)\u002Fcomputed tomography (CT) scan (brain) or, if clinically indicated, by lumbar puncture.\n* History of autoimmune disease or other diseases resulting in permanent immunosuppression or requiring chronic immunosuppressive therapy (see Exclusion Criteria 5a), with the following exceptions:\n\n  1. Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone\n  2. Patients with a history of lymphoma-related immune thrombocytopenic purpura or autoimmune hemolytic anemia in remission may be eligible for this study if approved by the Regulatory Sponsor and Principal Investigator\n  3. Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\n\n  i. Rash must cover \\\u003C 10% of body surface area ii. Disease is well controlled at baseline and requires only low-potency topical corticosteroid iii. No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or corticosteroids (\\> 20 mg\u002Fday prednisone or equivalent for \\> 2 weeks) within the previous 3 months d. rheumatoid arthritis or similar autoimmune\u002Frheumatic conditions\n* Systemic immunosuppressive medications (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents). However, the following are permitted:\n\n  1. If receiving glucocorticoid treatment at screening, must be a maximum daily dose of prednisone 10 mg (or equivalent) and a total of no more than 140 mg over the last 14 days prior to the first dose of epcoritamab, unless for disease control.\n  2. Patients who received a single dose of a systemic immunosuppressant medications (e.g., single dose of dexamethasone for nausea or B symptoms) may be enrolled\n  3. The use of inhaled corticosteroids is permitted\n  4. The use of mineralocorticoids for management of orthostatic hypotension is permitted\n  5. The use of physiologic doses of corticosteroids (\\\u003C 20 mg\u002Fday of prednisone or equivalent) for uses such as management of adrenal insufficiency is permitted\n* Known past or current malignancy, other than inclusion diagnoses, except for:\n\n  1. Cervical carcinoma of Stage 1B or less.\n  2. Adequately resected, non-metastatic basal cell or squamous cell skin carcinoma.\n  3. Non-invasive, superficial bladder cancer.\n  4. Prostate cancer with a current PSA level \\\u003C0.1 ng\u002FmL.\n  5. Patients with a malignancy that has been treated with curative intent will also be enrolled if that malignancy is in remission prior to first dose of epcoritamab\n* Known clinically significant cardiovascular disease\n* Patients with the following active infection(s) could have increased risks for toxicity if treated with bispecific antibody therapy, thus patient will be excluded if:\n\n  1. Positive serologic or PCR test results for acute or chronic HBV infection. Patients whose HBV infection status cannot be determined by serologic test results (www.cdc.gov\u002Fhepatitis\u002Fhbv\u002Fpdfs\u002Fserologicchartv8.pdf) must be negative for HBV by PCR to be eligible for study participation. Patients with a history of hepatitis B who are negative for HBV by PCR, will not be excluded but will be placed on suppressive antiviral therapy\n  2. Acute or chronic HCV infection. Patients who are positive for HCV antibody must be negative for HCV by PCR to be eligible for study participation. Patients with a history of hepatitis C who have been adequately treated (negative PCR) will not be excluded.\n  3. Positive serologic or RT-PCR test results for HIV infection.\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major documented infection requiring treatment with IV antibiotics or hospitalization within 2 weeks of enrollment. Empiric or prophylactic antibiotics administered during neutropenia or neutropenic fever without microbiologic evidence of infection do not exclude patients.\n* Clinically significant pulmonary disease (e.g., bronchospasm and\u002For obstructive pulmonary disease) that requires chronic oxygen or corticosteroid use \\> 20 mg mg\u002Fday prednisone or equivalent\n* Uncontrolled seizure disorder\n* Exposure to live or live attenuated vaccine within 4 weeks prior to signing ICF\n* Pregnancy or breast feeding\n* Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results",{"count":81,"type":20},31,[23],"This study investigates the feasibility and efficacy of epcoritamab treatment before CAR T cells. This study also investigates if, when patients have residual lymphoma after CAR T cells, epcoritamab can help to effectively treat that lymphoma.",[50,27,85,86,87],"Refractory Diffuse Large B-cell Lymphoma","High-grade B-cell Lymphoma","Transformed Indolent Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma","2026-05-22",{"date":90,"type":64},"2026-05-27",{"date":92,"type":64},"2024-09-24",{"date":94,"type":20},"2027-12",{"name":96,"class":97},"Abramson Cancer Center at Penn Medicine","OTHER",1,{"id":100,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":21,"phases":104,"briefSummary":105,"conditions":106,"keywords":107,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":112,"leadSponsor":113,"locationsCount":114},"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":103,"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":110,"type":64},"2025-04-24",{"date":66,"type":64},{"date":68,"type":20},{"name":70,"class":71},25,{"id":116,"slug":117,"hasResults":11,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":21,"phases":125,"briefSummary":126,"conditions":127,"keywords":129,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":144},"100433168","phase-2-dpx-survivac-and-pembrolizumab-with-and-without-intermittent-low-dose-cyclophosphamide-in-subjects-with-relapsedrefractory-diffuse-large-b-cell-lymphoma-100433168","NCT04920617","DPX-Survivac and Pembrolizumab With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma","A Phase 2b, Open-label, Multicenter, Randomized Parallel-Group, Two-Stage, Study of an Immunotherapeutic Treatment DPX-Survivac and Pembrolizumab, With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma (VITALIZE)","VITALIZE","Key Inclusion Criteria:\n\n* Adults ≥ 18 years of age who are willing and able to provide written informed consent\n* Have an ECOG performance status of ≤ 1. Subjects with an ECOG performance status of 2 may be enrolled with Medical Monitor approval.\n* Pathologically confirmed diagnosis of DLBCL, as defined by the 2016 World Health Organization classification including DLBCL NOS high-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements, Epstein-barr virus (EBV) positive DLBCL, and T cell rich B cell lymphoma (TCRBCL). Subjects with DLBCL transformed from indolent lymphoma (except for Richter's transformation) are eligible.\n* Subjects must have progressive disease following at least two (2) lines of prior systemic therapy for DLBCL; prior treatment must have included an anthracycline and rituximab (or another CD20-targeted agent).\n* Subjects must have failed or be ineligible for ASCT or CAR-T\n* Have at least one bi-dimensionally measurable lesion per Lugano (2014)\n* Willing to provide pre-treatment and on-treatment tumor biopsy tissue.\n* Meet protocol-specified laboratory requirements\n* Life expectancy \\> 3 months.\n\nKey Exclusion Criteria:\n\n* Primary CNS lymphoma or active secondary CNS involvement and\u002For lymphomatous meningitis\n* Chemotherapy, immunotherapy, major surgery, or investigational agent treatment within 28 days of D0 or 5 half-lives, whichever is shorter\n* Radiotherapy within 14 days of day 0\n* Autologous stem cell transplant (ASCT) within ˂100 days prior to D0\n* Chimeric antigen receptor T cell (CAR-T) therapy within ˂28 days prior to D0\n* Diagnosis of immunodeficiency disorder or history of active autoimmune disease that has required systemic treatment in the past 2 years\n* Uncontrolled significant active infections (controlled Hepatitis B, Hepatitis C, or HIV may be eligible)\n* Prior history of malignancy other than eligible lymphoma sub-types, unless the subject has been free of the disease for ≥ 2 years prior to the start of study treatment",{"count":124,"type":20},102,[23],"This is a Phase 2b, randomized, open label study to assess the safety and efficacy of DPX-Survivac and pembrolizumab, with and without low-dose cyclophosphamide (CPA) in subjects with relapsed or refractory DLBCL.",[128,85],"Relapsed Diffuse Large B-cell Lymphoma",[56,130,131,132,133,134],"T cell activation","DLBCL","Anti-PD-1","CAR-T ineligible","ASCT ineligible","2023-04-05",{"date":137,"type":64},"2023-04-07",{"date":139,"type":64},"2021-06-18",{"date":141,"type":20},"2025-04",{"name":143,"class":71},"ImmunoVaccine Technologies, Inc. (IMV Inc.)",50]