[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"non-hodgkin-lymphoma-refractory-relapsed\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:non-hodgkin-lymphoma-refractory-relapsed":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,56,91,118,148],{"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":34,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":4},"100652151","phase-2-baff-car-t-cells-lmy-920-for-treatment-of-relapsed-or-refractory-non-hodgkin-lymphoma-and-multiple-myeloma-100652151",false,"NCT07771361","BAFF CAR-T Cells (LMY-920) for Treatment of Relapsed or Refractory Non-Hodgkin Lymphoma and Multiple Myeloma","Phase 2 Study of BAFF CAR-T Cells (LMY-920) for Treatment of Relapsed\u002FRefractory Non-Hodgkin Lymphoma (NHL) and Multiple Myeloma (MM)","Inclusion Criteria:\n\n1. Histologically confirmed:\n\n   a. B cell NHL (Including but not limited to diffuse large B cell lymphoma, follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, chronic lymphocytic leukemia and small lymphocytic lymphoma) i. Relapsed after 2 or more lines of therapy, or ii. Have disease refractory to prior chemotherapy (defined as progressive disease or stable disease lasting ≤ 6 months, as best response to most recent chemotherapy regimen; or disease progression, or recurrence ≤ 12 months after prior autologous stem cell transplantation (ASCT).\n\n   iii. At least one measurable lesion according to Lugano Revised Response Criteria for Malignant Lymphoma.\n\n   OR b. MM i. Relapsed or refractory after 3 or more lines of therapy including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.\n\n   ii. Measurable disease per IMWG uniform response criteria\n2. No evidence of CNS lymphoma.\n3. Participant is ≥ 18 years of age.\n4. ECOG Performance status ≤ 2.\n5. \\> 2 weeks since prior radiation therapy or systemic therapy at the time of leukapheresis. Patients with mantle cell lymphoma that can only remain stable with continuation of prior BTK inhibitor may continue these agents up to 48 hours prior to apheresis.\n6. Adequate organ function as defined by:\n\n   1. Total bilirubin ≤ 1.5× institutional upper limit of normal (except in patients with Gilbert's syndrome, active hemolysis or disease involvement of the liver.)\n   2. AST (SGOT)\u002FALT ≤ 2.5 × institutional upper limit of normal.\n   3. Calculated creatinine clearance ≥ 30ml\u002Fmin.\n   4. Cardiac ejection fraction of ≥ 50%\n   5. Adequate pulmonary function as defined as pulse oximetry ≥ 92% on room air.\n7. Subjects (or legal guardians) must have the ability to understand and the willingness to sign a written informed consent document.\n8. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \\\u003C 1% per year during the treatment period and for at least 6 months after the BAFF CAR-T cell infusion.\n9. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures with a failure rate of \\\u003C 1% per year during the treatment period , and agreement to refrain from donating spermfor at least 6 months after the BAFF CAR-T cell infusion.\n\nExclusion Criteria:\n\n1. ASCT within 6 weeks prior to informed consent.\n2. History of allogeneic transplantation.\n3. Active graft-versus-host disease.\n4. Active central nervous system or meningeal involvement by lymphoma or leukemia. Subjects with untreated brain metastases\u002FCNS disease will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Patients with a history of CNS or meningeal involvement must be in a documented remission by CSF evaluation and contrast-enhanced MRI imaging for at least 90 days prior to enrollment.\n5. Known active additional malignancies which require systemic treatment (non-immediately morbid malignancies receiving only low-toxicity regimens such as hormone suppression for prostate or breast cancer may be allowed at the judgment of the investigator.)\n6. Less than 28 days elapsed between prior treatment with investigational agent(s) and the day of lymphocyte collection.\n7. Cardiovascular disorders including symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmias, myocardial infarction or stroke (including transient ischemic attack, or other ischemic event).\n8. Active infection requiring intravenous systemic treatment.\n9. HIV seropositivity.\n10. Pregnant or breastfeeding women are excluded from this study.\n11. Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy.\n12. Serologic status reflecting active hepatitis B or C infection. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive patients will be excluded.)\n13. Patients with history of active and clinically relevant CNS pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease.\n14. Subjects with uncontrolled intercurrent illness or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n15. History of autoimmune disease (i.e., rheumatoid arthritis, systemic lupus erythematosus) with requirement of immunosuppressive medications (other than low dose steroids) within 2 months.","ALL","18 Years",{"count":19,"type":20},90,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Therapy with chimeric antigen receptor T (CAR-T) cells has demonstrated activity against relapsed or refractory B cell non-Hodgkin lymphoma and multiple myeloma, however not all tumors respond or remain in response to CD19 targeted CAR-T cells. We posit that CAR-T cells expressing BAFF (BAFF CAR-T cells) can become another strategy to treat refractory lymphoma, even after relapse following cluster of differentiation antigen 19 (CD19) targeting CAR-T treatment.\n\nThis Phase 2 study will establish the safety and efficacy profile of LMY-920.",[26,27,28,29,30,31,32,33],"Non-Hodgkin Lymphoma Refractory\u002F Relapsed","Multiple Myeloma Refractory","Multiple Myeloma in Relapse","Non-Hodgkin Lymphoma, B-cell","Non-Hodgkin Lymphoma","Non-Hodgkin Lymphoma (NHL)","Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma","Multiple Myeloma in Remission",[35,30,36,37,38,39,40,41,42,43],"Multiple Myeloma","Refractory","Relapsed","CAR-T","B-cell","Lymphoma","Neoplasms","Lymphoma, B-Cell","Lymphoma, Non-Hodgkin","NOT_YET_RECRUITING","2026-08-14",{"date":47,"type":48},"2026-08-18","ACTUAL",{"date":50,"type":20},"2026-12",{"date":52,"type":20},"2031-02",{"name":54,"class":55},"Luminary Therapeutics","INDUSTRY",{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":21,"phases":66,"briefSummary":68,"conditions":69,"keywords":76,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":90},"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":65,"type":20},400,[67],"PHASE3","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.",[70,42,71,72,30,26,73,74,75],"Large B-cell Lymphoma","Relapsed Non-Hodgkin Lymphoma","Refractory Non-Hodgkin Lymphoma","Diffuse Large B Cell Lymphoma (DLBCL)","Diffuse Large B Cell Lymphoma Refractory","Diffuse Large B Cell Lymphoma Relapsed",[40,30,77,78,79,70],"CAR T-Cell Therapy","CD19","CD19\u002FCD20","RECRUITING","2026-07-31",{"date":83,"type":48},"2026-08-04",{"date":85,"type":48},"2026-01-12",{"date":87,"type":20},"2032-01",{"name":89,"class":55},"Lyell Immunopharma, Inc.",36,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":21,"phases":100,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":117},"100602318","phase-1-this-is-a-phase-1-study-to-evaluate-the-safety-of-ltz-301-in-patients-with-non-hodgkin-lymphoma-100602318","NCT07121946","This is a Phase 1 Study to Evaluate the Safety of LTZ-301 in Patients With Non-Hodgkin Lymphoma","A Phase 1, Open-label, Multicenter Study of LTZ-301 in Subjects With Relapsed\u002FRefractory Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Relapsed or refractory to at least 2 prior systemic treatment regimens\n* At least 1 bi-dimensionally measurable lesion (≥ 1.5 cm) in longest dimension\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* Adequate bone marrow, cardiac, pulmonary, renal, and hepatic function\n\nExclusion Criteria:\n\n* CLL, or Richters transformation\n* Prior solid organ transplant\n* Prior allogeneic stem cell transplant\n* ASCT within 100 days prior to the first LTZ-301 administration\n* Prior CAR-T within 60 days prior to the first LTZ-301 administration\n* Current central nervous system (CNS) lymphoma\n* Known history of human immunodeficiency virus (HIV) seropositivity\n* Active autoimmune disease\n* History of clinically significant cardiovascular disease\n* symptomatic deep vein thrombosis (DVT) within 3 months of enrollment\n* History of other malignancy within 3 years prior to screening",{"count":99,"type":20},42,[101],"PHASE1","This study is a first-in-human (FIH), Phase 1, multicenter, open-label study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and evaluate the preliminary anti-tumor activity of LTZ-301 administered as a single agent in adult subjects with relapsed or refractory B-cell non-Hodgkin lymphoma",[26,104,105,106,107],"DLBCL - Diffuse Large B Cell Lymphoma","Mantle Cell Lymphoma (MCL)","Follicular Lymphoma ( FL)","Marginal Zone Lymphoma (MZL)","2026-07-22",{"date":110,"type":48},"2026-07-24",{"date":112,"type":48},"2026-01-29",{"date":114,"type":20},"2028-02",{"name":116,"class":55},"LTZ Therapeutics, Inc.",6,{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":125,"enrollmentInfo":126,"targetDuration":4,"studyType":21,"phases":128,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":147},"100614763","phase-2-amping-up-with-pemjak-100614763","NCT07283822","Amping up With PemJAK","A Phase II Trial of JAK Inhibitor Added to Immunotherapy for Treatment of Relapsed\u002FRefractory T-cell Lymphoma and 9p Amplified Lymphomas","Inclusion Criteria:\n\n* (1) Histologically confirmed relapsed\u002Frefractory HL, PMBCL, GZL, and TCL including the below subtypes:\n\n  * Arm 1: PTCL\n\n    * Nodal PTCL Peripheral T-cell Lymphoma- Not Otherwise Specified (PTCL-NOS)\n    * Anaplastic Large Cell Lymphoma (ALCL) T-follicular Helper Lymphomas (TFH) and its subtypes including angioimmunoblastic T-cell Lymphoma (AITL)\n    * Extranodal NK\u002FT-cell lymphoma\n    * Subcutaneous Panniculitis T-Cell Lymphoma\n  * Arm 2: CTCL\n\n    * Mycosis Fungoides\n    * Sezary Syndrome\n  * Arm 3: exploratory cohort\n\n    * Classic HL\n    * PMBCL\n    * GZL\n* (2) All patients must have received at least one-line systemic therapy.\n\n  * Patients with systemic ALCL must have received prior CD30-directed therapy.\n  * Other PTCL subtypes that express CD30 (\\>10%), must have received prior CD30-directed therapy.\n  * Special Consideration for CTCL in Arm 2:\n\n    * Systemic therapies including bexarotene (targretin) are permissible up to 2 weeks prior to enrollment.\n    * Skin directed therapies including light therapy\u002Fphototherapy, extracorporeal photopheresis (ECP), topical steroids, or mechlorethamine (valchlor) gel are NOT considered a systemic line of therapy when given alone.\n    * Treatment with radiation, phototherapy, histone deacetylase inhibitor, retinoids, interferons, therapeutic doses of systemic corticosteroids, or denileukin diftitox (18 µg\u002Fkg\u002Fday) up to 2 weeks prior to enrollment is allowed.\n    * Treatment with alemutuzumab up to 8 weeks prior to enrollment is permissible.\n* (3) Patients must not have had chemotherapy or immunotherapy within 2 weeks prior to entering the study and must have recovered from adverse events (to grade 1 or less)\n* (4) Anti PD-1\u002FPDL-1is permissible up to two weeks prior to enrollment.\n* (5) Age ≥ 18\n* (6) Participants must have measurable disease, as defined in the protocol\n\n  * Patients must have a PET-CT scan performed within ≤4 weeks.\n  * Contrast enhanced CT scan or MRI of the neck, chest, abdomen, pelvis is permissible, however; PET is preferred.\n* (7) Patients cannot have active central nervous system (CNS) disease. Patients that have been treated and asymptomatic are allowed on study.\n* (8) All participants must be screened for chronic hepatitis B virus (HBV) with hepatitis B viral load and serologies (core antibody, surface antigen, and surface antibody) within 30 days prior to enrollment.\n\n  * Patients with positive Hep B core will need to be on HBV prophylaxis\n  * Patients with positive Hep B core will need to be on HBV prophylaxis.\n* (9) Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. If actively on treatment, HCV viral load mut be undetectable 30 days prior to enrollment.\n* (10) Participants with known human immunodeficiency virus (HIV)-infection are eligible providing they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test (must be within 26 weeks prior to enrollment).\n* (11) Organ function as assessed by laboratory testing and Eastern Cooperate Oncology Group (ECOG) performance status 0-2 and or a Karnofsky performance score of equal or greater to 50 (see Section 20.1.1, Appendix A) for receipt of ruxolitinib and pembrolizumab.\n\n  * Absolute Neutrophil Count ≥ 1000\u002FμL (not growth factor independent)\n  * Platelets ≥ 70,000\u002FμL (or ≥50,000\u002Fmm3 if known bone marrow involvement with dose modifications allowed. See protocol for specific instructions for dose modifications).\n  * Baseline hemoglobin level ≥ 8 g\u002FdL (irrespective of bone marrow involvement).\n  * Calculated creatinine clearance ≥ 30 ml\u002Fmin using the Cockcroft-Gault formula\n  * Bilirubin ≤ 2 x upper limit of normal (ULN)\n  * Aspartate aminotransferase (AST) ≤ 2.5 × ULN\n  * Alanine aminotransferase (ALT) ≤ 2.5 × ULN\n* (12) Ability to understand and the willingness to sign a written informed consent document.\n* (13) Patients with prior history of deep vein thrombosis (DVT) that has been treated or actively requiring anticoagulation are permitted to enroll.\n* (14) Due to the potential teratogenic effects, women of childbearing age must have a documented negative serum β-hCG measured within 2 weeks of starting treatment. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician and Incyte immediately (see protocol). Additionally, both women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence).\n\nContraception should continue for 6 months after you stop taking study drug. Similarly, women must agree to not breastfeed during the entirety of the study period.\n\nExclusion Criteria:\n\n* 1\\) Diagnosis of Adult T-Cell Leukemia\u002FLymphoma (ATLL)\n* 2\\) History of autoimmune disease that requires systemic treatment.\n* 3\\) Has a diagnosis of immunodeficiency or receiving immunosuppressive therapy within 7 days prior to the first dose of study drug.\n* 4\\) Actively chronic systemic steroids therapy (in dosing exceeding 10mg daily of prednisone or its drug equivalent).\n\n  o Patients must be off steroid therapy exceeding 10mg or greater of prednisone (or its equivalent) at the start of therapy.\n* 5\\) Patients with HL and PMBCL patients must not be eligible and agreeable to autologous stem cell transplant.\n\n  o Patients with PMBCL must not be eligible and agreeable to CAR-T.\n* 6\\) Allowed to have disease progression after or refractory to autologous bone marrow transplant.\n* 7\\) Progression after allogeneic stem cell transplantation (SCT) can be determined on a case-by-case basis after discussion with the primary investigator.\n* 8\\) History of solid organ transplant requiring active immunosuppression for which treatment with immunotherapy would be contraindicated.\n* 9\\) Active TB (Tuberculosis Bacillus) at time screening. Prior cases of adequately treated TB are permissible.\n* 10\\) Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients.\n* 11\\) Has severe hypersensitivity (≥ Grade 3) to ruxolitinib and\u002For any of its excipients.\n\nPatients with G1 and G2 hypersensitivity remain eligible.\n\n* 12\\) Inability to swallow or take medications by mouth\n* 13\\) Is pregnant or breastfeeding or expected to conceive children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n* 14\\) History of concurrent and active malignancy for which he or she is currently receiving directed therapy for.\n* 15\\) History of major adverse cardiac events such as myocardial infraction or stroke within 6 months of enrollment. Cardiovascular events within 6 months such as pulmonary embolism and deep vein thrombosis is permissible if on therapeutic treatment.\n* 16\\) Subjects with active, systemic, and uncontrolled bacterial, viral, or fungal infections at the time of screening will be excluded from study participation.\n\nExceptions include:\n\nInfections that have been appropriately treated, with evidence of clinical resolution and return to baseline organ function within 14 days prior to study entry.\n\n* Localized, non-systemic infections (e.g., uncomplicated urinary tract infections or cellulitis) that are being actively managed and are not associated with systemic symptoms.\n* Please see section protocol for eligibility requirements specifically for HCV, HBV, HIV and Tuberculosis infections at time of screening.","95 Years",{"count":127,"type":20},53,[23],"The purpose of this study is to understand and determine if ruxolitinib added to pembrolizumab is safe and effective for the treatment of relapsed or refractory Hodgkin and non-Hodgkin lymphomas.",[30,131,26,132,133,134,135,136],"Hodgkin Disease Lymphoma","Hodgkin Disease Recurrent","Gray Zone Lymphoma","Peripheral T-cell Lymphoma","Cutaneous T-Cell Lymphomas","Primary Mediastinal B Cell Lymphoma","2025-12-06",{"date":139,"type":48},"2025-12-16",{"date":141,"type":48},"2025-12-03",{"date":143,"type":20},"2029-01",{"name":145,"class":146},"Seda S. Tolu","OTHER",1,{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":155,"enrollmentInfo":156,"targetDuration":4,"studyType":21,"phases":158,"briefSummary":159,"conditions":160,"keywords":161,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":147},"100613786","phase-2-study-of-cart-cell-mb-cart191-in-patients-with-relapsed-or-refractory-cd19-positive-nhl-100613786","NCT07271121","Study of CART Cell (MB-CART19.1) in Patients With Relapsed or Refractory CD19 Positive NHL","A Phase II Study of CART Cell (MB-CART19.1) in Patients With Relapsed or Refractory CD19 Positive NHL","Inclusion Criteria:\n\n1. Eligible patients with a diagnosis of aggressive NHL:\n\n   1. Patients after progression on at least one standard chemotherapy and one salvage regimen or\n   2. Patients considered for alloSCT but are found ineligible or\n   3. Patients who have relapsed post alloSCT at least 100 days post-transplant, with no evidence of active GVHD, and no longer taking immunosuppressive agents for at least 30 days prior to enrollment.\n2. Patients with CNS disease (excluding isolated CNS lymphoma) are eligible only if disease has been successfully cleared at the time of inclusion.\n3. CD19 expression must be detected on the malignant cells by flow cytometry or immunohistochemistry\n4. Age \\> 18 year up to 75 years old (if deemed fit by treating investigator);\n5. Baseline absolute CD3+ T cell count by FACS ≥100\u002Fµl;\n6. ECOG performance score of 0-2 at screening;\n7. No active Hepatitis B, Hepatitis C, HIV I\u002FII\n8. No childbearing potential or negative pregnancy test at screening within 7 days from starting lymphodepletion chemotherapy and before bridging chemotherapy in women with childbearing potential;\n9. Signed and dated informed consent, before conduct of any trial-specific procedure.\n\nExclusion Criteria:\n\n1. Residual CNS disease\n2. Current autoimmune disease, or history of autoimmune disease with potential CNS involvement;\n3. Active clinically significant CNS dysfunction (including but not limited to uncontrolled seizure disorders, cerebrovascular ischemia or hemorrhage, dementia, paralysis)\n4. History of an additional malignancy other than non-melanoma skin cancer or carcinoma in situ unless disease free for ≥3 years;\n5. Pulmonary function: Patients with pre-existing severe lung disease or DLCO of less than 50% or active pulmonary infiltrates on imaging studies.\n6. Cardiac function: left ventricular ejection faction \\\u003C50% by echocardiogram,\n7. Renal function: Creatinine clearance \\\u003C50 mL\u002Fmin\u002F1.73 m2, by Cockcroft-Gault formula (Cockcroft and Gault 1976) for patients ≥18 years.\n8. Liver function: patients with serum bilirubin ≥3 times upper limit of or AST or ALT \\> 5 times upper limit of normal, unless due to lymphoma liver infiltration in the estimation of the investigator.\n9. Rapidly progressive disease that in the estimation of the investigator would compromise ability to complete study therapy;\n10. Pregnant or breast-feeding females\n11. Medications: systemic chemotherapies, corticosteroids with the exception of physiologic replacement dosing, Fludarabine\u002Fclofarabine or immunosuppressive (Calcineurin inhibitors) drugs and antibodies or investigational drugs or donor lymphocyte transfusions or radiation therapy within 30 days prior to apheresis, and rituximab within 2 weeks with the exception of Intrathecal chemotherapy is allowed prior to treatment, but should be discontinued 10 days prior to-CART19 infusion to limit the risk of neurotoxicities;\n12. Patients of child-bearing or fathering potential not willing to practice an effective form of birth control from the time of enrollment and for three months after dosing of the CARTs;\n13. Concurrent participation in another interventional trial that could interact with this trial, e.g. CAR T trials.\n14. Other investigational treatment within 4 weeks before CARTs infusion;\n15. Cerebral dysfunction, legal incapacity of adult patients;\n16. Committal to an institution on judicial or official order.","75 Years",{"count":157,"type":20},26,[23],"This is a Prospective Single Center, open label, Non-randomized, Single Arm, Single Dose, Phase II Clinical Trial. Adult patients \\>18-year-old with CD19+ Non-Hodgkin lymphoma are eligible for the study if they meet eligibility criteria. Patients will receive a fresh single dose of MB-CART-19.1 and will be followed for 12 months and evaluated for efficacy and safety.",[26],[26,162],"MB-CART-19.1",{"date":164,"type":48},"2025-12-09",{"date":166,"type":48},"2025-02-12",{"date":168,"type":20},"2028-06-30",{"name":170,"class":146},"King Hussein Cancer Center"]