[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"mantle-cell-lymphoma-mcl\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:mantle-cell-lymphoma-mcl":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,26,0,25,[9,48,104,142,172,201,227,254,286,319,343,354,383,411,439,462,482,503,522,546,565,579,600,622,648],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100053791","registry-platform-hematologic-malignancies-rubin---extension-of-tumor-registry-lymphatic-neoplasms-100053791",false,"NCT06043011","Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms","Clinical Research Platform on Treatment, Quality of Life and Outcome of Patients With Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms","RUBIN","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Confirmed diagnosis of the respective NHL\n* If patient is alive: signed written informed consent\n\n  * For patients participating in the PRO survey: IC prior to or at day of start of respective line of treatment.\n  * For patients not participating in the PRO survey: IC latest eight weeks after start of respective line of treatment.\n\nExclusion Criteria:\n\n* No systemic therapy for respective lymphoid malignancy.","ALL","18 Years",{"count":21,"type":22},2950,"ESTIMATED","5 Years","OBSERVATIONAL","The purpose of the project is to set up a national, prospective, longitudinal, multicenter registry platform to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with hematological malignancies in Germany.",[27,28,29,30,31,32],"Chronic Lymphocytic Leukemia (CLL)","Diffuse Large B-cell Lymphoma (DLBCL)","Follicular Lymphoma (FL)","Mantle Cell Lymphoma (MCL)","Marginal Zone Lymphoma (MZL)","Waldenström's Macroglobulinemia (WM)",[34],"non-Hodgkin lymphoma (NHL)","RECRUITING","2026-07-10",{"date":38,"type":39},"2026-07-13","ACTUAL",{"date":41,"type":39},"2023-09-27",{"date":43,"type":22},"2033-12",{"name":45,"class":46},"iOMEDICO AG","INDUSTRY",1,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":70,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},"100054189","phase-2-daly-ii-usa-mb-cart20191-for-dlbcl-100054189","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",{"count":56,"type":22},315,"INTERVENTIONAL",[59],"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.",[62,63,64,65,66,67,30,68,69],"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","Richter Transformation","Transplant-ineligible 2nd Line DLBCL",[71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94],"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","2026-07-09",{"date":38,"type":39},{"date":98,"type":39},"2021-05-25",{"date":100,"type":22},"2028-12-31",{"name":102,"class":46},"Miltenyi Biomedicine GmbH",32,{"id":105,"slug":106,"hasResults":12,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":57,"phases":113,"briefSummary":115,"conditions":116,"keywords":122,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":141},"100449326","phase-1-a-study-of-nx-5948-in-adults-with-relapsedrefractory-b-cell-malignancies-100449326","NCT05131022","A Study of NX-5948 in Adults With Relapsed\u002FRefractory B-cell Malignancies","A Phase 1, Dose Escalation, and Cohort Expansion Study Evaluating NX-5948, a Bruton's Tyrosine Kinase (BTK) Degrader, in Adults With Relapsed\u002FRefractory B-cell Malignancies","Key Inclusion Criteria:\n\n* Age ≥18 years\n* Patients in Phase 1a (Dose Escalation) must have histologically confirmed R\u002FR CLL, SLL, DLBCL (subgroups include Richter-transformed DLBCL, germinal center B-cell type, activated B-cell type, high-grade B-cell lymphoma with MYC and BCL-2 and\u002For BCL-6 rearrangements, high-grade B-cell lymphomas NOS), FL, MCL, MZL (subtypes include EMZL, MALT, NMZL, SMZL), WM, or PCNSL.\n* Patients in Phase 1a must meet the following:\n\n  o For non-PCNSL indications, received at least 2 prior lines of therapy and have no other available therapies known to provide clinical benefit. For PCNSL, received at least 1 prior line of therapy\n* Patients in Phase 1b (Safety and Cohort Expansion) must have 1 of the following histologically documented B-cell malignancies, must meet criteria for systemic treatment, and must have received prior therapies and\u002For molecular features based on details described for each cohort: CLL or SLL, DLBCL, MCL, FL, MZL, WM, or PCNSL\u002FSCNSL.\n* Measurable disease per response criteria specific to the malignancy.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (0-2 for patients with PCNSL and secondary CNS involvement).\n* Adequate organ and bone marrow function\n\nKey Exclusion Criteria:\n\n* Known or suspected active prolymphocytic leukemia or Richter's transformation to Hodgkin's lymphoma prior to study enrollment\n* Prior treatment for the indication under study for anti-cancer intent that includes:\n\n  1. Radiotherapy within 2 weeks of planned start of study drug (excluding limited palliative radiation).\n  2. Prior systemic chemotherapy within 2 weeks of planned start of study drug.\n  3. Prior monoclonal antibody therapy within 4 weeks of planned start of study drug, except for patients enrolling in Cohort 16 (CLL with secondary wAIHA) where a 16-week washout period is required.\n  4. Prior small molecule therapy within 2 weeks or 5 half-lives (whichever is shorter) of planned start of study drug.\n  5. Autologous or allogeneic stem cell transplant within 100 days prior to planned start of study drug.\n  6. Chimeric antigen receptor (CAR) T-cell therapy within 100 days prior to start of study drug (within 60 days prior to start of study drug for Phase 1b).\n  7. Use of systemic corticosteroids outside of dosing limits described below and within 7 days prior to initiation of study treatment excepting those used as prophylaxis for radio diagnostic contrast. Patients with PCNSL\u002FSCNSL: no greater than 40 mg\u002Fday prednisone, or equivalent. Patients with PCNSL\u002FSCNSL using greater than 20 mg\u002Fday prednisone, or equivalent, must be clinically stable at that dose for 7 days. All other diagnoses: no greater than 20 mg\u002Fday prednisone or equivalent.\n  8. Use of systemic immunosuppressive drugs other than systemic corticosteroids for any medical condition within 60 days prior to first dose of study drug\n  9. Previously treated with a BTK degrader\n* Active, uncontrolled autoimmune hemolytic anemia (except for patients enrolling in Cohort 16) or active, uncontrolled autoimmune thrombocytopenia.\n* Patient has any of the following within 6 months of planned start of study drug:\n\n  1. Myocardial infarction, unstable angina, unstable symptomatic ischemic heart disease, or placement of a coronary arterial stent\n  2. Uncontrolled atrial fibrillation or other clinically significant arrhythmias, conduction abnormalities, or New York Heart Association (NYHA) class III or IV heart failure\n  3. Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), stroke, or intracranial hemorrhage\n  4. Any other significant cardiac condition (e.g., pericardial effusion, restrictive cardiomyopathy, severe untreated valvular stenosis, severe congenital heart disease, or persistent uncontrolled hypertension defined as systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg despite optimal medical management)\n* Bleeding diathesis, or other known risk for acute blood loss.\n* History of Grade ≥ 2 hemorrhage within 28 days of planned start of study drug.\n* Active known concurrent malignancy or malignancy other than the one under study within the past 3 years. (Exceptions include, but are not limited to, patients with more recent history of basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast may enroll if they have undergone curative therapy and have no evidence of disease).",{"count":112,"type":22},572,[114],"PHASE1","This is a first-in-human Phase 1a\u002F1b multicenter, open-label study designed to evaluate the safety and anti-cancer activity of NX-5948 in patients with advanced B-cell malignancies.",[27,117,118,29,30,31,119,120,121],"Small Lymphocytic Lymphoma (SLL)","Diffuse Large B Cell Lymphoma (DLBCL)","Waldenstrom Macroglobulinemia (WM)","Primary Central Nervous System Lymphoma (PCNSL)","Secondary Central Nervous System Lymphoma (SCNSL)",[123,124,125,84,126,127,128,129,130,131],"BTK Degrader","BTK Inhibitor","B-Cell Malignancy","C481","C481S","Bruton's Tyrosine Kinase","NX-5948","Targeted Protein Degradation","Chimeric Targeting Molecule (CTM)","2026-06-30",{"date":134,"type":39},"2026-07-02",{"date":136,"type":39},"2022-04-13",{"date":138,"type":22},"2028-01",{"name":140,"class":46},"Nurix Therapeutics, Inc.",62,{"id":143,"slug":144,"hasResults":12,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":57,"phases":151,"briefSummary":152,"conditions":153,"keywords":158,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":171},"100591414","phase-1-dose-determining-study-of-exs73565-in-participants-with-relapsed-or-refractory-b-cell-malignancies-100591414","NCT06980116","Dose Determining Study of EXS73565 in Participants With Relapsed or Refractory B-Cell Malignancies","A Phase 1 Open-label, Multicenter, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of EXS73565 in Participants With Relapsed or Refractory B-cell Malignancies","Key Inclusion Criteria:\n\n* Age ≥18 years at the time of signing the informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Histologically confirmed diagnosis of one of the following B-cell malignancies: chronic lymphocytic leukemia (CLL), including Richter's transformation from CLL, mantle-cell lymphoma, diffuse large B-cell lymphoma, follicular lymphoma, marginal zone lymphoma, or waldenström macroglobulinaemia.\n* Participants that have relapsed after standard of care or have progressed during standard of care or are not suitable for standard of care therapy\n\nKey Exclusion Criteria:\n\n* Any medical or psychiatric condition that, in the view of the Principal Investigator, could jeopardize or would compromise the participant's safety or ability to participate in the study.\n* Known central nervous system (CNS) malignancy or primary CNS lymphoma.\n* Concurrent active or previous malignancy (other than the primary lymphoma\u002FCLL for which the participant will be treated on this protocol within 5 years prior to randomization; participants with prior cancers may be enrolled with documented Sponsor approval.\n* Received anticancer therapy, including chemotherapy, immunotherapy, radiation therapy (with the exception of palliative radiotherapy), biologic therapy, cancer-related hormonal therapy, or any investigational therapy within 14 days or 5 half-lives (whichever is shorter) before the first dose of the study treatment.",{"count":150,"type":22},85,[114],"The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of EXS73565 administered orally as a single agent in participants with relapsed\u002Frefractory B-cell malignancies.",[154,155,29,31,30,156,157],"Relapsed or Refractory B-cell Malignancies","Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL)","Diffuse-large B-cell Lymphoma (DLBCL)","Waldenstrom's Macroglobulinemia (WM)",[159,160,29,31,30,156,157,161],"B-cell Malignancies","Chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma (CLL\u002FSLL)","MALT1","2026-06-09",{"date":164,"type":39},"2026-06-11",{"date":166,"type":39},"2025-03-31",{"date":168,"type":22},"2028-12",{"name":170,"class":46},"Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.",9,{"id":173,"slug":174,"hasResults":12,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":57,"phases":181,"briefSummary":182,"conditions":183,"keywords":187,"overallStatus":191,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":4},"100642551","phase-1-a-study-of-rocbrutinib-in-combination-with-lacutoclax-in-patients-with-b-cell-malignancies-100642551","NCT07609862","A Study of Rocbrutinib in Combination With Lacutoclax in Patients With B-Cell Malignancies","A Phase Ib\u002FII, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BTK Inhibitor Rocbrutinib in Combination With BCL-2 Inhibitor Lacutoclax in Patients With B-Cell Malignancies","Inclusion Criteria:\n\n1. Age ≥18 years, regardless of sex.\n2. Ib: Histologically confirmed diagnosis of CLL\u002FSLL (per 2018 iwCLL criteria) or B-cell malignancies (per 2022 WHO classification), including: MCL, DLBCL, FL, and WM. Must have received at least one prior line of systemic therapy, with documented disease progression or intolerance.\n\n   II: For Treatment-naïve (TN) CLL\u002FSLL patients: Must meet iwCLL treatment indications and no prior systemic therapy. For R\u002FR CLL\u002FSLL patients: at least one prior systemic therapy with documented disease progression or intolerance.\n3. Have at least one measurable lesion.\n4. Phase Ib: ECOG performance status ≤1; phase II: ECOG performance status ≤2.\n5. Life expectancy ≥ 12 weeks.\n6. Adequate coagulation function, liver and kidney function, bone marrow hematopoietic function.\n7. Male patients and female patients of childbearing potential must agree to use effective contraception during the study and for 90 days after the last dose of study treatment. Female patients of childbearing potential must have a negative pregnancy test before study treatment and must not be breastfeeding. Male patients must not donate sperm during the study and for 90 days after the last dose.\n8. Participation is voluntary, requiring signed informed consent and compliance with the treatment regimen and visit schedule.\n\nExclusion Criteria:\n\n1. Known hypersensitivity or intolerance to Rocbrutinib, Lacutoclax, or any of their excipients; prior treatment with any BCL-2 inhibitor; or prior treatment with both covalent and non-covalent BTK inhibitors.\n2. Use of systemic corticosteroids at doses equivalent to \\>20 mg\u002Fday of prednisone for ≥3 days within 7 days prior to the first dose.\n3. History of or currently suspected Richter's syndrome.\n4. Known or suspected central nervous system (CNS) involvement.\n5. Prior allogeneic hematopoietic stem cell transplantation (allo-HSCT), or autologous hematopoietic stem cell transplantation (auto-HSCT) or chimeric antigen receptor T-cell (CAR-T) therapy within 90 days before the first dose of study treatment.\n6. Received antitumor therapy, investigational agents, major surgery, severe trauma, or live attenuated vaccines within 4 weeks or 5 half-lives prior to the first dose of study treatment.\n7. Received herbal medicines for antitumor treatment, or localized radiotherapy within 14 days prior to the first dose of study treatment.\n8. Use of moderate or strong CYP3A inhibitors within 7 days prior to the first dose of study treatment, or consumption of grapefruit, grapefruit juice, starfruit, or Seville oranges within 3 days prior to prior to the first dose.\n9. History of other active malignancies within the past 3 years, except for curatively treated basal cell carcinoma, localized squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or other malignancies considered cured.\n10. Any severe and\u002For uncontrolled systemic disease, or any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in the study.\n11. Any of the following events within 6 months prior to the first dose: Symptomatic arrhythmia, myocardial infarction, intracranial hemorrhage, or Stroke.\n12. Impaired cardiac function.\n13. Any uncontrolled systemic infection.\n14. Conditions that may impair oral drug administration or significantly affect absorption or pharmacokinetics of the study drug.\n15. Unable to discontinue moderate or strong CYP3A inhibitors or inducers, P-gp (P-glycoprotein) inhibitors, sensitive substrates of OATP1B3 or CYP2C8 during the study period.\n16. Received vaccination with any live-attenuated vaccines within 4 weeks prior to the first dose of study treatment.\n17. Evidence of an active bleeding constitution or a history of significant hemorrhagic disorders.\n18. Requirement for ongoing therapy with warfarin or other vitamin K antagonists.\n19. Presence of an active, uncontrolled, or symptomatic autoimmune disease that requires systemic treatment.\n20. Any other condition that, in the investigator's judgment, makes the patient unsuitable for study participation.",{"count":180,"type":22},92,[114,59],"BTK inhibitors and BCL-2 inhibitors have demonstrated significant clinical activity in mature B-cell malignancies, and combination therapy may provide improved clinical benefit. This is a multi-center, open-label, single-arm Phase Ib\u002FII clinical study. The purpose of this clinical trial is to investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of Rocbrutinib, a fourth-generation Bruton tyrosine kinase inhibitor (BTKi), in combination with the BCL-2 inhibitor Lacutoclax in patients with mature B-cell malignancies. The Phase Ib will use a classic 3+3 dose-escalation design to evaluate dose-limiting toxicities (DLTs), determine the maximum tolerated dose (MTD), and identify the recommended dosing regimen. The Phase II portion is intended to further evaluate the efficacy and safety of the combination therapy.",[30,184,185,186,155],"Diffuse Large B-Cell Lymphoma (DLBCL)","Follicular Lymphoma ( FL)","Waldenström Macroglobulinemia (WM)",[188,189,190],"mature B-cell malignancies","BTK inhibitor","BCL-2 inhibitor","NOT_YET_RECRUITING","2026-06-07",{"date":194,"type":39},"2026-06-10",{"date":196,"type":22},"2026-05-30",{"date":198,"type":22},"2033-05-30",{"name":200,"class":46},"Guangzhou Lupeng Pharmaceutical Company LTD.",{"id":202,"slug":203,"hasResults":12,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":57,"phases":211,"briefSummary":212,"conditions":213,"keywords":214,"overallStatus":191,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":4},"100636767","phase-2-frontline-risk-adapted-optimization-of-novel-targeted-immunotherapy-evaluation-in-high-risk-mcl-100636767","NCT07569965","Frontline Risk-Adapted Optimization of Novel Targeted Immunotherapy Evaluation in High-Risk MCL","Phase II Multicenter Trial of MB-CART2019.1 (Zamtocabtagene Autoleucel) Therapy as Frontline Consolidation for High-Risk Mantle Cell Lymphoma","FRONTIER","Inclusion Criteria:\n\n* Diagnosis of MCL requires histologic confirmation by either overexpression of cyclin D1 OR presence of t(11;14) (q13; q32) translocation\n\n  1. Subject should have a tumor biopsy sample (at least 5 unstained slides of tissue or tissue block) available prior to MB-CART2019.1 infusion, preferably collected pre-induction.\n  2. If archival tissue is not available, the patient may be enrolled after discussion with the protocol chair and\u002For protocol officer\n* High Risk Disease at diagnosis, defined as having at least ONE of the criteria below:\n\n  1. High risk MIPI-c (as calculated by https:\u002F\u002Fwww.european-mcl.net\u002Fhome\u002Fscores-mipi-mipi-c-19.html)\n  2. Simplified MIPI high-risk ≥6.2\n  3. TP53 mutation OR ≥50% TP53 expression by IHC\n  4. Complex Karyotype \\[e.g. 3 or more cytogenetic abnormalities, excluding the presence or absence of t(11:14)\\]\n  5. Ki67≥ 50%\n  6. Blastoid or pleomorphic histology with Ki-67 ≥30%\n  7. Leptomeningeal Disease at diagnosis\n  8. NOTCH1 mutation\n* Received 2 cycles of appropriate systemic induction therapy, which includes a CD20 antibody +\u002F- cytotoxic therapy +\u002F- oral targeted therapy (e.g., BTKi, immunomodulatory imid drugs), with the following considerations:\n\n  1. CD20 antibody alone does not count towards a cycle of treatment\n  2. Induction cycles do not have to be identical\n  3. For BTKis and\u002For lenalidomide a cycle is defined as 14-28 days and will be based on institutional treatment regimens.\n  4. Intrathecal chemotherapy will not count towards a cycle of treatment\n  5. Radiation therapy will not count towards a cycle of treatment\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening. ECOG performance status of 2 at screening is allowed if the decrease in performance status is attributed to lymphoma\n* Disease response assessment of either complete response, partial response, or stable disease by Lugano 2014 criteria assessed by 18F-fluorodeoxyglucose (FDG)-positron emission tomography (PET)\u002Fcomputed tomography (CT) (preferred) or contrast enhanced CT scans including neck\u002Fchest\u002Fabdomen\u002Fpelvis \\[37\\] after 2 cycles of induction therapy. If the participant has history of CNS disease, then he\u002Fshe must have no history of or active parenchymal disease on magnetic resonance imaging (MRI)\n\n  a. Leptomeningeal alone disease is allowable if it is not clinically progressive or worsening from baseline assessment\n* A creatinine clearance (as estimated by direct urine collection, Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\], or Cockcroft-Gault Equation or institutional standard) ≥ 45 mL\u002Fmin\n* Subjects of childbearing or child fathering potential must be willing to practice birth control from the time of enrollment on this study until the follow-up period of the study\n\nExclusion Criteria:\n\n* Unable to give informed consent\n* Any disease progression that occurs during the first 2 induction cycles\n* A creatinine clearance (as estimated by direct urine collection, Chronic Kidney Disease Epidemiology Collaboration \\[CKD-EPI\\], or Cockcroft-Gault Equation or institutional standard) \\\u003C 45 mL\u002Fmin\n* Cardiac ejection fraction (EF) \\\u003C 45% as determined by an echocardiogram (ECHO) or Multigated Radionuclide Acquisition scan (MUGA) (if range is provided, the upper value of the range may be used for assessing eligibility)\n* Resting O2 saturation \\\u003C 92% on room air\n* Serum alanine aminotransferase (ALT) \u002F aspartate aminotransferase (AST) ≥ 5 times the Upper Limit of Normal (ULN) for age\n* Total bilirubin \\>1.5 mg\u002FdL, except in individuals with Gilbert's syndrome\n* Absolute neutrophil count (ANC) \\\u003C 1000\u002FμL unless related to bone marrow infiltration by mantle cell lymphoma. No short-acting granulocyte colony-stimulating factor (G-CSF) use within 7 days of ANC evaluation\n* Platelet count \\\u003C 50,000\u002FµL unless related to bone marrow infiltration or hypersplenism by mantle cell lymphoma. No transfusions within 7 days of assessment.\n* Absolute CD3 count \\\u003C 50\u002FμL at screening\n* Absolute lymphocyte count (ALC) \\\u003C 100\u002FμL within 7 days of apheresis\n* Known history of infection with human immunodeficiency virus (HIV)\n* Known active infection with hepatitis B (hepatitis B surface antigen \\[HBsAg\\] positive). If there is a history of treated hepatitis B, the viral load must be polymerase chain reaction (PCR) negative; antiviral prophylaxis is required if HBsAg negative and anti-hepatitis B core (HBc) positive\n* Known active infection with hepatitis C virus (anti-HCV antibody positive). If patient has a positive hepatitis C antibody, the viral load must be undetectable per quantitative PCR and\u002For nucleic acid testing\n* No seizure history within 6 months prior to enrollment\n* Known history of cerebral vascular accident (CVA) within prior 12 months\n* Known history or presence of autoimmune CNS disease, such as multiple sclerosis, optic neuritis or other immunologic \u002For inflammatory diseases\n* Presence of active CNS disorder that, in the judgment of the investigator, may impair the ability to evaluate neurotoxicity\n* Uncontrolled bacterial, viral, or fungal infection at the time of enrollment.\n\n  a. Uncontrolled is defined as currently taking medication and with progression or no clinical improvement on adequate medical treatment\n* Pregnant or breast-feeding woman\n* Previous or concurrent malignancy with the following exceptions:\n\n  1. Adequately treated basal cell or squamous cell carcinoma (adequate wound healing is required prior to study entry)\n  2. 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  3. Adequately treated breast or prostate carcinoma on hormonal therapies such as Lupron or tamoxifen and in clinical remission of ≥ 2 years -or- low-grade untreated prostate cancer under observation\n  4. A primary malignancy which has been completely resected \u002F treated with curative intent and in complete remission of ≥ 2 years\n  5. Subjects with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with safety and efficacy assessment are eligible for this trial after discussion with protocol chair or protocol officer\n* Severely immunocompromised participants e.g. due to current systemic 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.\n* History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 6 months of enrollment\n* For systemic therapy or radiation therapy, at least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed at the time of scheduled leukapheresis\n* BTKis can be continued through apheresis until one day prior to start of lymphodepletion\n* Baseline neurologic deficits 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 in this study\n* Refusal or inability 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",{"count":210,"type":22},52,[59],"FRONTIER is a prospective, single arm, open label, multi-center, Phase II study of MB-CART2019.1 (Zamtocabtagene Autoleucel) therapy as frontline consolidation for high-risk Mantle Cell Lymphoma (MCL) participants",[30],[71,72,73,79,80,81,85,86,88,91,93,215,216,217,218],"High-risk","Mantle Cell Lymphoma","Frontline","TP53","2026-04-28",{"date":221,"type":39},"2026-05-06",{"date":223,"type":22},"2026-09",{"date":225,"type":22},"2030-03",{"name":102,"class":46},{"id":228,"slug":229,"hasResults":12,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":57,"phases":236,"briefSummary":237,"conditions":238,"keywords":239,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":253},"100426218","phase-1-a-study-of-nx-2127-in-adults-with-relapsedrefractory-b-cell-malignancies-100426218","NCT04830137","A Study of NX-2127 in Adults With Relapsed\u002FRefractory B-cell Malignancies","A Phase 1, Dose Escalation, Safety and Tolerability Study of NX-2127, a Bruton's Tyrosine Kinase (BTK) Degrader, in Adults With Relapsed\u002FRefractory B-cell Malignancies","Inclusion Criteria:\n\n* Patients must be ≥ 18 years of age\n* Patients must have measurable disease per disease-specific response criteria\n* Patients with indolent forms of NHL must meet the criteria requiring systemic treatment (i.e., iwCLL, IWG, Lugano Classification of Lymphoma response criteria, or International PCNSL Collaborative Group response criteria)\n* Patients with transformed lymphoma are eligible for the study with the exception of those detailed in Exclusion Criteria #1: Prolymphocytic leukemia, MCL with blastoid histology, MCL with pleomorphic morphology, or MCL with known TP53 mutation\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (non-PCNSL indications) or 0 - 2 (PCNSL patients)\n* Adequate organ and bone marrow function\n* Patients of child-bearing potential must use adequate contraceptive measures to avoid pregnancy for the duration of the study as defined in the protocol\n\nInclusion Criteria for Patients in Phase 1a:\n\n* Have histologically confirmed R\u002FR CLL, SLL, WM, MCL, and MZL, FL, DLBCL, or PCNSL\n* Received at least 2 prior systemic therapies (or at least 1 prior therapy for patients with WM or PCNSL) and have no other therapies known to provide clinical benefit\n* Must require systemic therapy\n\nInclusion Criteria for Patients in Phase 1b:\n\n* Must have one of the following histologically documented R\u002FR B-cell malignancies:\n\n  * CLL\u002FSLL whose disease has failed treatment with a BTKi;\n  * MCL whose disease has failed treatment with BTKi and an anti-CD20 mAb-based regimen\n  * FL or MZL whose disease has failed treatment with an anti-CD20 mAb-based regimen; or WM whose disease has failed treatment with a BTKi\n  * PCNSL whose disease failed at least 1 prior line of treatment\n  * DLBCL whose disease has failed treatment with an anti-CD20 mAb-based regimen and either: an anthracycline-based regimen; or an anti-CD19-based regimen, or another\u002F palliative regimen (either progressed post stem cell transplant or transplant-ineligible)\n\nExclusion Criteria:\n\n* Active, uncontrolled autoimmune hemolytic anemia or autoimmune thrombocytopenia\n* History of known\u002Fsuspected other autoimmune disease (exception(s): patients with alopecia, vitiligo, resolved childhood atopic dermatitis, hypothyroidism, or hyperthyroidism that is clinically euthyroid at screening are allowed.)\n* Unable to swallow capsules or have a condition that may interfere in the delivery, absorption, or metabolism of the study drug\n* Bleeding diathesis, or other known risk for acute blood loss\n* Patients requiring ongoing treatment with warfarin or an equivalent vitamin K antagonist and within 7 days prior to the first dose of study drug\n* Prior radiotherapy within 2 weeks of planned start of study drug (excluding limited palliative radiation)\n* Toxicities from previous anticancer therapies must have resolved to baseline levels or to Grade 1 (except for alopecia, hypothyroidism with adequate replacement therapy, hypopituitarism with adequate replacement therapy, peripheral neuropathy or hematologic parameters meeting inclusion criteria).\n* Active known second malignancy. Exception: patients with non-metastatic, non-melanoma skin cancer are eligible\n* Patient has had major surgery (e.g. requiring general anesthesia) within 4 weeks before the planned first dose of study drug\n* Infection with human immunodeficiency virus (HIV)-1 or HIV-2. Exception: patients with well-controlled HIV (e.g., CD4 \\> 350\u002Fmm3 and undetectable viral load) are eligible.\n* Current active liver disease from any cause\n* Active viral reactivation (e.g., CMV or EBV)\n* Use of systemic corticosteroids exceeding 20 mg\u002Fday prednisone (or equivalent) for non-PCNSL indications within 15 days prior to the planned start of study drug. PCNSL patients may not exceed corticosteroid doses of 40 mg\u002Fday prednisone (or equivalent) and should be on a stable or decreasing dose for 7 days prior to planned study start.\n* Use of non-steroidal immunosuppressive drugs within 30 days prior to start of the study\n* Clinically significant, uncontrolled cardiac, cardiovascular disease, or history of myocardial infarction within 6 months of planned start of study drug\n* Administration of any strong cytochrome P450 3A (CYP3A) inducers or inhibitors for 14 days prior to the first dose of study drug, and any P-glycoprotein inhibitors (for 2 days) or moderate inducers of CYP3A for 7 days",{"count":235,"type":22},248,[114],"This is a first-in-human Phase 1a\u002F1b multicenter, open-label oncology study designed to evaluate the safety and anti-cancer activity of NX-2127 in patients with advanced B-cell malignancies.",[27,117,119,30,31,29,28,120],[123,124,240,84,241,242,243,128,244,130,131,126,127],"B-cell Malignancy","IMiD","Lenalidomide","Pomalidomide","NX-2127","2026-03-18",{"date":247,"type":39},"2026-03-20",{"date":249,"type":39},"2021-05-05",{"date":251,"type":22},"2027-05",{"name":140,"class":46},16,{"id":255,"slug":256,"hasResults":12,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":4,"eligibilityCriteria":260,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":261,"enrollmentInfo":262,"targetDuration":4,"studyType":57,"phases":264,"briefSummary":265,"conditions":266,"keywords":272,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":47},"100376822","phase-1-car-2019-t-cells-in-patients-with-relapsed-refractory-b-cell-malignancies-100376822","NCT04186520","CAR-20\u002F19-T Cells in Patients With Relapsed Refractory B Cell Malignancies","Phase I\u002FII Study of Tandem, Bispecific Anti-CD19 Anti-CD20 CAR-T Cells for Patients With Relapsed and\u002For Refractory B Cell Malignancies","GENERAL INCLUSION CRITERIA FOR ALL PATIENTS\n\n1. Patients must be aged ≥18 years and ≤80 years with relapsed or refractory B-cell non-Hodgkin Lymphoma.\n2. Absolute cluster of differentiation 3 (CD3) count ≥50 mm\\^3.\n3. Magnetic resonance imaging (MRI) brain and lumbar puncture with cerebrospinal fluid (CSF) analysis by cytology and flow cytometry without evidence of central nervous system (CNS) involvement ONLY in patients with history of CNS involvement or clinical suspicion at the time of enrollment EXCEPT Arm E subjects.\n4. Measurable disease must be documented within four weeks of the time of consent defined as nodal lesions greater than 15 mm in the long axis or extranodal lesions \\>10 mm in long and short axis OR bone marrow involvement that is biopsy proven for B-cell NHL (see separate criteria for CLL and primary\u002Fsecondary CNS lymphoma).\n5. Karnofsky performance score ≥70.\n6. Adequate hepatic function, defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C5 x upper limit of normal (ULN); serum bilirubin and alkaline phosphatase \\\u003C5 x ULN, or considered not clinically significant as per the clinical PIs discretion (e.g. Gilbert's or indirect hyperbilirubinemia) or felt to be due to underlying disease.\n7. ANC≥1000 with no G-CSF within 72 hours or pegylated G-CSF within 14 days.\n8. Platelets≥50,000 with no transfusion within 72 hours.\n9. Adequate renal function, defined as creatinine clearance \\>60 ml\u002Fmin AND serum Cr≤1.5 mg\u002FdL.\n\n   a. No IV hydration within 24 hours of eligibility. b. No dialysis dependent renal failure within three months of planned CAR infusion.\n10. Able to provide written informed consent.\n11. Agree to practice birth control during the study.\n12. Adequate cardiac function as indicated by New York Heart Association (NYHA) classification I or II AND left ventricular ejection fraction of ≥45% (by cardiac echocardiogram (ECHO) or multigated acquisition scan (MUGA)) and adequate pulmonary function as indicated by room air oxygen saturation of ≥92%.\n13. Expected survival \\>12 weeks.\n14. Negative urine or serum pregnancy test in females of child bearing potential at study entry.\n15. Meet criteria regarding fertility and contraception.\n16. No contraindication to central line access.\n17. Patient has demonstrated compliance to other therapies.\n\nPhase 1: 3+3 COHORT ELEGIBILITY CRITERIA\n\n1. Diagnosis of B-cell NHL including Follicular Lymphoma, Marginal Zone Lymphoma (splenic, nodal, extranodal), Mantle Cell Lymphoma, and DLBCL with associated subtypes (aggressive B-cell lymphoma, high grade B-cell lymphoma, T-cell\u002Fhistocyte rich B-cell lymphoma, primary mediastinal B-cell lymphoma, Epstein-Barr virus-positive (EBV+) diffuse large B-cell lymphoma, transformed lymphoma such as transformed follicular or marginal zone, and Richter's transformation).\n2. Patients must have active, measurable disease as defined and meet one of the following criteria.\n\n   1. Must have received Rituximab or another cluster of differentiation 20 (CD20) antibody and at minimum two different chemotherapy regimens appropriate for their disease and be ineligible to receive autologous transplant.\n   2. Relapse post-autologous transplant\n   3. Relapse post-allogeneic transplant\n   4. Patients not previously treated with CAR-T cell therapy\n\nPHASE 1b and 2 COHORT ELEGIBILITY CRITERIA\n\nARM A: Six to nine patient expansion with 8-day manufacturing (Phase 1b)\n\n1. Diagnosis of B-cell NHL including Follicular Lymphoma, Marginal Zone Lymphoma (splenic, nodal, extranodal), and DLBCL with associated subtypes (aggressive B-cell lymphoma, T-cell\u002Fhistocyte rich B-cell lymphoma, primary mediastinal B-cell lymphoma, EBV+ diffuse large B-cell lymphoma, transformed lymphoma such as transformed follicular or marginal zone, and Richter's transformation).\n2. Patients must have active, measurable disease as defined and meet one of the following criteria:\n\n   1. Must have received Rituximab or another cluster of differentiation 20 (CD20) antibody and at minimum two different chemotherapy regimens appropriate for their disease and be ineligible to receive autologous transplant.\n   2. Relapse post-autologous transplant.\n   3. Relapse post-allogeneic transplant.\n   4. Relapse post-anti-cluster of differentiation 19 (CD19) CAR-T cell therapy.\n\n   i. A maximum of two patients with prior CAR-T will be allowed in this cohort.\n\nARM B: Six to nine patient expansion with 12-day manufacturing (Phase 1b)\n\n1\\. Diagnosis of B-cell NHL including Follicular Lymphoma, Marginal Zone Lymphoma (splenic, nodal, extranodal), and DLBCL with associated subtypes (aggressive B-cell lymphoma, high grade B-cell lymphoma, T-cell\u002Fhistocyte rich B-cell lymphoma, primary mediastinal B-cell lymphoma, EBV+ diffuse large B-cell lymphoma, transformed lymphoma such as transformed follicular or marginal zone, and Richter's transformation).\n\n2\\. Patients must have active, measurable disease as defined and meet one of the following criteria:\n\n1. Must have received Rituximab or another CD20 antibody and at minimum two different chemotherapy regimens appropriate for their disease and be ineligible to receive autologous transplant.\n2. Relapse post-autologous transplant.\n3. Relapse post-allogeneic transplant.\n4. Relapse post-anti-CD19 CAR-T cell therapy.\n\ni. A maximum of two patients with prior CAR-T will be allowed in this cohort.\n\nARM C: 24 patient cryopreservation 8\u002F12 flexible manufacturing arm\n\n1. Diagnosis of B-cell NHL including Follicular Lymphoma, Marginal Zone Lymphoma (splenic, nodal, extranodal), and DLBCL with associated subtypes (aggressive B-cell lymphoma, high grade B-cell lymphoma, T-cell\u002Fhistocyte rich B-cell lymphoma, primary mediastinal B-cell lymphoma, EBV+ diffuse large B-cell lymphoma, transformed lymphoma such as transformed follicular or marginal zone, and Richter's transformation).\n2. Patients must have active, measurable disease as defined and meet one of the following criteria a. Must have received Rituximab or another CD20 antibody and at minimum two different chemotherapy regimens appropriate for their disease and be ineligible to receive autologous transplant b. Relapse post-autologous transplant c. Relapse post-allogeneic transplant d. Relapse post-anti-CD19 CAR-T cell therapy i. A maximum of 2 patients with prior CAR-T will be allowed in this cohort\n\nARM D: Phase 1 and Phase 1b: CLL\n\n1\\. Diagnosis of B-cell CLL or small lymphocytic leukemia (SLL) 2. Failed\u002Fprogressed or been intolerant to two prior lines of therapy one of which MUST be either a covalent BTK inhibitor (e.g. ibrutinib, acalabrutinib, zanabrutinib, etc) or BCL2 inhibitors (e.g. venetoclax or other investigational BCL2) 3. Indication for treatment as defined as any of the following:\n\n1. measurable lymph nodes ≥ 1.5 cm in the greatest transverse diameter and\u002For hepatomegaly or splenomegaly)\n2. bone marrow involvement with ≥10% CLL involvement\n\nARM E: Phase 1 and Phase1b Relapsed\u002FRefractory Primary or Secondary CNS Lymphoma\n\n1. Diagnosis of diffuse large B cell lymphoma (DLBCL) with associated subtypes (aggressive B-cell lymphoma, high grade B-cell lymphoma, T-cell\u002Fhistocyte rich B-cell lymphoma, primary mediastinal B-cell lymphoma, EBV+ diffuse large B-cell lymphoma, transformed lymphoma such as transformed follicular or marginal zone, and Richter's transformation) with secondary CNS lymphoma involvement OR primary CNS lymphoma.\n2. For Primary CNS lymphoma, relapsed or refractory following at least one line of CNS-directed therapy.\n3. Secondary CNS lymphoma relapsed or refractory following at least one line of CNS-directed therapy for treatment of CNS lymphoma.\n\n   1. For patients with secondary central nervous system lymphoma (CNSL) with concurrent systemic lymphoma, the concurrent systemic lymphoma must have relapsed following at least 1 prior line of therapy (which must have included an anti-CD20 monoclonal antibody and an anthracycline)\n4. Measurable CNS disease by either lumbar puncture (LP) with positivity in CNS by flow cytometry or morphology for lymphoma cells OR magnetic resonance imaging (MRI) with enhancing lesions ≥1 cm in size consistent with lymphoma\n5. Must have had prior treatment with high dose methotrexate defined as methotrexate given intravenously at a dose ≥2500 mg\u002Fm\\^2 and either progression\u002Frelapse, stable disease, or intolerance to at least one cycle of treatment.\n\nPhase II Cohort: Mantle Cell Lymphoma\n\n1\\. Diagnosis of Mantle Cell Lymphoma. 2. Patients must have active, measurable disease as previously defined and have relapsed, refractory disease as defined as one of the following:\n\n1. Relapsed disease after two lines of cytotoxic chemotherapy including administration of anti-CD20 antibody.\n2. Progressive disease after ≥second line Bruton tyrosine kinase (BTK) inhibitor.\n3. Relapse post-autologous transplant.\n4. Relapse post-allogeneic transplant.\n5. Relapse post anti-CD19 CAR-T cell therapy.\n\ni. A maximum of four patients with history of prior anti-CD19 CAR-T will be allowed in this cohort.\n\nEXCLUSION CRITERIA (ALL PATIENTS)\n\nA potential subject who meets any of the following exclusion criteria is ineligible to participate in the study.\n\n1. Positive beta- human chorionic gonadotropin (HCG) in female of childbearing potential.\n2. Confirmed active human immunodeficiency virus (HIV), Hepatitis B or C infection.\n3. History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon requiring steroid therapy defined as \\>20 mg of prednisone or equivalent daily.\n4. Presence of ≥grade 3 non-hematologic toxicities as per CTCAE version 5.0 from any previous treatment unless it is felt to be due to underlying disease.\n5. Concurrent use of investigational therapeutic agents or enrollment on another therapeutic clinical trial at any institution. Minimum of 14 days or 5 half-lives of the drug (whichever is shorter) washout prior to apheresis.\n6. Refusal to participate in the long-term follow-up protocol\n7. Patients with active CNS involvement by malignancy on MRI or by lumbar puncture (Not applicable to Arm E cohort.)\n\n   a. Patients with prior CNS disease that has been effectively treated will be eligible providing treatment was \\>4 weeks before enrollment and a remission documented within 8 weeks of planned CAR-T cell infusion by MRI brain and CSF analysis.\n8. Previous recipients of allogeneic hematopoietic stem cell transplantation (AHCT) are excluded if they are \\\u003C100 days' post-transplant, have evidence of active graft-versus-host-disease (GVHD) of any grade, or are currently on immunosuppression.\n9. Prior allogeneic CAR T-cell therapy\n10. Previous recipients of autologous CAR-T cell therapy directed at either CD19 or CD20 are excluded if they are \\\u003C100 days post prior CAR-T cell treatment (does not include re-enrollment) or have \\>5% residual circulating CAR-T as measured by flow cytometry using a CD19 CAR detection reagent (Miltenyi Biotec)\n\n    a. Patients with prior CAR-T treatment against CD19 or CD20 must have repeat biopsy post-CAR-T cell therapy confirming a minimum of 5% CD19 or CD20 positivity by immunohistochemistry or flow cytometry\n11. Anti-CD20 antibody treatment within 4 weeks of cell infusion\n12. Anti-CD19 antibody treatment within 4 weeks of cell infusion\n13. Cytotoxic chemotherapy other than lymphodepletion within 14 days of CAR-T cell infusion\n14. Cytotoxic chemotherapy treatment within 14 days or steroid treatment (other than replacement dose steroids) within 7 days prior to apheresis collection for CAR-T cells\n15. Oral chemotherapeutic agents or antibody directed treatment within 7 days of apheresis\n\n    a. BTK inhibitors are allowed until 1-day prior to apheresis and can re-start until 1-day prior to lymphodepletion\n16. Patients post solid organ transplant who develop high grade lymphomas or leukemias\n17. Concurrent active malignancy other than basal or squamous cell carcinomas of the skin (underlying low-grade lymphoma chronic lymphocytic leukemia\u002Ffollicular lymphoma (FL)\u002Fmarginal zone lymphoma (MZL) is allowable in patients with transformed large cell lymphoma)\n\nSPECIAL CRITERIA REGARDING FERTILITY AND CONTRACEPTION\n\nFemale subjects of reproductive potential (women who have reached menarche or women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within the preceding 24 months, or have not undergone a sterilization procedure \\[hysterectomy or bilateral oophorectomy\\]) must have a negative serum or urine pregnancy test performed as part of eligibility criteria Due to the high-risk level of this study, while enrolled, all subjects must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization). Additionally, if participating in sexual activity that could lead to pregnancy, the study subject must agree to use reliable and double barrier methods of contraception during the follow-up period of the protocol.\n\nAcceptable birth control includes a combination of two of the following methods:\n\n* Condoms (male or female) with or without a spermicidal agent.\n* Diaphragm or cervical cap with spermicide\n* Intrauterine device (IUD)\n* Hormonal-based contraception Subjects who are not of reproductive potential (women who are premenarche or have been post-menopausal for at least 24 consecutive months or have undergone hysterectomy tubal ligation, salpingectomy, and\u002For bilateral oophorectomy or men who have documented azoospermia) are eligible without requiring the use of contraception","80 Years",{"count":263,"type":22},100,[114,59],"This is a Phase I\u002FII, interventional, single-arm, open-label, treatment study designed to evaluate the safety and efficacy of Interleukin-7 and Interleukin-15 (IL-7\u002FIL-15) manufactured chimeric antigen receptor (CAR)-20\u002F19-T cells as well as the feasibility of a flexible manufacturing schema in adult patients with B cell malignancies that have failed prior therapies.",[267,30,27,268,269,270,271,67],"Non Hodgkin Lymphoma (NHL)","Follicular Lymphoma","Marginal Zone Lymphoma","Diffuse Large B Cell Lymphoma","Primary Mediastinal Large B-cell Lymphoma (PMBCL)",[273,274,275,159],"CAR-T","Chimeric antigen receptor T-cell therapy","CAR Therapy","2026-02-19",{"date":278,"type":39},"2026-02-23",{"date":280,"type":39},"2020-05-18",{"date":282,"type":22},"2029-02-28",{"name":284,"class":285},"Medical College of Wisconsin","OTHER",{"id":287,"slug":288,"hasResults":12,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":292,"eligibilityCriteria":293,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":261,"enrollmentInfo":294,"targetDuration":4,"studyType":57,"phases":296,"briefSummary":298,"conditions":299,"keywords":302,"overallStatus":191,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":4},"100624651","this-clinical-trial-is-a-single-arm-non-randomized-pilot-trial-to-determine-the-safety-of-administering-autologous-anti-c19-cells-ari-0001-and-the-feasibility-of-local-car-t-cell-production-in-patients-over-18-years-of-age-with-relapsedrefractory-rr-cd19-hematologic-malignancies-including-r-100624651","NCT07412405","This Clinical Trial is a Single-arm, Non-randomized Pilot Trial to Determine the Safety of Administering Autologous Anti-C19 Cells (ARI-0001) and the Feasibility of Local CAR-T Cell Production in Patients Over 18 Years of Age With Relapsed\u002FRefractory (R\u002FR) CD19+ Hematologic Malignancies, Including R","ACITAC-001: Hybrid Type Two Implementation Study of CAR-T Therapy in Colombia Based on a Pilot Clinical Trial ARI-0001 T Cells With Anti-CD19 Chimeric Antigen Receptor (CAR-T) for the Treatment of Recurrent\u002FRefractory CD19+ Hematolymphoid Neoplasms.","ACITAC-001","Inclusion Criteria:\n\n1. Participants (Men and Women) ≥ 18 and ≥ 80 years of age.\n2. Participants capable of understanding and voluntarily signing the informed consent forms (prescreening and study forms) prior to any study-related evaluation or procedure, and able to adhere to the study visit schedule and other protocol requirements.\n3. CD19+ hematologic malignancy with a histologically documented diagnosis.\n4. Inclusion criteria according to the type of CD19+ hematologic malignancy measurable by the 2014 Lugano criteria (NHL) or IWCLL criteria (CLL) or EWALL criteria (ALL).\n5. B-cell precursor acute lymphoblastic leukemia (B-ALL relapsed\u002Frefractory (R\u002FR)): Second-line or later relapse (including patients with prior blinatumumab use), second-line or later non-candidate for allogeneic transplantation, or relapse post-allogeneic transplantation.\n6. For patient inclusion, the disease must have progressed after the last regimen or the patient must not have achieved partial or complete remission with the last regimen, defined by the presence of at least 5% blasts in bone marrow or peripheral blood in an evaluation confirmed by flow cytometry or immunohistochemistry at least 2 weeks prior to recruitment (prescreening visit).\n7. The consideration of non-candidacy for allogeneic transplantation will be based on functional status, comorbidities, and persistence. Minimal Residual Disease (MRD) or lack of a donor.\n8. Relapsed\u002Frefractory diffuse large B-cell lymphoma (DLBCL) and high-grade lymphoma (R\u002FR): Refractory to first-line treatment or relapsed within the first 12 months after completion of first-line chemoimmunotherapy, including an anti-CD20 monoclonal antibody, not a candidate for autologous transplantation; or refractory after two or more lines of systemic therapy; in second (or higher) relapse post-autologous transplantation; grade 3b follicular lymphoma or transformed to relapsed or refractory large B-cell lymphoma after at least one line of standard treatment.\n9. Symptomatic relapsed\u002Frefractory follicular lymphoma (FL): In third-line therapy (after at least two treatment regimens), including anti-CD20 therapy, and with a progression-free interval of less than two years; or in Relapse after autologous or allogeneic transplantation.\n10. Relapsed\u002Frefractory (R\u002FR) mantle cell lymphoma, including Bruton's tyrosine kinase inhibitor (BTKi) therapy: In first (or higher) relapse, not a candidate for autologous or allogeneic transplantation; or in second (or higher) relapse following autologous or allogeneic transplantation.\n11. Symptomatic chronic lymphocytic leukemia (CLL): Relapse after two treatment regimens (including BTKi and BCL2 inhibitor in combination with anti-CD20) and with a progression-free interval of less than two years (POD24); or transformation to Richter syndrome, see inclusion criteria for DLBCL.\n12. Eastern Cooperative Oncology Group (ECOG) functional status ≤ 2.\n13. Life expectancy \\> 6 months, as determined by the Principal Investigator.\n14. Adequate organ function, defined as the following parameters at visit 2 Selection criteria:\n\n    1. Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm3\n    2. Platelet count ≥ 50,000\u002Fmm3\n    3. Hemoglobin ≥ 10 g\u002FdL\n    4. Total bilirubin ≤ 1.5 x the institutional upper limit of normal (ULN).\n    5. AST (SGOT)\u002FALT (SGPT) ≤ 3 x the institutional ULN\n    6. Serum creatinine ≤ 2 x the institutional ULN or eGFR \\> 30 mL\u002Fmin\u002F1.73 m2\n    7. Left ventricular ejection fraction \\> 45% as determined by echocardiogram\n    8. Pulmonary function tests: FEV1 (forced expiratory volume in 1 second): ≥ 50% of predicted and FVC (forced vital capacity): ≥ 50% of predicted Predicted value and FEV1\u002FFVC ratio: ≥ 0.7 (or without significant obstruction) and SpO2 (oxygen saturation): ≥ 89% on room air at rest and hemoglobin-corrected DLCO: ≥ 70% of the predicted value.\n15. Have adequate venous access.\n16. Participants of reproductive potential must meet the following criteria:\n\n    1. Negative pregnancy test 14 days before trial enrollment and subsequently every month for the duration of the trial, or evidence of postmenopausal status or surgical sterilization.\n    2. Postmenopausal status is defined as the absence of menstruation for 12 months without an alternative medical cause. The following age-specific requirements apply:\n\n       * \\\u003C 50 years: Amenorrhea for ≥12 months after discontinuation of exogenous hormonal treatments; and luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels within the postmenopausal range as defined by the institution.\n       * ≥ 50 years: Patient with amenorrhea for 12 months or more after discontinuation of all exogenous hormonal treatments; or radiation-induced menopause with last menstrual period more than 1 year ago; or chemotherapy-induced menopause with last menstrual period more than 1 year ago.\n17. All participants of reproductive potential and those with a sexual partner of reproductive potential must agree to use a highly effective contraceptive method from the start of trial therapy until 12 months after the last infusion dose. Options for adequate contraception with a failure rate of \\\u003C1% per year include: bilateral tubal ligation\u002Focclusion; partner vasectomy; intrauterine device (IUD) or hormonal delivery system (IUS); any hormonal contraceptive (estrogen combined with progesterone or progesterone alone) combined with ovulation inhibition: implanted, oral, intravaginal, transdermal, or injectable; spermicide with a compatible barrier method (e.g., diaphragm, sponge, or condoms). Alternatively, two methods (e.g., two barrier methods, such as a condom and a cervical cap) may be combined to achieve a failure rate of \\\u003C1% per year. Barrier methods must always be supplemented with the use of spermicide. Abstinence is acceptable only if it is consistent with the patient's preferred and usual lifestyle. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulatory methods) and withdrawal are not acceptable contraceptive methods. If pregnancy is suspected or confirmed in a female patient or a female partner of a male patient during trial participation or within 12 months of ARI-0001 cell infusion, the Principal Investigator must be informed immediately.\n18. Participants with prior or resolved HBV infection (defined as the presence of hepatitis B core antibody \\[anti-HBc\\] and absence of HBsAg) are eligible.\n\n\\*Specific Inclusion Criteria Before Lymph Depletion\\*\n\nThe following criteria must be confirmed 7 days prior to lymph depletion:\n\n1. Confirmation of successful CAR-T cell fabrication.\n2. No evidence or suspicion of infection.\n3. Serum creatinine ≤ 2 times the institutional upper limit of normal (ULN) or eGFR \\>30 mL\u002Fmin\u002F1.73 m².\n4. Confirmation of compliance with washout periods.\n5. No worsening of the patient's clinical status compared to the initial eligibility criteria that, in the opinion of the treating physician, significantly increases the risk due to lymph depletion chemotherapy or excludes them from treatment with the trial CAR-T cell therapy.\n\n\\*Specific inclusion criteria prior to CAR-T cell infusion.\\*\n\nParticipants must meet the following criteria (Failure to meet these criteria will result in the individual subject's enrollment being halted or suspended entirely at the discretion of the CES and the Principal Investigator):\n\n1. No evidence or suspicion of infection.\n2. Confirmation of compliance with the washout periods.\n3. No worsening of clinical status compared to the initial eligibility criteria that, in the opinion of the treating physician, significantly increases the risk due to lymphodepleting chemotherapy or excludes them from treatment with the ARI-0001 CAR-T therapy in the trial.\n\nExclusion Criteria:\n\nThe presence of any of the following will exclude the subject from trial enrollment:\n\n1. Failure to comply with the washout periods.\n2. Autologous or allogeneic stem cell transplantation or CAR-T cell therapy within 6 weeks prior to CAR-T cell infusion.\n3. Subjects with an active infection requiring systemic treatment. This definition excludes participants with Hepatitis B (known positive hepatitis B surface antigen \\[HBsAg\\] result), latent Tuberculosis, Hepatitis C, or HIV seropositivity.\n4. History of autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus) requiring immunosuppressive medication within the past 6 months.\n5. Pregnant or breastfeeding women are excluded from this trial because CAR-T cell therapy may be associated with teratogenic or abortifacient effects. Women of childbearing potential must have a negative serum pregnancy test. Due to the unknown, but potential, risk of adverse events in infants from maternal CAR-T cell therapy, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this trial.\n6. Participation in another interventional research study.\n7. Major surgery within 4 weeks prior to enrollment from which the patient has not fully recovered, as determined by the investigator.\n8. Active central nervous system (CNS) involvement due to leukemia or lymphoma, including leptomeningeal lymphoma. Patients with a history of CNS or meningeal involvement must be in documented remission, as determined by cerebrospinal fluid (CSF) evaluation, for at least 90 days prior to enrollment.\n9. Diagnosis of another malignancy within ≤ 5 years prior to trial enrollment, except for those considered adequately treated with no evidence of disease or symptoms and\u002For not requiring therapy during the trial (e.g., basal cell or squamous cell skin cancer, carcinoma in situ of the breast, bladder, or cervix, or low-grade prostate cancer with a Gleason score ≤ 6).\n10. Known brain metastases or cranial epidural disease. Note: Patients with brain metastases or cranial epidural disease adequately treated with radiotherapy and\u002For surgery and stable for at least 4 weeks prior to the first dose of trial treatment will be eligible for the trial. Subjects must be neurologically asymptomatic and not receiving corticosteroid treatment at the time of the first dose of trial treatment.\n11. Current evidence of significant uncontrolled comorbidity, including, but not limited to, the following conditions:\n\n    * New York Heart Association Class III or IV congestive heart failure, unstable angina, serious cardiac arrhythmias.\n    * Stroke (including transient ischemic attack \\[TIA\\]), myocardial infarction (MI), or other ischemic events, or thromboembolic event (e.g., deep vein thrombosis, pulmonary embolism) within 3 months prior to the first dose.\n    * QTc prolongation defined as QTcF \\> 500 ms.\n    * Known congenital long QT syndrome.\n    * Left ventricular ejection fraction \\\u003C 45%.\n    * Uncontrolled hypertension, defined as ≥ 140\u002F90 mmHg as assessed by the average of three consecutive blood pressure measurements taken over 10 minutes.\n    * Any other condition that, in the Investigator's judgment, contraindicates the subject's participation in the clinical trial due to safety concerns or issues with compliance with clinical trial procedures (e.g., infection\u002Finflammation, bowel obstruction, inability to swallow medication \\[subjects cannot receive the medication via a feeding tube\\], social\u002Fpsychological problems, etc.).",{"count":295,"type":22},12,[297],"NA","This is a hybrid type two study, with two simultaneous development phases. Phase A involves developing a public-private partnership to create the conditions for implementing CAR-T cell therapies in Colombia. Phase B will be a single-arm, non-randomized pilot clinical trial in patients over 18 years of age with recurrent\u002Frefractory (R\u002FR) CD19+ hematopoietic lymphoid neoplasms, including R\u002FR non-Hodgkin lymphoma (NHL), R\u002FR B-cell acute lymphoblastic leukemia (B-ALL), and R\u002FR mantle cell lymphoma; and R\u002FR chronic lymphocytic leukemia (CLL) (including CLL with Richter transformation). This trial aims to determine the safety of administering autologous anti-C19 cells (ARI-0001) and the feasibility of local CAR-T cell production.\n\nPhase A of implementation aims to gather information on the domains of the multilevel model, including organizational context, suppliers, infrastructure, and institutional capacities, to identify barriers and facilitators in the implementation of CAR-T cell therapy in Colombia. National consensus will also be developed in the scientific, clinical, administrative, and regulatory spheres.\n\nPhase B will involve a pilot clinical trial in patients with relapsed\u002Frefractory CD19-positive hematopoietic lymphoid neoplasms. The production of ARI-0001 cells consists of the genetic modification of autologous T cells through lentiviral transduction of a chimeric antigen receptor (CAR) targeting the CD19 surface antigen. The process is carried out in the CliniMACS Prodigy® closed transduction system, which for this study will be located at and operated by staff from the District Institute of Science, Biotechnology, and Innovation in Health (IDCBIS). This pilot clinical trial will use an open-label, single-arm, staggered enrollment design with a safety observation period. The patient will receive the cell product infusion following administration of a lymphodepletion regimen at the National Cancer Institute (NCI). The patient will remain hospitalized for 14 days after the CAR-T cell infusion ARI-001 for medical monitoring, with subsequent outpatient follow-up until 12 months post-infusion.\n\nSubsequently, the patient will be offered a new informed consent process to participate in outpatient follow-up for up to 15 years.",[300,29,30,184,301],"Adult B-cell Acute Lymphoblastic Leukemia","Chronic Lymphocytic Leukemia",[303,304,305,306,273,307,84,308,309],"Pilot","Implementation","Safety","ARI-0001","CD19","Leukemia","Colombia","2026-02-11",{"date":312,"type":39},"2026-02-17",{"date":314,"type":22},"2026-09-01",{"date":316,"type":22},"2029-09-01",{"name":318,"class":285},"GUSTAVO SALGUERO",{"id":320,"slug":321,"hasResults":12,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":326,"targetDuration":4,"studyType":57,"phases":328,"briefSummary":329,"conditions":330,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":342},"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":327,"type":22},42,[114],"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",[331,332,30,185,31],"Non-Hodgkin Lymphoma Refractory\u002F Relapsed","DLBCL - Diffuse Large B Cell Lymphoma","2026-02-06",{"date":335,"type":39},"2026-02-10",{"date":337,"type":39},"2026-01-29",{"date":339,"type":22},"2028-02",{"name":341,"class":46},"LTZ Therapeutics, Inc.",5,{"id":344,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":345,"targetDuration":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":346,"keywords":347,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":352,"leadSponsor":353,"locationsCount":47},"100519397",{"count":21,"type":22},[27,28,29,30,31,32],[34],"2026-01-26",{"date":350,"type":39},"2026-01-28",{"date":41,"type":39},{"date":43,"type":22},{"name":45,"class":46},{"id":355,"slug":356,"hasResults":12,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":4,"eligibilityCriteria":360,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":361,"enrollmentInfo":362,"targetDuration":4,"studyType":57,"phases":364,"briefSummary":365,"conditions":366,"keywords":368,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":382},"100598901","phase-2-relmacabtagene-autoleucel-combined-with-sintilimab-for-relapsedrefractory-b-cell-lymphoma-100598901","NCT07077512","Relmacabtagene Autoleucel Combined With Sintilimab for Relapsed\u002FRefractory B-cell Lymphoma","A Single-arm, Phase II Clinical Study of Relmacabtagene Autoleucel Combined With Sintilimab for Relapsed\u002FRefractory B-cell Lymphoma.","Inclusion Criteria:\n\n1. The patient must be aware of and voluntarily sign the informed consent form (ICF).\n2. Aged between 18 and 70 years, both male and female.\n3. Pathologically diagnosed with DLBCL, FL, or MCL, with histological confirmation of CD19 positivity (immunohistochemistry or flow cytometry, with flow cytometry used for re-evaluation if immunohistochemistry is CD19-negative).\n4. The patient must be willing to receive regorafenib and sintilimab treatment and be deemed suitable for this treatment by the investigator.\n5. Relapsed\u002Frefractory DLBCL, FL, or MCL.\n6. At least one measurable or evaluable lesion.\n7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.\n8. Expected survival of ≥3 months.\n9. Adequate function of the heart, lungs, liver, kidneys, and other organs.\n\nExclusion Criteria:\n\n1. History of another malignancy that has not been in complete remission for at least 2 years, except for: non-melanoma skin cancer, completely resected stage I tumors with low recurrence potential, treated localized prostate cancer, biopsy-confirmed cervical carcinoma in situ, or squamous intraepithelial lesions detected by Pap smear and so on.\n2. Active Hepatitis B: a) Positive for Hepatitis B surface antigen (HBsAg) and\u002For Hepatitis B core antibody (HBcAb) , with HBV-DNA below the lower limit of the reference value can be included.\n3. Hepatitis C, HIV, or syphilis infection.\n4. Uncontrolled systemic fungal, bacterial, viral, or other infections.\n5. Acute or chronic graft-versus-host disease (GVHD).\n6. Known hypersensitivity or allergy to any study drug or excipient.\n7. Clinically significant central nervous system (CNS) disease or symptoms, such as epilepsy, seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychiatric illness.\n8. Pregnant or breastfeeding women, and women of childbearing age who do not wish to use contraception.\n9. Mentally ill individuals or those unable to provide informed consent.\n10. The investigator deems the patient unsuitable for the study due to medical, psychological, familial, social, or geographical reasons or an inability to comply with the study protocol.\n11. Previous CAR-T cell therapy or other gene-modified T-cell treatments.\n12. Previous CD19-targeted therapy.\n13. Previous allogeneic hematopoietic stem cell transplantation.","70 Years",{"count":363,"type":22},30,[59],"This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of Relmacabtagene Autoleucel in combination with the Sintilimab regimen for the treatment of relapsed\u002Frefractory B-cell lymphoma",[367,30,185],"Large B Cell Diffuse Lymphoma",[369,370,371,372],"Relmacabtagene Autoleucel","Sintilimab","CD19 Positive","B cell lymphoma","2026-01-20",{"date":375,"type":39},"2026-01-21",{"date":377,"type":39},"2025-09-15",{"date":379,"type":22},"2027-07-15",{"name":381,"class":285},"Sun Yat-sen University",3,{"id":384,"slug":385,"hasResults":12,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":4,"eligibilityCriteria":389,"healthyVolunteers":12,"sex":18,"minAge":390,"maxAge":4,"enrollmentInfo":391,"targetDuration":4,"studyType":57,"phases":393,"briefSummary":394,"conditions":395,"keywords":399,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":403,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":47},"100446836","phase-1-preliminary-safety-and-tolerability-of-cd19x22-car-t-cells-in-adolescent-and-adult-rr-b-nhl-patients-100446836","NCT05098613","Preliminary Safety and Tolerability of CD19x22 CAR T Cells in Adolescent and Adult R\u002FR B-NHL Patients","Phase 1 Study of Bispecific CD19 and CD22 Chimeric Antigen Receptor Co-Expressing T Cells (CD19x22 CAR T) in Adolescent and Adult Patients With Relapsed and\u002For Refractory B-Non-Hodgkin's Lymphoma (B-NHL)","Inclusion Criteria:\n\n1\\. Age: ≥ 16 years of age with no upper age limit. (NOTE: the first three subjects on this trial must be ≥ 18 years of age.)\n\nCOHORT 1: Non-CNS B-NHL\n\n1. Histologically confirmed aggressive B-cell NHL including the following types defined by World Health Organization (WHO) 2008:\n\n   a. Diffuse Large B-Cell Lymphoma (DLBCL) not otherwise specified; T cell\u002Fhistiocyte rich large B cell lymphoma; DLBCL associated with chronic inflammation; Epstein Barr Virus (EBV)+ DLBCL of the elderly; OR b. Primary mediastinal (thymic) large B cell lymphoma; OR c. Transformation to DLBCL; OR d. High grade B-cell Lymphoma (HGBL).\n2. Subjects must not have any signs or symptoms of CNS disease or detectable evidence of CNS disease on magnetic resonance imaging (MRI) at screening; subjects who have been previously treated for CNS disease, but have no evidence of disease at screening are eligible for this cohort.\n3. Subjects must have disease progression confirmed by either flow cytometry or immunohistochemistry (IHC), disease stabilization, or disease recurrence after at least two lines of therapy.\n\n   a. The two lines of prior therapy must include an anthracycline and anti-CD20 monoclonal antibody treatment.\n\n   b. Relapse or refractory after single antigen targeting CAR T cell therapy\n4. Must have evaluable or measurable disease according to the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma; lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy.\n\nCOHORT 2: MANTLE CELL LYMPHOMA (MCL)\n\n1. Mantle Cell Lymphoma (MCL).\n\n   a. Results of all tests conducted on the tissue at initial diagnosis and\u002For relapse, including, but not limited to, the MCL subtype (classic and blastoid), Ki-67 proliferation index, and TP53 mutation status should be provided if done.\n2. Subjects must have relapsed and\u002For refractory MCL confirmed by either flow cytometry or immunohistochemistry (ICH), disease stabilization, or disease recurrence after at least two lines of therapy including any combination of the agents below:\n\n   a. An anti-CD20-directed therapy b. A BTK inhibitor c. Anthracycline or Bendamustine d. Relapse or refractory after single antigen targeting CAR T cell therapy.\n3. Must have evaluable or measurable disease according to the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma; lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy. MCL patients without measurable nodal or extranodal disease by IWG criteria are eligible if they have bone marrow involvement of MCL at relapse\n\nCOHORT 3: PRIMARY CNS LYMPHOMA OR SECONDARY CNS LYMPHOMA\n\n1. Subjects with relapsed and\u002For refractory primary CNS lymphoma (PCNSL) OR secondary CNS lymphoma (SCNSL), as defined by the following:\n\n   a. Absence of measurable disease outside the CNS, as determined by radiographic imaging (i.e. PET\u002FCT).\n\n   b. Detectable CNS disease, as defined as: i. At least 1 site of measurable disease within the brain or spinal cord that is ≥ 1 cm in the longest diameter based on MRI or PET\u002FCT imaging; OR, ii. Neoplastic B-cells detectable within the CSF or vitreous by flow cytometry or cytology.\n2. Subjects must have disease progression confirmed by either flow cytometry or immunohistochemistry (IHC), disease stabilization, or disease recurrence after at least one line of therapy.\n\nALL COHORTS:\n\n1. Subjects who have undergone autologous stem cell transplantation (SCT) with disease progression or relapse are eligible.\n2. Subjects who have undergone allogeneic SCT will be eligible if, in addition to meeting other eligibility criteria, are:\n\n   1. At least 100 days post-transplant,\n   2. Do not have active graft versus host disease (GVHD)\n3. Any standard of care systemic therapy prior to leukapheresis must follow the washout period.\n4. Any steroid use (dexamethasone or prednisone) prior to apheresis must follow the washout period. Physiological replacement doses are allowable with no washout period. Topical or inhaled steroids for localized GVHD is allowable.\n5. Peripheral blood CD3 count must be \\>0.15 x 10 (to the 6th) cells\u002FmL within 14 days prior to proceeding with apheresis.\n6. Toxicities from prior therapy must be stable and recovered to ≤ grade 1 (exceptions include non-clinically significant toxicities such as alopecia and the organ function definitions provided in inclusion criteria 12).\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, or Karnofsky ≥ 80%.\n8. Adequate organ function as defined by:\n\n   1. Absolute neutrophil count (ANC) ≥ 500\u002FμL\n   2. Platelet count ≥ 50,000\u002F μL.\n   3. Renal: Creatinine ≤ 2 mg\u002FdL OR creatinine clearance (as estimated by Cockcroft Gault equation) ≥ 60 mL\u002Fmin.\n   4. Hepatic: Serum alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) ≤ 3 upper limit of normal (ULN).\n   5. Total bilirubin ≤ 2 mg\u002Fdl, except in subjects with Gilbert's syndrome where a bilirubin \\\u003C4.0 will be acceptable.\n   6. Cardiac: Ejection fraction ≥ 40%, no evidence of physiologically significant pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings within 6 weeks of apheresis.\n   7. Pulmonary: No clinically significant pleural effusion and;\n\n   i. Baseline oxygen saturation must be \\> 92% on room air\n9. Females of childbearing potential must have a negative serum pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 6 months are not considered to be of childbearing potential).\n10. Subjects of childbearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for 12 months after receiving the CD19x22 infusion; females of childbearing potential must have a negative pregnancy test.\n\n21\\. Must be able to give informed consent; subjects unable to give informed consent will not be eligible for this study.\n\n22\\. Be able to consent to long-term follow-up protocol (#20-0188).\n\nExclusion Criteria:\n\n1. Age \\\u003C 16 years of age.\n2. Patient who is intolerant of contrast-enhanced MRI due to allergic reactions to contrast agents. Only applicable to Cohort 3.\n3. History of other malignancies, unless they have been disease free for at least 3 years. Exceptions include non-melanoma skin cancer or carcinoma in situ and localized prostate cancer not on active treatment.\n4. Uncontrolled fungal, bacterial, viral, or other infection requiring antimicrobials for management; uncomplicated infections are permitted if responding to active treatment.\n5. Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (hepatitis B surface antigen \\[HBsAg\\] positive) or hepatitis C.\n6. History of known myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment or have cardiac atrial or cardiac ventricular lymphoma involvement.\n7. Venous thrombosis or embolism not managed on a stable regimen of anticoagulation.\n8. Any medical condition that in the judgement of the sponsor is likely to interfere with assessment of safety or efficacy of study treatment.\n9. History of severe immediate hypersensitivity reaction to any of the agents used in this study.\n10. Pregnancy (serum pregnancy test must be obtained at time of enrollment for females of childbearing potential and to be repeated 72 hours prior to lymphodepleting chemotherapy regimen); females who have undergone surgical sterilization or who have been postmenopausal for at least 6 months are not considered to be childbearing potential.\n11. Lactating.\n12. In the investigator's judgment, the subject is unlikely to complete all protocol required study visits or procedures, including follow up visits, or comply with the study requirements for participation.\n13. Unwilling to participate in long-term follow-up protocol that is required if CAR T cell therapy is administered at CU Anschutz.\n\nLYMPHODEPLETING CHEMOTHERAPY ELIGIILITY:\n\nIn order to proceed with lymphodepleting chemotherapy, enrolled participants must meet all eligibility criteria below within 72 hours prior to lymphodepletion, unless otherwise specified:\n\n* If the participant received bridging therapy after apheresis, confirmation of disease reevaluation is required. It must be within 6 weeks of initiation of LD chemotherapy.\n\n  * Confirmation that the participant has met the washout period for bridging therapy.\n* Negative serum pregnancy test (for women of childbearing potential)\n* Adequate organ function as defined by:\n\n  * Absolute neutrophil count (ANC) ≥ 500\u002FμL.\n  * Platelet count ≥ 50,000\u002F μL.\n  * Renal: Creatinine ≤ 2 mg\u002FdL OR creatinine clearance (as estimated by Cockcroft Gault equation) ≥ 60 mL\u002Fmin.\n  * Hepatic: Serum alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) ≤ 3 upper limit of normal (ULN).\n  * Total bilirubin ≤ 2 mg\u002Fdl, except in subjects with Gilbert's syndrome where a bilirubin \\\u003C3.0 will be acceptable.\n  * Pulmonary: No clinically significant pleural effusion and; Baseline oxygen saturation must be \\> 92% on room air.\n  * Cardiac: Ejection fraction ≥ 45%, no evidence of physiologically significant pericardial effusion as determined by an echocardiogram (ECHO) (only if subject received bridging anthracycline or developed a significant illness prior to LD-chemo per investigator assessment.) If clinically indicated, ECHO must be performed within 2 weeks prior to LD-chemotherapy.\n\nCD19x22 CAR T CELL INFUSION ELIGIBILITY\n\nIn order to proceed with CD19x22 CAR T Cell Infusion, enrolled participants must meet all eligibility criteria below within 24 hours prior to CD19x22 CAR T Cell infusion, unless otherwise specified:\n\n* CD19x22 CAR T cells must have met manufacturing release criteria (unless prospectively approved by IND Sponsor, Gates Institute Medical Lead, and FDA).\n* Confirmation that the site has Anakinra and Ruxolitinib in stock and available (should IEC-HS treatment be required).\n* ECOG ≤2 or Karnofsky≥ 50%.\n* Clinically stable without evidence of vital sign instability, including the lack of supportive vasoactive drugs or intensive care unit support.\n* Oxygen saturation \\> 92% on room air; cannot be on supplemental oxygen.\n* No evidence of uncontrolled, significant tumor lysis syndrome prior to cell infusion per investigator assessment.\n* No evidence of rapidly progressive NHL per investigator determination.\n* Participants' temperature is \\\u003C38.0 °C within 48 hours prior to cell infusion. (If the source of fever cannot be identified \\[after thorough infectious disease work-up\\], and the suspected cause is underlying malignancy, discussion and approval by the Gates Institute Medical Lead may allow continued infusion of CD19x22 cells. This should be appropriately documented in the patient's medical record.\n* Liver transaminase (ALT and AST) \\\u003C 5 x institutional ULN (\\\u003C grade 3) based on age- and laboratory- specific normal ranges.\n* Adequate renal function as defined by creatinine ≤ 2 mg\u002FdL OR creatinine clearance (as estimated by the Cockcroft- Gault equation) ≥ 60 mL\u002Fmin.\n\nIf these criteria are not met, measures can be taken to resolve the underlying condition(s). If successful, cells may be infused up to (and including) 7 days following the time of the planned infusion with no additional lymphodepletion. If the CD19x22 CAR T Cell infusion is delayed more than 7 days, lymphodepleting chemotherapy MAY be repeated, per the investigator's discretion. Prior to commencing a second round of lymphodepletion, participants must meet lymphodepletion criteria described above.","16 Years",{"count":392,"type":22},68,[114],"This open-label, single arm phase 1 trial aims to determine the safety and tolerability of anti-CD19 and anti-CD22 chimeric antigen receptor-expressing (CAR) T cells (CD19x22 CAR T) in adolescents and adults with relapsed\u002Frefractory (R\u002FR) B-cell Non-Hodgkin Lymphoma (B-NHL). This trial will determine the maximum tolerated dose of CD19x22 CAR T cells using a standard 3+3 trial design.",[396,397,30,398],"Non-Hodgkin Lymphoma","B-cell Non-Hodgkin Lymphoma (B-NHL)","CNS Lymphoma",[400,401],"Relapsed","Refractory","2025-12-17",{"date":404,"type":39},"2025-12-24",{"date":406,"type":39},"2021-12-21",{"date":408,"type":22},"2027-12",{"name":410,"class":285},"University of Colorado, Denver",{"id":412,"slug":413,"hasResults":12,"nctId":414,"briefTitle":415,"officialTitle":416,"acronym":417,"eligibilityCriteria":418,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":419,"targetDuration":4,"studyType":57,"phases":421,"briefSummary":422,"conditions":423,"keywords":424,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":253},"100614899","phase-2-clinical-trial-to-evaluate-the-efficacy-and-safety-of-pirtobrutinib-with-rituximab-in-patients-with-mantle-cell-lymphoma-100614899","NCT07285590","Clinical Trial to Evaluate the Efficacy and Safety of Pirtobrutinib With Rituximab in Patients With Mantle Cell Lymphoma","International Multicentric Phase II Trial to Evaluate the Efficacy and Safety of Pirtobrutinib in Combination With Rituximab in Patients With Indolent Clinical Forms of Mantle Cell Lymphoma","IMCL-2023","Inclusion Criteria:\n\n1. Adult patients (≥18 years of age).\n2. Written informed consent must be obtained before any study-specific assessment is performed.\n3. Subjects with confirmed diagnosis of Mantle Cell Lymphoma according to the International Consensus Classification, (ICC) 2022\\] or World Health Organization (WHO) Classification 2022. Classical, small-cell variants and marginal-zone variants can be included.\n4. Naïve patients for MCL management (no prior therapies, excluding diagnostic splenectomy)\n5. Asymptomatic patients\n6. Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C2 (0-1)\n7. Clinical stage I-IV according to the Ann Arbor classification with no symptoms attributable to MCL\n8. Patients with a leukemic non-nodal presentation with mainly bone marrow or peripheral blood involvement are eligible. Other asymptomatic clinical presentations are acceptable in case of low tumour burden, including MCL with lymph node enlargement ≤ 3 cm in the largest diameter and with low proliferation index (Ki67 \\\u003C 30%)\n9. The following laboratory values at screening:\n\n   * Neutrophil count ≥ 1×109\u002FL, Haemoglobin level ≥ 100 g\u002FL and platelet count ≥100×109\u002FL\n   * Transaminases (AST and ALT) ≤ 3 x ULN\n   * Total bilirubin ≤1.5 x ULN unless bilirubin rise is due to Gilbert's disease\n   * Calculated creatinine clearance ≥ 30 ml\u002Fmin according to Cockcroft\u002FGault Formula (140 - age) × body weight (kg) × 0.85 (if female)\u002F serum creatinine (mg\u002FdL) × 72\n   * Adequate coagulation, defined as activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) and prothrombin (PT) or (international normalized ratio (INR) not greater than 1.5 x ULN.\n10. Stable disease without evidence of clinical progression for at least 3 months. Patients in prolonged observation may be included (over 3 months).\n11. Female patients of child-bearing potential must have a negative serum pregnancy test at screening and agree to use highly effective contraception from the start of study treatment (See Appendix 4), during the treatment period and for at least 1 month following the last dose of pirtobrutinib and for 12 months following treatment with Rituximab.\n12. Male patients must use highly effective contraception (if sexually active with a female of child-bearing potential) according to the recommendations provided by the Clinical Trial Facilitation and Coordination Group (CTFG), from start of study treatment, during the treatment period, and for at least 1 month following the last dose of pirtobrutinib and for 12 months following treatment with rituximab.\n13. Willing and capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.\n14. Not included in other clinical trial or treated with an experimental drug unrelated to MCL within the past 2 years\n\nExclusion Criteria:\n\n1. Subjects with aggressive histological variants: blastoid and pleomorphic variants of MCL\n2. B-cell monoclonal lymphocytosis with MCL phenotype\n3. Presence of B symptoms or any relevant symptoms related to the MCL.\n4. Nodal clinical forms with lymph node enlargement \\> 3 cm (largest diameter).\n5. Organ dysfunction related to MCL including creatinine level \\> 2 mg\u002Fdl or altered liver biochemistry (\\> 3x ULN).\n6. Serum LDH over ULN\n7. Known central nervous system (CNS) infiltration.\n8. Expected MCL therapy requirement in a short time (\\\u003C 3 months)\n9. Anticoagulation requirement with vitamin K antagonists\n10. History of bleeding diathesis\n11. Past medical history of stroke or intracranial haemorrhage within 6 months prior to inclusion.\n12. Significant cardiovascular disease defined as: i) unstable angina or acute coronary syndrome within the past 2 months prior to randomization; ii) history of myocardial infarction within 3 months prior to randomization or documented LVEF by any method of ≤ 40% in the 12 months prior to inclusion; iii) ≥ Grade 3 NYHA functional classification system of heart failure; iv) Uncontrolled or symptomatic arrhythmias.\n13. Prolongation of the QT interval corrected for heart rate (QTcF) \\> 470 msec. QTcF is calculated using Fridericia's Formula (QTcF): QTcF = QT\u002F(RR0.33). Correction of suspected drug-induced QTcF prolongation can be attempted at the investigator's discretion and only if clinically safe to do so with either discontinuation of the offending drug or switch to another drug not known to be associated with QTcF prolongation. Correction for underlying bundle branch block (BBB) allowed.\n\n    NOTE: Patients with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker\n14. Patients who have tested positive for Human Immunodeficiency Virus (HIV) are excluded due to risk of opportunistic infections with both HIV and BTK inhibitors. For patients with unknown HIV status, HIV testing will be performed at Screening and result must be negative for enrolment.\n15. Known active hepatitis B virus (HBV) infection based on criteria below: Patients with positive hepatitis B surface antigen (HBsAg) are excluded. Patients with positive hepatitis B core antibody (anti-HBc) and negative HBsAg require a negative hepatitis B polymerase chain reaction (PCR) evaluation before inclusion. Patients who are HBV DNA PCR positive will be excluded. Prophylactic antiviral treatment will be required in the patients with positive anti-HBc finally eligible.\n16. Hepatitis C virus (HCV): positive hepatitis C antibody. If positive hepatitis C antibody result, patient will need to have a negative result for hepatitis C ribonucleic acid (RNA) before inclusion. Patients who are hepatitis C RNA positive will be excluded.\n17. Known active cytomegalovirus (CMV) infection. Unknown or negative status are eligible.\n18. Concomitant or previous malignancies the last 2 years other than basal skin cancer or in situ uterine cervix cancer.\n19. Major surgery within 4 weeks of inclusion.\n20. Vaccinated with live, attenuated vaccines within 4 weeks of inclusion.\n21. Active uncontrolled auto-immune cytopenia (e.g., autoimmune haemolytic anaemia \\[AIHA\\], idiopathic thrombocytopenic purpura \\[ITP\\]) for which new therapy was introduced or existing therapy was escalated within the 4 weeks prior to study enrolment to maintain adequate blood counts.\n22. Evidence of other clinically significant uncontrolled condition(s) including but not limited to, uncontrolled systemic bacterial, viral, fungal or parasitic infection (except for fungal nail infection), or any other clinically significant active disease process which in the opinion of the investigator may pose a risk for patient participation (screening for chronic conditions is not required).\n23. Known hypersensitivity to any of the excipients of Pirtobrutinib or Rituximab or any intended study medications.\n24. Females who are pregnant or breastfeeding or plan to become pregnant or initiate breastfeeding during the study or within 1 month of the last dose of pirtobrutinib or 12 months of the last dose of rituximab.\n25. Patients unable to take oral medication or with clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug.",{"count":420,"type":22},50,[59],"This is a multicenter, international, open-label, single-arm phase II clinical trial designed to evaluate the activity and safety of a combination therapy with pirtobrutinib and rituximab (P-R) in treatment-naïve adult patients diagnosed with indolent clinical forms of Mantle Cell Lymphoma (MCL). The study applies a Simon's two-stage design, with an interim analysis after the first 16 patients to determine continuation based on complete remission rate (CRR) after 6 cycles.",[30],[425,426,427,428,429,88],"lymphoma","Geltamo","Rituximab","Pirtobrutinib","Mantle cell lymphoma","2025-12-02",{"date":432,"type":39},"2025-12-16",{"date":434,"type":39},"2025-09-30",{"date":436,"type":22},"2032-12",{"name":438,"class":285},"Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea",{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":4,"eligibilityCriteria":445,"healthyVolunteers":12,"sex":18,"minAge":446,"maxAge":4,"enrollmentInfo":447,"targetDuration":4,"studyType":57,"phases":448,"briefSummary":449,"conditions":450,"keywords":451,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":454,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":460,"locationsCount":47},"100613892","phase-2-orelabrutinib-plus-lisaftoclax-and-rituximab-in-untreated-mantle-cell-lymphoma-with-high-risk-disease-100613892","NCT07272499","Orelabrutinib Plus Lisaftoclax and Rituximab in Untreated Mantle Cell Lymphoma With High-Risk Disease","A Prospective, Multicenter, Open-Label Clinical Study of Orelabrutinib Plus Lisaftoclax and Rituximab in Treatment-Naive, High-Risk Mantle Cell Lymphoma (MCL)","Inclusion Criteria:\n\n* Diagnosed with MCL (mantle cell lymphoma) through flow cytometry or histopathology, and has not received prior treatment.\n* Age \\> 14 years of age, both genders are eligible.\n* Ann Arbor stage II-IV; for stage II subjects, those who require systemic therapy based on the investigator's judgment are eligible.\n* At least one measurable lesion.\n* Any one of the following high-risk factors is present: MIPI score of 6-11, Ki67 \\> 30%, TP53 mutation\u002Floss or p53 protein expression \\>50%, blastic or pleomorphic variation.\n* Laboratory tests (blood routine, liver and kidney function) meet the following requirements: a) Blood routine: White blood cell count ≥3.0×10\\^9\u002FL, absolute neutrophil count ≥1.5×10\\^9\u002FL, hemoglobin ≥90g\u002FL, platelet count ≥75×10\\^9\u002FL. b) Liver function: Transaminases ≤2.5 times the upper limit of normal, bilirubin ≤1.5 times the upper limit of normal. c) Serum creatinine 44-133 mmol\u002FL.\n* The investigator judges that the subject's life expectancy is greater than 12 weeks from the time of screening.\n* Willing and able to participate in all required assessments and procedures of the study protocol.\n\nExclusion Criteria:\n\n* Patients who have previously received treatment with BTK inhibitors.\n* Patients with severe complications or serious infections.\n* Patients with uncontrolled cardiovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases, etc.\n* Patients with active infections requiring systemic treatment, including bacterial, fungal, and viral infections.\n* HIV-infected individuals.\n* Patients with mental disorders or those who are known or suspected to be unable to fully comply with the study protocol.\n* Patients whom the investigator judges to have other conditions that make them unsuitable for participation in this study.","14 Years",{"count":7,"type":22},[59],"This multicenter, open-label, trial aims to evaluate the efficacy and safety of orelabrutinib plus lisaftoclax and rituximab in patients with high-risk mantle cell lymphoma (MCL). The primary objective is to assess the optimal complete response (CR) rate during the induction phase, with secondary objectives including progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and safety. Exploratory analysis will investigate the correlation between tumor biomarkers and treatment efficacy.",[30],[452],"Order2","2025-11-26",{"date":455,"type":39},"2025-12-09",{"date":457,"type":39},"2025-09-10",{"date":459,"type":22},"2028-09-10",{"name":461,"class":285},"Ruijin Hospital",{"id":463,"slug":464,"hasResults":12,"nctId":465,"briefTitle":466,"officialTitle":467,"acronym":4,"eligibilityCriteria":468,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":361,"enrollmentInfo":469,"targetDuration":4,"studyType":57,"phases":470,"briefSummary":472,"conditions":473,"keywords":4,"overallStatus":191,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":480,"locationsCount":47},"100613308","phase-4-zsdt-for-the-treatment-of-rr-mantle-cell-lymphoma-after-btk-inhibitor-failure-a-multi-center-prospective-clinical-trial-100613308","NCT07264894","ZSDT for the Treatment of R\u002FR Mantle Cell Lymphoma After BTK Inhibitor Failure: a Multi-center Prospective Clinical Trial","ZSDT for the Treatment of Recurrent Refractory Mantle Cell Lymphoma After BTK Inhibitor Failure: a Multi-center Prospective Clinical Trial","Inclusion Criteria:\n\n1. Ages 18-70, ECOG score 0-2(including ages 18 and 70);\n2. Overall Survival \\> 6 months;\n3. The diagnosis of mantle cell lymphoma was confirmed by histopathology. 4.At least one measurable lesion;\n\n5.Acceptable hematologic parameters, no contraindications to chemotherapy, absolute neutrophil ≥1.0 × 10 \\^ 9 L, platelet ≥75 × 10 \\^ 9 L, hemoglobin ≥80 g\u002FL (except for patients with bone marrow infiltration) 6.Liver function: direct bilirubin ≤1.5 × upper limit , Alanine transaminase or aspartate transaminase ≤2.5 × upper limit , Alkaline phosphatase≤3 × ULN in patients without non-bone involvement 7.Renal function: serum creatinine ≤1.5 ×ULN 5; 8.Women of Childbearing Potential (WOBCP) or men and their WOBCP partners should agree to take effective contraceptive measures from the signing of ICF and WOBCP must undergo a serum pregnancy test within seven days before the first medication and the results are negative; 9.Recurrent refractory patients after BTK inhibitor treatment; 10.The subjects voluntarily participate the study.\n\nExclusion Criteria:\n\n1. Refusing to take blood samples;\n2. Previous allergies to any of the medications in the regimen;\n3. Pregnant and lactating women;\n4. The researchers believe that major diseases can cause interference in the trial.;\n5. Combined with other tumors.;\n6. There are drug-related contraindications to treatment in the protocol;\n7. People with severe mental illness;\n8. Participating in other clinical trials;\n9. Other serious diseases that may limit the subject's participation in this trial, such as: uncontrolled diabetes mellitus; Severe cardiac insufficiency (NYHA classification II or above); Acute coronary syndrome within the past 6 months; Coronary revascularization such as stenting, coronary artery bypass surgery, and other heart and large vessel related surgeries in the past 6 months; Severe arrhythmias include frequent premature ventricular episodes, ventricular tachycardia, rapid atrial fibrillation\u002Fatrial flutter, and severe bradycardia. Uncontrolled hypertension: systolic blood pressure \\> 150 mmHg, diastolic blood pressure \\> 100 mmHg. Gastric ulcer (gastric ulcer judged by the investigator to be at risk of perforation); Active autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjögren's syndrome, autoimmune thrombocytopenia, etc.); Severe respiratory diseases (such as obstructive pulmonary disease and history of bronchospasm), etc.;\n10. In the opinion of the investigators, it is not suitable for enrollment;\n11. Hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer test is not within the normal reference value; Those who are positive for hepatitis C virus (HCV) antibody and positive for hepatitis C virus (HCV) RNA in peripheral blood; Those who are positive for human immunodeficiency virus (HIV) antibodies; Those who test positive for syphilis.",{"count":363,"type":22},[471],"PHASE4","For relapsed\u002Frefractory mantle cell lymphoma patients that previously treated with BTK inhibitors: The first part involves 6 cycles of combined therapy with zuberitamab, selinexor, dexamethasone, and thalidomide. This targeted combination regimen can enhance efficacy while reducing toxic side effects. The second part utilizes Zuberitamab plus selinexor for maintenance consolidation therapy, thereby reducing relapse and prolonging survival.",[30],"2025-11-24",{"date":476,"type":39},"2025-12-04",{"date":478,"type":22},"2025-12-31",{"date":100,"type":22},{"name":481,"class":285},"Zhengzhou University",{"id":483,"slug":484,"hasResults":12,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":4,"eligibilityCriteria":488,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":261,"enrollmentInfo":489,"targetDuration":4,"studyType":57,"phases":491,"briefSummary":492,"conditions":493,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":496,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":47},"100612740","pomalidomide-plus-orelabrutinib-and-zuberitamab-in-untreated-mantle-cell-lymphoma-100612740","NCT07257510","Pomalidomide Plus Orelabrutinib and Zuberitamab in Untreated Mantle Cell Lymphoma","A Prospective, Multicenter Clinical Study of Pomalidomide Combined With Orelabrutinib and Zuberitamab in Treatment-Naive Mantle Cell Lymphoma","Inclusion Criteria:\n\n* Pathologically confirmed mantle cell lymphoma\n* Age 18-80 years, both genders are eligible..\n* Untreated MCL.\n* At least one measurable lesion. Measurable disease is defined as a tumor mass measurable in one or two dimensions ≥1.5 cm, as well as measurable spleen lesions.\n* Any one of the following factors is present:: MIPI intermediate-high risk, ki67≥30%, blastoid\u002Fpleomorphic, TP53 abnormality (mutation\u002Fdeletion) or p53 protein expression \\>50%, large mass (maximum diameter ≥7.5cm), complex karyotype (≥3 chromosomal abnormalities (excluding t(11; 14)))\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2.\n* Hematologic function is adequate, defined as:\n\n  1. Absolute neutrophil count (ANC) ≥1×109\u002FL, growth factor support must not be used within 7 days prior to testing;\n  2. Platelet count ≥75×10⁹\u002FL, or ≥50×10⁹\u002FL (if bone marrow involvement), no use of growth factor support or transfusion allowed within 7 days prior to testing.\n* Adequate hepatic function per local laboratory reference range as follow:\n\n  1. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5× the upper limit of normal (ULN);\n  2. Bilirubin ≤ 2 × ULN (except for those diagnosed with Gilbert's syndrome, which allows up to 5 × ULN)\n* Adequate renal function as demonstrated by:\n\n  1. Creatinine clearance ≥60 mL\u002Fmin (estimated using the Cockcroft-Gault formula or the glomerular filtration rate \\[eGFR\\] estimated using the Modification of Diet in Renal Disease \\[MDRD\\] formula)\n  2. Serum creatinine ≤1.5×ULN\n* International Normalized Ratio (INR) ≤ 1.5 × ULN and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN\n* Life expectancy of more than 3 months.\n* Ability to provide written informed consent and understand and comply with study requirements.\n* Able to comply with the study visit schedule and other protocol requirements\n\nExclusion Criteria:\n\n* Current central nervous system involvement or suspected patients and those with a history of this condition\n* Previously received systemic treatment for MCL, including BTKi.\n* Uncontrolled active systemic fungal, bacterial, or viral infections (defined as persistent signs\u002Fsymptoms related to the infection despite the use of appropriate antibiotics, antiviral therapy, and\u002For other treatments with no improvement).\n* Known human immunodeficiency virus (HIV) infection, or the following serological status indicating active hepatitis B or C virus infection:\n\n  1. Subjects with positive hepatitis B virus core antibody (HBcAb) and negative surface antigen (HBsAg) must have a negative polymerase chain reaction (PCR) result prior to the first dose. Subjects with positive HBsAg or HBV-DNA:\n  2. Subjects with positive hepatitis C antibodies must have an HCV-RNA negative result before the first dose. Subjects with positive hepatitis C PCR results will not be eligible for this study.\n* Clinically severe cardiovascular diseases, including:\n\n  1. Myocardial infarction occurring within the 6 months prior to screening;\n  2. Unstable angina occurring within 3 months prior to screening;\n  3. Clinically significant arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes ventricular tachycardia);\n  4. QTcF (corrected by Fridericia's formula) \\> 480 msec;\n  5. History of second-degree type II atrioventricular (AV) conduction block or third-degree atrioventricular conduction block;\n  6. III or IV congestive heart failure as defined by the New York Heart Association (NYHA)\n* History of severe hemorrhagic disorders, such as hemophilia A, hemophilia B, von Willebrand disease, or a history of spontaneous bleeding requiring blood transfusion or other medical interventions.\n* History of deep vein thrombosis (DVT) or pulmonary embolism (PE) in the past 12 months\n* History of significant cerebrovascular disease\u002Fevents within 6 months prior to the first administration of the investigational drug, including stroke or intracranial hemorrhage.\n* Unable to swallow capsules or having significant gastrointestinal functional disorders, such as malabsorption syndrome, gastric or small intestine resection, symptomatic inflammatory bowel disease, or partial or complete intestinal obstruction.\n* Continuous treatment with strong and moderate CYP3A inhibitors or CYP3A inducers is required. If the patient has taken strong or moderate CYP3A inhibitors or inducers within 7 days prior to the first dose of the investigational drug (or has taken these drugs for less than 5 half-lives), they cannot be enrolled. Patients using moderate CYP3A inhibitors can be considered for the study after at least a 7-day washout period.\n* Anticoagulation treatment with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon) is required within 7 days after the first dose of the investigational drug or receiving anticoagulation therapy.\n* Pregnant or breastfeeding women\n* Hypersensitivity to any investigational drug\n* Any mental or cognitive impairment that may limit their understanding, execution, and compliance with the informed consent form and the study.\n* Subjects with drug abuse and alcoholism",{"count":490,"type":22},34,[297],"This multicenter trial evaluates the efficacy and safety of pomalidomide combined with orelabrutinib and zuberitamab (POZ) in patients with mantle cell lymphoma (MCL). After six cycles of POZ, patients who achieved minimal residual disease (MRD) negativity received maintenance therapy with orelabrutinib plus zuberitamab for up to 18 cycles. Those with MRD positivity were excluded and received alternative treatments. The primary endpoint is the MRD rate after six cycles of POZ. Secondary endpoints include progression-free survival (PFS), overall survival (OS), MRD rate, objective response rate (ORR), and safety.",[30,494],"POZ","2025-11-20",{"date":430,"type":39},{"date":498,"type":39},"2025-08-01",{"date":500,"type":22},"2028-08-01",{"name":502,"class":285},"Peking University Third Hospital",{"id":504,"slug":505,"hasResults":12,"nctId":506,"briefTitle":507,"officialTitle":508,"acronym":4,"eligibilityCriteria":509,"healthyVolunteers":12,"sex":18,"minAge":446,"maxAge":4,"enrollmentInfo":510,"targetDuration":4,"studyType":57,"phases":512,"briefSummary":513,"conditions":514,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":521,"locationsCount":47},"100608264","phase-2-orelabrutinib-and-rituximab-with-optional-autologous-hematopoietic-stem-cell-transplantation-in-mcl-treatment-100608264","NCT07199296","Orelabrutinib and Rituximab With Optional Autologous Hematopoietic Stem Cell Transplantation in MCL Treatment","A Prospective, Multicenter, Open-Label Clinical Study of Orelabrutinib in Combination With Rituximab With Optional Autologous Hematopoietic Stem Cell Transplantation in Treatment-Naive, Non-High-Risk Mantle Cell Lymphoma (MCL)","Inclusion Criteria:\n\n* Diagnosed with MCL (mantle cell lymphoma) through flow cytometry or histopathology, and has not received prior treatment.\n* Age \\> 14 years of age, both genders are eligible.\n* Ann Arbor stage II-IV; for stage II subjects, those who require systemic therapy based on the investigator's judgment are eligible.\n* At least one measurable lesion.\n* Laboratory tests (blood routine, liver and kidney function) meet the following requirements: a) Blood routine: White blood cell count ≥3.0×10\\^9\u002FL, absolute neutrophil count ≥1.5×10\\^9\u002FL, hemoglobin ≥90g\u002FL, platelet count ≥75×10\\^9\u002FL. b) Liver function: Transaminases ≤2.5 times the upper limit of normal, bilirubin ≤1.5 times the upper limit of normal. c) Serum creatinine 44-133 mmol\u002FL.\n* The investigator judges that the subject's life expectancy is greater than 12 weeks from the time of screening.\n* Willing and able to participate in all required assessments and procedures of the study protocol.\n\nExclusion Criteria:\n\n* Patients who have previously received treatment with BTK inhibitors.\n* Any one of the following high-risk factors is present: MIPI score of 6-11, Ki67 \\> 30%, TP53 abnormality, blastic or pleomorphic variation.\n* Patients with severe complications or serious infections.\n* Patients with uncontrolled cardiovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases, etc.\n* Patients with active infections requiring systemic treatment, including bacterial, fungal, and viral infections.\n* HIV-infected individuals.\n* Patients with mental disorders or those who are known or suspected to be unable to fully comply with the study protocol.\n* Patients whom the investigator judges to have other conditions that make them unsuitable for participation in this study.",{"count":511,"type":22},45,[59],"This multicenter, open-label, trial aims to evaluate the efficacy and safety of orelabrutinib in combination with rituximab with optional autologous hematopoietic stem cell transplantation in patients with non-high-risk mantle cell lymphoma (MCL). The primary objective is to assess the optimal complete response (CR) rate during the induction phase, with secondary objectives including progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and safety. Exploratory analysis will investigate the correlation between tumor biomarkers and treatment efficacy.",[30],"2025-09-28",{"date":434,"type":39},{"date":518,"type":39},"2025-07-01",{"date":520,"type":22},"2028-07-01",{"name":461,"class":285},{"id":523,"slug":524,"hasResults":12,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":4,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":529,"targetDuration":4,"studyType":57,"phases":531,"briefSummary":532,"conditions":533,"keywords":535,"overallStatus":191,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":539,"startDateStruct":541,"completionDateStruct":542,"leadSponsor":544,"locationsCount":47},"100594799","phase-1-jwcar239-in-patients-with-b-cell-non-hodgkin-lymphoma-100594799","NCT07024147","JWCAR239 in Patients With B Cell Non-Hodgkin Lymphoma","An Open-Label, Single-arm Study of JWCAR239 in the Treatment of Relapse \u002F Refractory (R\u002FR) B Cell Non-Hodgkin Lymphoma (B-NHL)","Inclusion Criteria:\n\n1. Histologically confirmed B-NHL with immunohistochemical positivity for CD20 and\u002For CD19 (accepting previous pathological reports and\u002For pathological review results of previous or fresh tumor tissues). According to the 2022 World Health Organization (WHO) classification, the pathological types include:Diffuse large B-cell lymphoma, Follicular large B-cell lymphoma (FL3B),Large B-cell lymphoma transformed from indolent B-NHL, Follicular lymphoma (excluding in situ follicular lymphoma, pediatric-type follicular lymphoma, and duodenal-type follicular lymphoma),Marginal zone lymphoma Mantle cell lymphoma (excluding in situ mantle cell neoplasms and leukemic non-nodal mantle cell lymphoma)\n2. Relapsed or refractory disease after receiving two or more lines of adequate treatment, or failure after autologous hematopoietic stem cell transplantation (ASCT).\n3. CT-measurable lesions and PET-evaluable positive lesions as defined by the 2014 Lugano criteria (lymph node or extranodal lesions must have two measurable diameters; lymph node lesions must have a long diameter \\>1.5 cm, and extranodal lesions must have a long diameter \\>1 cm).\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n5. Adequate organ function:\n\n   Sufficient bone marrow function as assessed by the investigator (absolute neutrophil count ≥1,000\u002FμL after at least 72 hours off growth factors; platelet count ≥50,000\u002FμL without blood transfusion within 7 days; absolute lymphocyte count ≥100\u002FμL).\n\n   Serum creatinine ≤1.5× upper limit of normal (ULN) or creatinine clearance ≥50 mL\u002Fmin (calculated by the Cockcroft-Gault formula).\n\n   Alanine aminotransferase (ALT) ≤5×ULN and total bilirubin \\\u003C2×ULN (or \\\u003C3×ULN for subjects with Gilbert syndrome or hepatic involvement by lymphoma).\n\n   Pulmonary function: ≤ CTCAE Grade 1 dyspnea and SpO2 ≥92% in room air. Cardiac function: Left ventricular ejection fraction (LVEF) ≥50% as assessed by echocardiography.\n6. Adequate vascular access for leukapheresis.\n7. Expected survival \\>12 weeks.\n8. Non-abstinent female subjects of childbearing potential must agree to use a highly effective contraceptive method plus an additional barrier method from at least 28 days before lymphodepletion until 2 years after JWCAR239 infusion. Male subjects with fertile partners must agree to use effective contraception from at least 28 days before lymphodepletion until 2 years after JWCAR239 infusion and must not donate semen or sperm throughout the study.\n\nExclusion Criteria:\n\n1. Lymphoma involving the central nervous system (CNS).\n2. EBV-positive DLBCL or Richter transformation of chronic lymphocytic leukemia.\n3. History of other malignant tumors with complete remission for less than 2 years, or current presence of other malignant tumors (exceptions to the 2-year restriction include: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, treated localized prostate cancer, biopsy-confirmed cervical in situ carcinoma, or cervical smears showing squamous intraepithelial lesions, or completely resected tumors with low recurrence potential as assessed by the investigator).\n4. At screening, the subject has:\n\n   Active hepatitis B or C (subjects with HBV DNA or HCV RNA below the lower limit of the central reference value by PCR may be enrolled). For occult or prior HBV-infected subjects, prophylactic antiviral therapy and regular monitoring of HBV-DNA are required.\n\n   Human immunodeficiency virus (HIV) infection or syphilis infection.\n5. Acute deep vein thrombosis (DVT) (tumor thrombus or thrombus) or pulmonary embolism (PE) within 3 months prior to informed consent signing.\n6. Receiving anticoagulant therapy for acute DVT or PE within 3 months prior to informed consent signing (prophylactic treatment ).\n7. Uncontrolled systemic fungal, bacterial, viral, or other infections.\n8. Acute or chronic graft-versus-host disease (GvHD).\n9. History of any of the following cardiovascular diseases within the past 6 months: New York Heart Association (NYHA) Class III or IV heart failure, coronary angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant heart diseases.\n10. Clinically significant CNS disease or symptoms at screening or within the past 6 months, such as epilepsy, seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychiatric disorders.\n11. Pregnant or lactating women. Females of childbearing potential must have a negative serum pregnancy test within 48 hours before starting lymphodepletion chemotherapy.\n12. Use of any of the following drugs or treatments within the specified time before leukapheresis:\n\n    Alemtuzumab within 6 months before leukapheresis. Bendamustine within 6 months before leukapheresis. Cladribine within 3 months before leukapheresis. Fludarabine within 3 months before leukapheresis. Anti-CD20 monoclonal antibodies within 7 days before leukapheresis. Venetoclax within 4 days before leukapheresis. Idelalisib within 2 days before leukapheresis. Lenalidomide within 1 day before leukapheresis. Pharmacological doses of corticosteroids (defined as prednisone \\>5 mg\u002Fday or equivalent) within 7 days before leukapheresis or within 72 hours before JWCAR239 injection. Physiological replacement, topical, and inhaled steroids are permitted.\n\n    Chemotherapy (e.g., vincristine, rituximab, cyclophosphamide) required to control the disease after leukapheresis must have been discontinued ≥7 days before lymphodepletion chemotherapy.\n\n    Administration of non-lymphocyte-toxic cytotoxic chemotherapy within 1 week before leukapheresis. Enrollment is permitted if the oral chemotherapy has undergone at least 3 half-lives before leukapheresis.\n\n    Receipt of lymphocyte-toxic chemotherapy (e.g., cyclophosphamide, ifosfamide, chlorambucil, or melphalan) within 2 weeks before leukapheresis.\n\n    Use of investigational drugs within 4 weeks before leukapheresis. However, enrollment is permitted if the investigational treatment was ineffective or caused disease progression, and at least 3 half-lives have elapsed before leukapheresis.\n\n    Treatment with immunosuppressive agents (e.g., calcineurin inhibitors, methotrexate or other chemotherapeutic drugs, mycophenolate, rapamycin, thalidomide, immunosuppressive antibodies such as anti-TNF, anti-IL-6, or anti-IL-6R) within 4 weeks before leukapheresis and JWCAR239 injection.\n\n    Receipt of donor lymphocyte infusion (DLI) within 6 weeks before JWCAR239 injection.\n\n    Radiation therapy involving large bone marrow areas (e.g., sternum or pelvis) within 6 weeks before leukapheresis. Subjects are eligible only if the disease progresses at the radiation site or PET-positive lesions exist in non-irradiated areas. If PET-positive lesions exist in non-irradiated areas, radiation therapy to a single lesion is permitted within 2 weeks before leukapheresis.\n13. Any other significant disease, abnormality, or condition that, in the investigator's judgment, renders the subject unsuitable for participation in the study or places the subject at risk. Any factors affecting compliance with the protocol, including uncontrollable medical, psychological, family, sociological, or geographical factors; or unwillingness or inability to adhere to the procedures required by the study protocol.\n14. Prior allogeneic hematopoietic stem cell transplantation.\n15. Prior treatment with CAR+ T cells or other genetically modified T cells.",{"count":530,"type":22},20,[114],"JWCAR239 is a CD19\u002FCD20 CAR-T product. This trial is intended to evaluate the safety, PK\u002FPD and efficacy of JWCAR239 in patients with B Cell Non-Hodgkin Lymphoma (B-NHL)",[73,367,268,534,30],"Marginal Zone B Cell Lymphoma",[273,536,537],"dual target","B-NHL","2025-06-08",{"date":540,"type":39},"2025-06-17",{"date":518,"type":22},{"date":543,"type":22},"2030-07-01",{"name":545,"class":285},"Peking University Cancer Hospital & Institute",{"id":547,"slug":548,"hasResults":12,"nctId":549,"briefTitle":550,"officialTitle":551,"acronym":4,"eligibilityCriteria":552,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":553,"targetDuration":4,"studyType":57,"phases":554,"briefSummary":555,"conditions":556,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":558,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":564,"locationsCount":47},"100581144","phase-2-acalabrutinib-plus-rituximab-for-the-treatment-of-elderly-or-low--to-intermediate-risk-younger-untreated-mantle-cell-lymphoma-100581144","NCT06846489","Acalabrutinib Plus Rituximab for the Treatment of Elderly or Low- to Intermediate-Risk Younger Untreated Mantle Cell Lymphoma","Acalabrutinib Plus Rituximab for the Treatment of Elderly or Low- to Intermediate-Risk Younger Untreated Mantle Cell Lymphoma: A Single-Arm, Open-Label, Multicenter, Phase II Study","Key inclusion Criteria:\n\n1. Age ≥18 years.\n2. Histologically confirmed CD20+ mantle cell lymphoma.\n3. No prior anti-lymphoma treatment.\n4. Ann Arbor stage II-IV.\n5. ECOG performance status 0-2, no deterioration \\>2 weeks before baseline or first dose.\n6. Younger subjects (\\\u003C65) must meet:\n\n   1. Low to intermediate risk sMIPI (0-5)\n   2. Ki67 \\\u003C 50%\n   3. No TP53 mutation (NGS)\n   4. Lesion diameter ≤5 cm\n   5. Non-blastoid, polymorphic disease\n7. At least one assessable lesion per Lugano 2014 criteria.\n8. Adequate organ and bone marrow function during screening.\n9. Female subjects must use contraception as per local regulations.\n10. Male subjects must agree to avoid sperm donation during the study and for 12 months post-rituximab.\n11. Willing to undergo all required assessments and procedures, including swallowing capsules\u002Ftablets.\n12. Able to understand the study's purpose and risks, and provide signed informed consent with authorization for the use of personal health information.\n\nKey exclusion Criteria:\n\n1. Participants with tumor burden reduction prior to stem cell transplantation.\n2. History of active lymphoma central nervous system (CNS) involvement, leptomeningeal disease, or spinal cord compression.\n3. Any disease evidence deemed by the investigator to be detrimental to the patient's participation or likely to affect protocol adherence (e.g., severe or uncontrolled systemic disease, including uncontrolled hypertension or kidney transplant).\n4. History of progressive multifocal leukoencephalopathy (PML) or current diagnosis of PML.\n5. Received any investigational drug within 30 days (or 5 half-lives, whichever is shorter) prior to the first dose of the investigational drug.\n6. Underwent major surgery within 30 days prior to the first dose of the investigational drug. Note: If the participant has undergone major surgery, they must be fully recovered from any toxicity and\u002For complications related to the surgery before the first dose.\n7. A history of malignancy that could affect protocol adherence or interpretation of results, except for: a. Basal cell carcinoma, squamous cell carcinoma of the skin, cervical carcinoma in situ, or prostate carcinoma in situ treated curatively at any time before the study. b. Other cancers that were treated surgically and\u002For with radiation, with no disease for ≥3 years without further treatment.\n8. Significant cardiovascular disease, such as symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months before screening, or any NYHA Class 3 or 4 heart disease during screening. Note:Participants with well-controlled, asymptomatic atrial fibrillation are allowed.\n9. Refractory nausea and vomiting, difficulty swallowing formulations, or malabsorption syndrome; chronic gastrointestinal disease, gastric bypass, or weight-loss surgery (e.g., Roux-en-Y); partial or complete bowel obstruction, or previous major intestinal surgery that may interfere with the absorption, distribution, metabolism, or elimination of the investigational drug.\n10. Received a live-virus vaccine within 28 days prior to the first dose of the investigational drug.\n11. Known HIV infection.\n12. Any active major infection (e.g., bacterial, viral, or fungal, including subjects with positive CMV DNA PCR).\n13. Serologic evidence of active hepatitis B or C infection.\n14. History of stroke or intracranial hemorrhage within 6 months prior to the first dose of the investigational drug.\n15. History of bleeding disorders (e.g., hemophilia, Von Willebrand disease).\n16. Requires or is receiving anticoagulation therapy with warfarin or equivalent vitamin K antagonists.\n17. Requires strong CYP3A inhibitors or inducers. The use of strong CYP3A inhibitors within 1 week or strong CYP3A inducers within 3 weeks before the first dose of the investigational drug is prohibited.\n18. Pregnancy or breastfeeding.\n19. Participation in another therapeutic clinical trial.\n20. Requires proton pump inhibitor therapy (e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole).\n21. Currently has a life-threatening disease, medical condition, or organ system dysfunction that, in the investigator's judgment, may compromise the participant's safety or place the study at risk.",{"count":420,"type":22},[59],"This is a single- arm, open-label, multicenter, phase II study to evaluate Acalabrutinib plus Rituximab for the treatment of elderly or low- to intermediate-risk younger untreated mantle cell lymphoma",[30],"2025-05-28",{"date":559,"type":39},"2025-06-03",{"date":561,"type":39},"2025-04-14",{"date":563,"type":22},"2033-02-20",{"name":381,"class":285},{"id":566,"slug":4,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":567,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":568,"targetDuration":4,"studyType":57,"phases":569,"briefSummary":570,"conditions":571,"keywords":572,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":573,"lastUpdatePostDateStruct":574,"startDateStruct":576,"completionDateStruct":577,"leadSponsor":578,"locationsCount":7},"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":235,"type":22},[59],"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.",[62,63,64,65,66,67,30,68],[71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93],"2025-04-21",{"date":575,"type":39},"2025-04-24",{"date":98,"type":39},{"date":100,"type":22},{"name":102,"class":46},{"id":580,"slug":581,"hasResults":12,"nctId":582,"briefTitle":583,"officialTitle":584,"acronym":4,"eligibilityCriteria":585,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":586,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":588,"conditions":589,"keywords":590,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":592,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":598,"locationsCount":47},"100576696","a-study-of-patients-with-relapsedrefractory-mantle-cell-lymphoma-treated-with-lisocabtagene-maraleucel-in-the-post-marketing-setting-100576696","NCT06788652","A Study of Patients With Relapsed\u002FRefractory Mantle Cell Lymphoma Treated With Lisocabtagene Maraleucel in the Post-Marketing Setting","Non-interventional Cohort Study of Patients Treated With Lisocabtagene Maraleucel (Liso-cel) for Relapsed\u002FRefractory Mantle Cell Lymphoma in the Post-Marketing Setting","Inclusion Criteria:\n\n• Participants must have been treated in the postmarketing setting with at least 1 infusion of lisocabtagene maraleucel (Liso-cel) used for the treatment of Mantle Cell Lymphoma (MCL) according to the FDA-approved indication and dose range (ie, per the US Prescribing Information) and with a product meeting the specifications for commercial release approved in the USA\n\nExclusion Criteria:\n\n* Participants known to be participating in investigational studies at the time of liso-cel infusion.\n* Participants treated with non-conforming CAR T-cell product.",{"count":587,"type":22},300,"The purpose of this study is to understand the long-term safety and effectiveness of lisocabtagene maraleucel (liso-cel) for the treatment of Mantle Cell Lymphoma (MCL).",[30],[30],"2025-02-21",{"date":593,"type":39},"2025-02-24",{"date":595,"type":39},"2025-02-04",{"date":597,"type":22},"2044-09-30",{"name":599,"class":46},"Juno Therapeutics, Inc., a Bristol-Myers Squibb Company",{"id":601,"slug":602,"hasResults":12,"nctId":603,"briefTitle":604,"officialTitle":605,"acronym":606,"eligibilityCriteria":607,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":608,"enrollmentInfo":609,"targetDuration":4,"studyType":57,"phases":610,"briefSummary":611,"conditions":612,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":595,"lastUpdatePostDateStruct":614,"startDateStruct":616,"completionDateStruct":618,"leadSponsor":620,"locationsCount":47},"100551805","phase-1-sequential-treatment-of-cd19-carnk-and-7x19-car-t-in-rr-b-cell-lymphoma-100551805","NCT06464861","Sequential Treatment of CD19 CARNK and 7x19 CAR-T in R\u002FR B Cell Lymphoma","Sequential Treatment With 7x19 CAR-T After Umbilical Cord Blood Derived CD19 CARNK in Relapsed\u002FRefractory B Cell Lymphoma","CD19-CARNK\u002FT","Inclusion Criteria:\n\n1. Age 18-75 years old, no gender limit;\n2. Histologically diagnosed as diffuse large B-cell lymphoma (DLBCL), transforming follicular lymphoma (TFL), primary mediastinal B-cell lymphoma (PMBCL), mantle cell lymphoma (MCL) and other inert B-cells NHL conversion type:\n\n   1. Refractory or relapsed DLBCL refers to the failure to achieve complete remission after 2-line treatment; disease progression during any treatment, or disease stable time equal to or less than 6 months; or disease progression or recurrence within 12 months after autologous hematopoietic stem cell transplantation ；\n   2. Refractory or relapsed MCL must be resistant to or intolerable to BTK inhibitors;\n   3. Refractory or relapsed indolent B-cell NHL is the failure or recurrence of third-line treatment;\n3. Previous treatment must include CD20 monoclonal antibody treatment (unless the subject is CD20 negative) and anthracyclines;\n4. At least one measurable lesion with the longest diameter ≥ 1.5 cm exists;\n5. The expected survival period is ≥12 weeks;\n6. The puncture section of the tumor tissue was positive for CD19 expression;\n7. ECOG score 0-2 points;\n8. Sufficient organ function reserve:\n\n   1. Alanine aminotransferase, aspartate aminotransferase ≤ 2.5× UNL (upper limit of normal value);\n   2. Creatinine clearance rate (Cockcroft-Gault method) ≥60 mL\u002Fmin;\n   3. Serum total bilirubin and alkaline phosphatase ≤1.5× UNL;\n   4. Glomerular filtration rate\\>50Ml\u002Fmin\n   5. Cardiac ejection fraction (EF) ≥50%;\n   6. Under natural indoor air environment, basic oxygen saturation\\>92%\n9. Allow a previous stem cell transplantation\n10. The approved anti-B-cell lymphoma treatments, such as systemic chemotherapy, systemic radiotherapy, and immunotherapy, have been completed for at least 3 weeks before the study medication;\n11. Allow patients who have previously received CAR-T cell therapy and have failed or relapsed after 3 months of evaluation;\n12. Female subjects of childbearing age must have a negative pregnancy test and agree to take effective contraceptive measures during the trial\n13. Two tests for the new coronavirus or swine flu virus are negative.\n\nExclusion Criteria:\n\n1. Allergic to any of the components of cell products;\n2. History of other tumors;\n3. Acute GvHD or extensive chronic GvHD with grade II-IV (Glucksberg standard) in the past or are receiving anti-GVHD treatment;\n4. Had received gene therapy within the past 3 months;\n5. Active infections requiring treatment (except for simple urinary tract infections, bacterial pharyngitis); however, prophylactic antibiotics, antiviral and antifungal infection treatment are permitted;\n6. Patents infected with hepatitis B (HBsAg positive, but HBV-DNA \\< 103 is not excluded) or hepatitis C virus (including virus carriers), syphilis and other acquired and congenital immunodeficiency diseases, including but not limited to HIV-infected persons;\n7. Subjects with Grade III or IV cardiac dysfunction according to the New York Heart Association\\'s cardiac function grading criteria;\n8. Patients who received antitumor therapy earlier but did not recover from the toxicity (CTCAE 5.0 toxicity did not recover to ≤ grade 1, except fatigue, anorexia, alopecia);\n9. Subjects with a history of epilepsy or other central nervous system disorders;\n10. Head-enhanced CT or MRI showing evidence of central nervous system lymphoma;\n11. Lactating women who are unwilling to stop breastfeeding;\n12. Any other factors that the investigator believes may increase the risk to the subject or interfere with the test results.","75 Years",{"count":210,"type":22},[114],"To study the safety and efficacy of cord blood-derived CD19 CAR-NK cells sequential with 7x19 CAR-T in relapse \u002F refractory B cell lymphoma",[65,30,613],"Diffuse Large B Cell Lymphoma( DLBCL)",{"date":615,"type":39},"2025-02-07",{"date":617,"type":39},"2024-06-20",{"date":619,"type":22},"2027-06-30",{"name":621,"class":285},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":623,"slug":624,"hasResults":12,"nctId":625,"briefTitle":626,"officialTitle":627,"acronym":628,"eligibilityCriteria":629,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":630,"enrollmentInfo":631,"targetDuration":4,"studyType":57,"phases":633,"briefSummary":634,"conditions":635,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":638,"lastUpdatePostDateStruct":639,"startDateStruct":641,"completionDateStruct":643,"leadSponsor":645,"locationsCount":647},"100561667","phase-1-car-t-cells-in-the-treatment-of-refractory-and-relapsed-cd19-b-cell-neoplasms-100561667","NCT06593145","CAR T Cells in the Treatment of Refractory and Relapsed CD19+ B Cell Neoplasms","Application of the Autologous CAR T Cells (Tarcidomgen Kimleucel) in the Treatment of Refractory and Relapsed CD19+ B Cell Neoplasms","CARLA","Inclusion Criteria:\n\n1. Adult patients 18-65 both inclusive;\n2. Diagnosis of:\n\n   1. Refractory B-ALL (acute lymphocytic leukemia) - relapse after hematopoietic cell transplantation, second or more relapse in patients when transplantation is contraindicated)\n   2. Large B-cell lymphoma including DLBCL NOS, lymphoma with high level of malignancy, follicular lymphoma transformed to DLBCL and primary mediastinal lymphoma - refractory or relapse or after at least 2 lines of systemic treatment)\n   3. Mantle cell lymphoma (MCL) - relapsing or refractory after at least 2 lines of systemic treatment; Diagnostics of individual diagnoses (criteria for complete remission and partial responses for individual disease entities) was developed on the basis of current (July 2022) recommendations of experts of the Polish Society of Clinical Oncology\n3. Confirmed CD19 expression on malignant cells;\n4. General condition measured by ECOG (Eastern Cooperative Oncology Group) ≤ 1;\n5. Patient's weight between 40 kg - 130 kg\n6. Sufficient general condition of organs on screening visit:\n\n   1. ALT\u002FAST \\\u003C2,5 of UNL and bilirubin \\\u003C1,5 mg\u002Fdl (\\\u003C4 mg\u002Fdl for patients with Gilbert syndrome)\n   2. Ejection fraction (EF) \\>50% confirmed in ECHO with no signs of exudation in pericardium during 6 weeks before screening\n   3. Saturation of arterial blood \\>93% with no oxygen insufflation, with no significant exudation in pleural cavity\n   4. Serum creatinine clearance \\>60 ml\u002Fmin (by Cockcroft-Gault formula);\n7. Negative result for HCV, HBV, HIV, Syphilis;\n8. Negative test for pregnancy (serum or urine) in the screening visit and\u002For 7 days before leucapheresis and 7 days before lymphodepleting therapy in women in reproductive age;\n9. Assumption of at least 12 months of survival time from screening visit;\n10. Agreement to maintain sufficient method of contraception from the date of signing informed consent to 6 months after CART therapy;\n11. The last dose of SARS-CoV-2 vaccination taken at least 6 months prior to study enrollment\n12. Capable of providing written informed consent;\n13. Patients polish native language speaking or fluent in polish language\n\nExclusion Criteria:\n\n1. Any significant CNS diseases that preceded and not connected with relapse (including seizures, paresis, aphasia, stroke or CNS bleeding, severe brain trauma, dementia, Parkinson's disease, any disease affecting cerebellum, psychosis and diseases involving lack of coordination or movement);\n2. Bulky or rapidly progressing disease;\n3. Less than 3 months after allo-HSCT transplantation or DLI before screening;\n4. The need for high-dose chemotherapy less than 4 weeks before the scheduled apheresis;\n5. Concomitant presence of another malignancy and another malignancy diagnosed up to 2 years before inclusion to this trial;\n6. Patient's weight below 40 kg and above 130kg\n7. Any active bacterial, viral or fungal infection including SARS-CoV2;\n8. Latent HBV\u002FHCV\u002FHIV\u002FSyphilis infection;\n9. Any other concomitant disease which in the opinion of the investigator would be interfering with the safety of participant in the trial\n10. Allergic to penicillin, streptomycin and amphotericin B;\n11. Intolerance to cyclophosphamide or fludarabine during previous treatment with these drugs;\n12. Chronic systemic immunosuppression treatment (i.e. cyclosporin). Corticosteroids are allowed up to dexamethasone dose of 4 mg a day or equal of this dose;\n13. Systemic immunosuppression treatment of acute and\u002For chronic Graft-versus host disease (GvHD) connected to earlier allogeneic HSCT treatment;\n14. Pregnancy;\n15. Women in reproductive age as well as men (regardless of age) that do not agree to maintain effective method of contraception during the trial, lactated women can be included into the trial unless declaration of stopping breast feeding during the whole trial time;\n16. Unable to provide informed consent for this trial;\n17. Lack of actual vaccination against SARS-CoV2 by vaccine accepted to use in the EU;\n18. Patients who are not fluent in polish language;\n19. Previous use of anti-CD19 CART therapy","65 Years",{"count":632,"type":22},6,[114],"One arm, open label study to assess the clinical use of Investigational Medicinal Product FCTX-CL19-1 (scientific name: Tarcidomgen Kimleucel) containing autologous anti-CD19 CAR T cells with a preliminary determination of the safety of intravenous IMP administration in patients diagnosed with refractory and relapsed CD19 + B cell neoplasms.",[636,30,637],"Acute Lymphoblastic Leukemia (ALL)","Large B-cell Lymphoma","2024-09-12",{"date":640,"type":39},"2024-09-19",{"date":642,"type":39},"2023-05-24",{"date":644,"type":22},"2025-06",{"name":646,"class":46},"FamiCordTx",2,{"id":649,"slug":650,"hasResults":12,"nctId":651,"briefTitle":652,"officialTitle":653,"acronym":4,"eligibilityCriteria":654,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":261,"enrollmentInfo":655,"targetDuration":4,"studyType":57,"phases":657,"briefSummary":659,"conditions":660,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":661,"lastUpdatePostDateStruct":662,"startDateStruct":664,"completionDateStruct":666,"leadSponsor":668,"locationsCount":47},"100554224","phase-3-bendamustine-and-rituximab-with-or-without-orelabrutinib-in-mcl-treatment-100554224","NCT06496308","Bendamustine and Rituximab With or Without Orelabrutinib in MCL Treatment","A Multicenter, Open-label, Randomized Controlled Study of Orelabrutinib in Combination With Bendamustine and Rituximab Versus Bendamustine and Rituximab in the Treatment of Transplant-Ineligible, Intermediate- to High-Risk Mantle Cell Lymphoma (MCL)","Inclusion Criteria:\n\n* Diagnosed with MCL (mantle cell lymphoma) through flow cytometry or histopathology, and has not received prior treatment.\n* Age \\> 18 years of age, both genders are eligible.\n* Ann Arbor stage II-IV; for stage II subjects, those who require systemic therapy based on the investigator's judgment are eligible.\n* At least one measurable lesion.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.\n* Any one of the following high-risk factors is present: MIPI score of 4-11, Ki67 \\> 50%, TP53 abnormality, blastic or pleomorphic variation.\n* Patients who are not suitable candidates for autologous hematopoietic stem cell transplantation.\n* Laboratory tests (blood routine, liver and kidney function) meet the following requirements: a) Blood routine: White blood cell count ≥3.0×10\\^9\u002FL, absolute neutrophil count ≥1.5×10\\^9\u002FL, hemoglobin ≥90g\u002FL, platelet count ≥75×10\\^9\u002FL. b) Liver function: Transaminases ≤2.5 times the upper limit of normal, bilirubin ≤1.5 times the upper limit of normal. c) Serum creatinine 44-133 mmol\u002FL.\n* The investigator judges that the subject's life expectancy is greater than 12 weeks from the time of screening.\n* Willing and able to participate in all required assessments and procedures of the study protocol.\n\nExclusion Criteria:\n\n* Patients who have previously received treatment with BTK inhibitors.\n* Patients with severe complications or serious infections.\n* Patients with uncontrolled cardiovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases, etc.\n* Patients with active infections requiring systemic treatment, including bacterial, fungal, and viral infections.\n* HIV-infected individuals.\n* Patients with mental disorders or those who are known or suspected to be unable to fully comply with the study protocol.\n* Patients whom the investigator judges to have other conditions that make them unsuitable for participation in this study.",{"count":656,"type":22},78,[658],"PHASE3","This multicenter, open-label, randomized controlled trial aims to evaluate the efficacy and safety of Orelabrutinib in combination with Bendamustine and Rituximab (OBR) versus Bendamustine and Rituximab (BR) in patients with intermediate- to high-risk mantle cell lymphoma (MCL) who are ineligible for transplantation. The primary objective is to assess the complete response (CR) rate during the induction phase, with secondary objectives including progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and safety. Exploratory analysis will investigate the correlation between tumor biomarkers and treatment efficacy.",[30],"2024-07-03",{"date":663,"type":39},"2024-07-11",{"date":665,"type":22},"2024-07-10",{"date":667,"type":22},"2027-07-10",{"name":461,"class":285}]