[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Miltenyi Biomedicine GmbH\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":395},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,73,109,146,169,194,220,241,263,287,315,334,357,373],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":35,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"100054189","phase-2-daly-ii-usa-mb-cart20191-for-dlbcl-100054189",false,"NCT04792489","DALY II USA\u002F MB-CART2019.1 for DLBCL","A Multi-center Single Arm Phase II Study to Evaluate the Safety and Efficacy of Genetically Engineered Autologous Cells Expressing Anti-CD20 and Anti-CD19 Specific Chimeric Antigen Receptor in Subjects With Relapsed and\u002For Refractory Diffuse Large B Cell Lymphoma","Inclusion Criteria:\n\n* Histologically confirmed B-cell non-Hodgkin's lymphoma:\n\n  * DLBCL cohort (both cohorts)\n* DLBCL or associated subtype, defined by WHO 2016 classification\n* DLBCL not otherwise specified (NOS)\n* High-grade B cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements\n* High-grade B cell lymphoma (NOS)\n* Primary mediastinal (thymic) large B cell lymphoma\n* Transformed lymphoma (e.g., transformed follicular, or marginal zone lymphoma, follicular lymphoma (FL Grade 3)\n\n  o CNS cohort\n* B-cell primary or secondary central nervous system lymphoma (PCNSL or SCNSL)\n\n  o Mantle Cell Lymphoma (MCL) cohort\n* Histologically confirmed MCL determined by overexpression of cyclin D1 or presence of t(11;14) (q13; q32) translocation\n\n  o Richter's Transformation (RT) cohort\n* Histologically confirmed RT to a diffuse large B-cell lymphoma (DLBCL) subtype from underlying CLL (clonally related)\n* Relapsed or refractory disease is defined for DLBCL (and associated subtypes) population as:\n\nFor DLBCL cohort (after receiving at least two prior lines of therapy): persistent disease after failure of 2 or more lines of chemotherapy including rituximab or equivalent and anthracycline and either after failed ASCT, or ineligible, not intended for or not consenting to ASCT\n\n* Chemotherapy-refractory disease (applies to all cohorts) is defined as persistent disease after last line of therapy or relapsed or persistent disease after prior ASCT for lymphoma\n* Disease relapse in subjects without prior ASCT is defined as relapse of disease after the last dose of most recent therapy regimen\n\nFor disease specific cohorts added after the initial DLBCL cohort the definition of relapsed\u002Frefractory disease is as described below:\n\nCNS cohort: Subjects with relapsed\u002Frefractory PCNSL that have failed (or unable to tolerate) at least first-line therapy.\n\n* First-line therapy is defined as either high dose methotrexatebased therapy, temozolomide, high dose cytarabine, pemetrexed, lenalidomide or Bruton tyrosine kinase (BTK) inhibitor-based therapy.\n* No contraindications for MRI evaluation\n* CNS cohort: Subjects with SCNSL must have relapsed or refractory disease after having received at least one prior line of systemic therapy\n* Prior lines of systemic therapy should include an anti-CD20 monoclonal antibody and anthracycline containing chemotherapy regimen and\u002For with or without an autologous stem cell transplant\n\nMCL cohort: Subjects with relapsed\u002Frefractory disease after at least one prior systemic treatment, that must include:\n\n* Cytotoxic rituximab \\[or equivalent\\] based chemotherapy regimen (eg, rituximab bendamustine, R-CHOP, R-DHAP, R-ARA-C) AND\n* BTK inhibitor\n\nRT cohort: Subject must have relapsed\u002Frefractory disease after at least one prior systemic treatment following Richter's Transformation\n\nDLBCL transplant ineligible 2nd cohort: subject must have failure of first-line chemotherapy (including rituximab or equivalent and anthracycline).\n\n* For this cohort subjects are considered transplant ineligible if they meet one of the following criteria:\n* Age ≥70 years\n* ECOG status is 2 at screening\n* Impaired pulmonary function: diffusing capacity of the lung for carbon monoxide \\[DLCO\\] ≤ 60% adjusted for gender-specific hemoglobin concentration (Coates formula)\n* Impaired cardiac function: left ventricular ejection fraction (LVEF) \\\u003C 50%; must be assessed by echocardiogram or multiple uptake gated acquisition (MUGA) scan performed within 4 weeks of determination of eligibility\n* Impaired renal function: calculated creatinine clearance (Cockcroft and Gault) \\\u003C 60 mL\u002Fmin\n* Impaired hepatic function: aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) \\> 2 x upper limit of normal (ULN)\n\nIn addition, all subjects must have:\n\n* Age ≥18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status that is either 0 or 1 at screening. ECOG performance status of 2 at screen is allowed if the decrease in performance status is due to lymphoma\n\n  * Subjects in DLBCL transplant-ineligible 2nd-line cohort with ECOG performance status of 2, regardless of attribution, will be allowed for inclusion\n* Measurable disease will be assessed by FDG-PET\u002FCT in systemic lymphoma . and by brain\u002Fspine MRI for CNS disease\n* Subject must have a tumor biopsy sample (at least 16 unstained slides of tissue or tissue block) from the most recent relapse available prior to MB-CART2019.1 infusion. If medically not feasible to obtain a biopsy from the most recent relapse and for cases when the amount of tissue is limited, the sponsor should be consulted, to confirm adequacy of the sample for study required analyses\n* No clinical suspicion of central nervous system (CNS) lymphoma (not applicable to CNS cohort)\n\n  * Subjects in DLBCL transplant-ineligible 2nd-line cohort with SCNSL will be allowed for inclusion\n* If the subject has history of CNS disease (not applicable to CNS cohort), then he\u002Fshe must have no signs or symptoms of CNS disease, have no active disease on magnetic resonance imaging (MRI), have no large cell lymphoma present in cerebral spinal fluid (CSF), regardless of the number of white blood cells (WBCs)\n* If has history of cerebral vascular accident (CVA), the CVA event must be greater than 12 months prior to leukapheresis. Any neurological deficits must be stable\n* A creatinine clearance (as estimated by direct urine collection or Cockcroft-Gault Equation) \\> 45mL\u002Fmin\n* Cardiac ejection fraction (EF) ≥ 45% as determined by an echocardiogram (ECHO) or Multigated Radionuclide Angiography (MUGA)\n* Subjects in DLBCL transplant-ineligible 2nd-line cohort with a lower ejection fraction of \\> 40% will be allowed for inclusion\n* Resting O2 saturation \\>90% on room air\n* Serum alanine aminotransferase (ALT) \u002F aspartate aminotransferase (AST)\\\u003C5 times the Upper Limit of Normal (ULN) for age\n* Total bilirubin \\\u003C1.5 mg\u002Fdl, except in individuals with Gilbert's syndrome\n* Subjects in DLBCL transplant-ineligible 2nd-line cohort with a total bilirubin of \\\u003C 2.0 mg\u002FdL will be allowed for inclusion\n* Absolute neutrophil count (ANC) \\> 1000\u002FμL\n* Absolute lymphocyte count \\> 100\u002FμL\n* Platelet count \\> 50,000\u002FµL\n* Estimated life expectancy of more than 3 months other than primary disease\n\nExclusion Criteria:\n\n* Primary CNS lymphoma (not applicable to CNS cohort)\n* Richter's transformed DLBCL arising from chronic lymphocytic leukemia (CLL) (not applicable to RT cohort)\n* Unable to give informed consent\n* Known history of infection with human immunodeficiency virus (HIV) or active hepatitis B (HBsAg positive). If there is a history of treated hepatitis B or hepatitis C, the viral load must be quantitative polymerase chain reaction (PCR) negative; antiviral prophylaxis is required if HBsAg negative and anti-HBc positive\n* Known history of infection with hepatitis C virus (anti-HCV positive) unless viral load is undetectable per quantitative PCR and\u002For nucleic acid testing.\n* Pharmacologically uncontrolled seizures.\n* Known history or presence of autoimmune CNS disease, such as multiple sclerosis, optic neuritis, or other immunologic or inflammatory disease\n* Presence of CNS disorder that, in the judgment of the Investigator, may impair the ability to evaluate neurotoxicity. For CNS Cohort:\n\n  * For CNSL and DLBCL transplant-ineligible 2nd-line cohort patients that have a CNS lesion(s): Midline shift on MRI or Abnormal high CSF opening pressure and or CSF protein ≥150 mg\u002FdL Recent (within 3 months) whole brain radiotherapy (WBRT) are exclusionary\n* Active systemic fungal, viral, or bacterial infection\n* Pregnant or breast-feeding woman\n* Previous or concurrent malignancy with the following exceptions:\n\n  * Adequately treated basal cell or squamous cell carcinoma (adequate wound healing required prior to study entry)\n  * In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 2 years prior to the study\n  * Adequately treated breast or prostate carcinoma on hormonal therapies such as Lupron or tamoxifen and in clinical remission of ≥ 2 years\n  * A primary malignancy which has been completely resected \u002F treated with curative intent and in complete remission of ≥ 2 years\n* Severely immunocompromised subjects e.g., due to current treatment of non-neurologic autoimmune disease (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus).\n* Medical condition requiring prolonged use of systemic corticosteroids equivalent to prednisone \\>10 mg\u002Fday. For CNS cohort: Up to 2 mg\u002Fday dexamethasone (or equivalence) may be allowed at any time, higher doses allowed up to 7 days prior to apheresis or after apheresis until lymphodepletion.\n* History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 6 months of enrollment.\n* Concurrent radiotherapy (allowed up to time of lymphodepletion). For prior systemic therapy, at least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed at the time of scheduled leukapheresis.\n* Baseline dementia that would interfere with therapy or monitoring, determined using Immune Effector Cell-Associated Encephalopathy (ICE) Assessment at baseline.\n* History of severe immediate hypersensitivity reaction to any of the agents used in this study.\n* Refusal to participate in additional lentiviral gene therapy long-term follow-up (LTFU) protocol\n* Prior CAR-T therapy for any indication or systemic gene modifying therapy for B-cell lymphoma\n* Prior allogeneic stem cell transplant for any indication\n* Prior Bispecific T cell engaging (BITE) antibodies for cancer therapy\n* Prior T cell receptor-engineered T cell therapy","ALL","18 Years",{"count":19,"type":20},315,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","DALY II USA is a phase II, multi-center, single arm study to evaluate the efficacy, safety, and pharmacokinetics of zamtocabtagene autoleucel (MB-CART2019.1) in patients with relapsed and\u002For refractory B cell lymphoma (BCL). Cohorts include subjects with diffuse large B-cell lymphoma (DLBCL) after receiving at least 2 lines of therapy, primary or secondary central nervous system (CNS) lymphoma (PCNSL) and (SCNSL) after receiving at least one line of therapy, mantle cell lymphoma (MCL) and Richter's transformation (RT) after receiving at least one line of therapy, and DLBCL transplant-ineligible after receiving at least one line of therapy.",[26,27,28,29,30,31,32,33,34],"Refractory Diffuse Large B Cell Lymphoma (DLBCL)","Relapsed Diffuse Large B Cell Lymphoma","High Grade B-cell Lymphoma (HGBCL)","Primary Mediastinal B-cell Lymphoma (PMBCL)","Transformed Lymphoma","Central Nervous System Lymphoma","Mantle Cell Lymphoma (MCL)","Richter Transformation","Transplant-ineligible 2nd Line DLBCL",[36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59],"CD19\u002FCD20-directed CAR-T Cells","Zamtocabtagene autoleucel","B-Cell Non-Hodgkin Lymphoma","Primary Central Nervous System Lymphoma","Secondary Central Nervous System Lymphoma","NHL","PCNSL","SCNSL","Chimeric Antigen Receptor","CAR","CAR-T Cell","Autologous T Cell Therapy","Central Nervous System Neoplasms","Lymphoma","Lymphoma, Non-Hodgkin","Lymphoma, B-Cell","Lymphoma, Large B-Cell, Diffuse","MCL","RT","CLL","Immunotherapy","T cells","T cell infusion","transplant-ineligible 2nd line DLBCL","RECRUITING","2026-07-09",{"date":63,"type":64},"2026-07-13","ACTUAL",{"date":66,"type":64},"2021-05-25",{"date":68,"type":20},"2028-12-31",{"name":70,"class":71},"Miltenyi Biomedicine GmbH","INDUSTRY",32,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":84,"conditions":85,"keywords":90,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},"100570561","phase-1-us-zamto-cel-autoimmune-diseases-100570561","NCT06708845","US Zamto-cel Autoimmune Diseases","A Phase I Multicohort Trial of Zamtocabtagene Autoleucel (Zamto-Cel) in Subjects With Severe Refractory Autoimmune Diseases","General Key Inclusion\u002FExclusion Criteria Across All Cohorts\n\nInclusion Criteria:\n\n•Confirmed diagnosis of autoimmune disease (SLE-Non-renal, SLE-LN, SSc\u002F dcSSc)\n\nExclusion Criteria:\n\n* Prior gene therapy treatment\n* Active malignancy within past 5 years\n* Significant active fungal or bacterial infection\n* History or presence of CNS lupus or other CNS disease\n* eGFR \\\u003C 45 mL\u002Fmin\u002F1.73 m\\^2\n* Total bilirubin outside the normal range (unless congenital hyperbilirubinemia such as Gilbert syndrome has been confirmed).\n\nSystemic Lupus Erythematosus-Non-renal Key Inclusion\u002FExclusion Criteria\n\nInclusion Criteria:\n\n* Positive for at least 1 of the following autoantibodies at Screening: anti- double stranded DNA or anti-Smith\n* Systemic Lupus Erythematosus Disease Activity Index-2000 score ≥ 8 AND at least 1 British Isles Lupus Assessment Group (BILAG)-2004 Class A (severe manifestation) organ scores\n* Inadequate response to glucocorticoids and to at least 2 of the following treatments, used for at least 3 months each: cyclophosphamide, mycophenolic acid or its derivatives, belimumab, azathioprine, anifrolumab, methotrexate, rituximab, or obinutuzumab\n\nExclusion Criteria:\n\n* Subjects with neuropsychiatric SLE.\n* Drug-induced SLE.\n\nSystemic Lupus Erythematosus - Lupus Nephritis Key Inclusion\u002FExclusion Criteria\n\nInclusion Criteria:\n\n* Positive for at least 1 of the following autoantibodies at Screening: anti- double stranded DNA or anti-Smith\n* Confirmed LN diagnosis by kidney biopsy during screening or within the previous 6 months, with severe active phase of the disease.\n* Progressing despite maintenance on maximally tolerated doses of renin- angiotensin system (RAS) blocking agents, unless allergic to or intolerant of ACE inhibitors and ARBs\n* Inadequate response to glucocorticoids and hydroxychloroquine and at least 1 of the following treatments, used for at least 3 months each: cyclophosphamide, mycophenolic acid derivatives, belimumab, azathioprine, methotrexate, rituximab, obinutuzumab, calcineurin inhibitor (cyclosporin, tacrolimus or voclosporin)\n\nExclusion Criteria:\n\n•Evidence of Rapidly progressive glomerulonephritis (defined as a doubling of serum creatinine within 3 months prior to enrollment) or as determined by the study investigator.\n\nSystemic Sclerosis\u002FDiffuse Cutaneous Systemic Sclerosis Cohort Key Inclusion\u002F Exclusion Criteria\n\nInclusion Criteria:\n\n* Active disease defined as:\n* Modified Rodnan skin score (mRSS) ≥ 16 units, in the prior 6 months, with 1 or more of the following:\n\n  * Increase in mRSS by ≥ 3 units or 10%\n  * Involvement of 1 new body area with increase in mRSS by ≥ 2 units\n  * Involvement of 2 new body areas with increase by ≥ 1 mRSS unit OR\n* Progressive interstitial lung disease (ILD) defined as:\n\n  \\- Worsening of respiratory symptoms and an increased extent of fibrosis evaluated by high-resolution computed tomography\n* Lack of response to standard therapy (e.g., failure of ≥ 2 immunosuppressive therapies)\n\nExclusion Criteria:\n\n* \"Active\" gastric antral vascular ectasia, as evidenced by bleeding (ie, on esophagogastroduodenoscopy) in the past 6 months or as per Investigator's assessment.\n* History of SSc renal crisis within 1 year prior to Screening; presence of kidney impairment due to conditions other than SSc",{"count":81,"type":20},48,[83],"PHASE1","AID is a phase I multi-cohort study to assess the safety and tolerability of zamtocabtagene autoleucel (zamto-cel) in patients with refractory autoimmune diseases (SLE-Non renal, SLE-LN, SSc\u002FdcSSc) after receiving standard therapy.",[86,87,88,89],"Lupus Nephritis","Systemic Lupus Erythematosus","Systemic Sclerosis (SSc)","Diffuse Cutaneous Systemic Sclerosis",[91,92,37,93,94,95,96,97,98,99],"Chimeric antigen receptor","CAR T","Autoimmune Disease","Immune System Diseases","SLE-Non renal","SLE-LN","SSc","dcSSc","Lupus","2026-06-09",{"date":102,"type":64},"2026-06-11",{"date":104,"type":20},"2026-07",{"date":106,"type":20},"2028-07",{"name":70,"class":71},1,{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":117,"enrollmentInfo":118,"targetDuration":4,"studyType":21,"phases":120,"briefSummary":121,"conditions":122,"keywords":124,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},"100427350","phase-2-efficacy-and-safety-of-mb-cart20191-vs-soc-in-lymphoma-patients-100427350","NCT04844866","Efficacy and Safety of MB-CART2019.1 vs. SoC in Lymphoma Patients","A Pivotal Phase II Randomised, Multi-centre, Open-label Study to Evaluate the Efficacy and Safety of MB-CART2019.1 Compared to SoC Therapy in Participants With r\u002Fr DLBCL, Who Are Not Eligible for HDC and ASCT","DALY 2-EU","Part I:\n\n1. Histologically proven DLBCL and associated subtypes, according to the World Health Organization (WHO) 2016 classification including:\n\n   * DLBCL not otherwise specified (NOS).\n   * High-grade B-cell lymphoma (HGBL) with MYC and BCL2 and\u002For BCL6 rearrangements with DLBCL\u002Fblastoid\u002Fintermediate histology or HGBL with MYC and BCL2 and\u002For BCL6 rearrangements (double hit lymphoma\u002Ftriple hit lymphoma).\n   * High-grade BCL, NOS.\n   * Primary (thymic) large mediastinal BCL.\n   * Disease transformed from an earlier diagnosis of low-grade lymphoma (e.g. an indolent pathology such as follicular lymphoma, marginal zone lymphoma) into DLBCL with DLBCL disease progression subsequent to DLBCL-directed systemic treatment.\n   * Follicular lymphoma Grade 3B.\n2. Relapsed or refractory disease after first-line chemoimmunotherapy:\n\n   * Refractory disease defined as no CR to first-line therapy (e.g. R-CHOP \\[rituximab, cyclophosphamide, daunorubicin, vincristine and prednisone\\]).\n\n     * Progressive disease (PD) after at least 2 full cycles of first-line therapy.\n     * Stable disease (SD) after 4 cycles of first-line therapy.\n     * PR as best response after at least 6 cycles of first-line therapy and biopsy-proven persistent disease (except where prohibited due to comorbidities) within ≤ 24 months from the start of the first-line therapy.\n   * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven disease progression (except where prohibited due to comorbidities) within ≤ 24 months from the start of the first-line therapy.\n3. Participants must have received adequate first-line therapy containing at least the combination of an anthracycline-based regimen and rituximab (anti-CD20 monoclonal antibody). Local therapies (e.g. radiotherapies) will not be considered as line of therapy if performed during the same line of treatment.\n4. Archival paraffin-embedded tumour tissue acquired ≤ 2 years (preferred: ≤ 2 months) prior to screening for the central pathology review to confirm DLBCL diagnosis must be made available for participation in this study. If archival paraffin-embedded tumour tissue is not available, fresh tumour tissue sample (preferred) or core-needle biopsy must be made available for the central pathology review.\n5. Participants deemed ineligible to receive HDC followed by ASCT based on the treating physician's assessment and meeting the following criteria:\n\n   EITHER\n   * Age ≥ 18 years and\n\n     * Prior ASCT (as first-line consolidation) or\n     * Haematopoietic cell transplantation-specific comorbidity index (HCT-CI) \\> 3. OR\n   * Age ≥ 65 years and ≥ 1of the criteria below:\n\n     * Impaired cardiac function (left ventricular ejection fraction \\[LVEF\\] \\\u003C 50%), or\n     * Impaired renal function (estimated glomerular filtration rate \\[eGFR\\] \\\u003C 60 mL\u002Fmin) calculated according to the modified Modification of Diet in Renal Disease (MDRD) formula, or\n     * Impaired pulmonary function (diffusing capacity for carbon monoxide or forced expiratory volume in 1 second \\\u003C 80%) or dyspnoea on slight activity, or\n     * Eastern Cooperative Oncology Group (ECOG) performance status \\> 1. OR\n   * Age ≥ 70 years. Documentation of the reason for ineligibility for ASCT must be present in the participant's source data.\n\n   In addition, all participants must fulfil the following criteria:\n6. Age ≥ 18 years.\n7. Measurable disease according to Lugano criteria. The lesion must be measurable (nodes \\> 1.5 cm in the long axis; extranodal lesions \\> 1 cm in the long axis) and positive on a positron emission tomography scan.\n8. Estimated life expectancy of \\> 3 months for other reasons than the primary disease.\n9. Women of childbearing potential (WOCBP) must agree to use highly effective contraceptive measures (Pearl index \\\u003C 1) or practice true sexual abstinence from any heterosexual intercourse (True abstinence is only acceptable if it is in line with the preferred and usual life style of the participant.) or must have a vasectomised partner as the sole sexual partner (The vasectomised partner must have received medical assessment of the surgical success.) for at least 1 month before the study start, during the study and in the 12 months following the last dose of study treatment. A woman is considered a WOCBP, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Highly effective methods of contraception include hormonal contraceptives associated with inhibition of ovulation (oral, intravaginal, transdermal, injectable, implantable) and intrauterine devices or systems (e.g. hormonal and non-hormonal) and bilateral tubal occlusion. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A post-menopausal state is defined as no menses for 12 months without an alternative medical cause. WOCBP who want to become pregnant after completing treatment should seek advice about oocyte cryoconservation prior to treatment because of possible irreversible infertility. WOCBP must refrain from egg donation throughout the study until 12 months after the last dose of study treatment.\n\n   Men with non-pregnant WOCBP partners must agree to use highly effective contraceptive measures (Pearl index \\\u003C 1, e.g. spermicide and condom or other highly effective contraceptive measures (Pearl index \\\u003C 1) taken by their WOCBP partner) or practice true sexual abstinence from any heterosexual intercourse (True abstinence is only acceptable if it is in line with the preferred and usual life style of the participant.), unless they are surgically sterile (meaning at least 2 consecutive analyses following vasectomy demonstrate absence of sperms in the ejaculate), during the study and in the 12 months following the last dose of study treatment. Men should seek advice about sperm conservation prior to treatment because of possible irreversible infertility. Men must furthermore refrain from sperm donation throughout the study until 12 months after the last administration of study treatment.\n10. In the opinion of the investigator, the participant must be able to comply with all study-related procedures, medication use and evaluations.\n11. Mental capacity and legal ability to consent to participation in the clinical study.\n\nCriteria for Exclusion:\n\n1. Contraindications for R-GemOx, BR plus polatuzumab vedotin, cyclophosphamide and fludarabine as judged by the treating physician.\n2. Prior chimeric antigen receptor therapy or other genetically modified T-cell therapy.\n3. Participants who have received more than one line of treatment for DLBCL or associated subtypes.\n4. Prior haematopoietic stem cell transplantation (HSCT; as first-line consolidation) \\\u003C 3 months at the time of leukapheresis.\n5. ECOG performance status \\> 2.\n6. Absolute neutrophil count \\\u003C 1,000\u002FμL (unless secondary to bone marrow involvement by DLBCL as demonstrated by bone marrow biopsy).\n7. Platelet count \\\u003C 50,000\u002FμL (unless secondary to bone marrow involvement by DLBCL as demonstrated by bone marrow biopsy).\n8. Absolute lymphocyte count \\\u003C 100\u002FμL.\n9. Participants who have central nervous system (CNS) lymphoma involvement in present or past medical history.\n10. Participants with the requirement for urgent therapy due to tumour mass effects.\n11. Infection with human immunodeficiency virus.\n12. Presence of active or prior hepatitis B or C as indicated by serology (for detailed criteria see Section 10.2.7.10). Treated infection with hepatitis B or C virus unless confirmed to be polymerase chain reaction negative.\n13. Active infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).\n14. Active, severe systemic fungal, viral or bacterial infection.\n15. Known history or evidence of severely immunocompromised state, i.e. corticosteroid treatment \\> 10 mg\u002Fday for more than 6 months.\n16. Has received vaccination with live virus vaccines 6 weeks prior to randomisation.\n17. Prior CD19-targeted therapy.\n18. Known history or presence of seizure activities or on active anti-seizure medications within the previous 12 months.\n19. History or presence of non-malignant CNS disease that, in the judgement of the investigator, may impair the ability to evaluate neurotoxicity.\n20. Known history or presence of autoimmune CNS disease, such as multiple sclerosis, optic neuritis or other immunologic or inflammatory disease.\n21. Known history or presence of cerebral vascular accident (CVA) within 12 months prior to randomisation.\n\n    Note: In case of history of CVA \\> 12 months prior to leukapheresis, then the participant must not have any unstable or life-threatening neurological deficits.\n22. Participants with Richter's transformation or Richter's syndrome.\n23. Participants who are concurrently on any other experimental treatments or during the previous 4 weeks or 5 half-lives.\n24. Clinical heart failure with New York Heart Association class ≥ 2 or LVEF \\\u003C 30% or severe cardiac arrhythmias or QT prolongation (resting QTcF ≥ 450 msec \\[male\\] or ≥ 460 msec \\[female\\] at screening) that would (according to the evaluation of the investigator) face an uncontrollable risk by receiving the medications administered in the trial.\n25. Resting peripheral oxygen saturation \\\u003C 90% on room air.\n26. Liver dysfunction as indicated by total bilirubin \\> 2.5 × institutional upper limit of normal (ULN), aspartate aminotransferase and\u002For alanine aminotransferase \\> 5 × ULN or typical symptoms like jaundice.\n27. Serum creatinine ≥ 2.0 × ULN or eGFR \\\u003C 30 mL\u002Fmin calculated according to the modified MDRD formula.\n28. Pregnant or breast-feeding women.\n29. Prior history of malignancies other than DLBCL. Exceptions include participants who have been free of the disease for ≥ 3 years prior to screening and participants with adequately treated and removed basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, carcinoma in situ of the bladder or incidental histological finding of untreated localised (T1a, T1b or T1c) prostate cancer under surveillance.\n30. History of severe immediate hypersensitivity to any investigational medicinal product (IMP), auxiliary medicinal product (AxMP), premedication or rescue medication or its excipients that is scheduled to be given during study participation.\n31. Major surgery less than 30 days before start of treatment.\n32. Any medical condition likely to interfere with assessment of safety or efficacy of study treatment.\n\nPart II:\n\n1. Histologically proven DLBCL and associated subtypes, according to the WHO 2016 classification including:\n\n   * DLBCL, NOS.\n   * HGBL with MYC and BCL2 and\u002For BCL6 rearrangements with DLBCL\u002Fblastoid\u002Fintermediate histology or HGBL with MYC and BCL2 and\u002For BCL6 rearrangements (double hit lymphoma\u002Ftriple hit lymphoma).\n   * High-grade BCL, NOS.\n   * Primary (thymic) large mediastinal BCL.\n   * Disease transformed from an earlier diagnosis of low-grade lymphoma (e.g., an indolent pathology such as follicular lymphoma, marginal zone lymphoma) into DLBCL with DLBCL disease progression subsequent to DLBCL-directed systemic treatment.\n   * Follicular lymphoma Grade 3B.\n2. Relapsed or refractory disease after first-line chemoimmunotherapy:\n\n   * Refractory disease defined as no CR to first-line therapy (e.g., R-CHOP).\n\n     * PD after at least 2 full cycles of first-line therapy.\n     * SD after 4 cycles of first-line therapy.\n     * PR as best response after at least 6 cycles of first-line therapy and biopsy-proven persistent disease (except where prohibited due to comorbidities) within ≤ 12 months after completion of first-line treatment.\n   * Relapsed disease defined as complete remission to first-line therapy followed by biopsy-proven disease progression (except where prohibited due to comorbidities) within ≤ 12 months after completion of first-line treatment.\n3. Participant must have received adequate first-line therapy containing at least the combination of an anthracycline-based regimen and rituximab (anti-CD20 monoclonal antibody). Local therapies (e.g., radiotherapies) will not be considered as line of therapy if performed during the same line of treatment.\n4. Archival paraffin-embedded tumour tissue acquired ≤ 2 years (preferred: ≤ 2 months) prior to screening for the central pathology review to confirm DLBCL diagnosis must be made available for participation in this study. If archival paraffin-embedded tumour tissue is not available, fresh tumour tissue sample (preferred) or core-needle biopsy must be made available for the central pathology review.\n5. Measurable disease according to Lugano criteria. The lesion must be measurable (nodes \\> 1.5 cm in the long axis; extranodal lesions \\> 1 cm in the long axis) and positive on a positron emission tomography scan.\n6. Approved treatment options not suitable according to investigator's assessment.\n\n   In addition, all participants must fulfil the following criteria:\n7. Age ≥ 18 and ≤ 70 years.\n8. Estimated life expectancy of \\> 3 months for other reasons than the primary disease.\n9. ECOG 0-1.\n10. Adequate bone marrow function, defined as:\n\n    * Absolute neutrophil count ≥ 1,000\u002FμL (unless secondary to bone marrow involvement by DLBCL as demonstrated by bone marrow biopsy).\n    * Platelet count ≥ 50,000\u002FμL (unless secondary to bone marrow involvement by DLBCL as demonstrated by bone marrow biopsy).\n    * Absolute lymphocyte count ≥ 100\u002FμL.\n11. Adequate organ function, defined as:\n\n    * New York Heart Association class \\\u003C 2 or LVEF ≥ 50%.\n    * No severe cardiac arrhythmias or QT prolongation (resting QTcF \\\u003C 450 msec \\[male\\] or \\\u003C 460 msec \\[female\\] at screening).\n    * No clinically relevant pleural effusion or pericardial effusion.\n    * Resting peripheral oxygen saturation ≥ 92% on room air.\n    * Total bilirubin ≤ 2.0 × ULN, AST and\u002For ALT ≤ 5 × ULN\n    * Serum creatinine \\\u003C 1.0 × ULN or eGFR (according to modified MDRD formula) ≥ 60 mL\u002Fmin.\n12. WOCBP must agree to use highly effective contraceptive measures (Pearl index \\\u003C 1) or practice true sexual abstinence from any heterosexual intercourse (True abstinence is only acceptable if it is in line with the preferred and usual life style of the participant.) or must have a vasectomised partner as the sole sexual partner (The vasectomised partner must have received medical assessment of the surgical success.) for at least 1 month before the study start, during the study and in the 12 months following the last dose of study treatment. A woman is considered a WOCBP, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Highly effective methods of contraception include hormonal contraceptives associated with inhibition of ovulation (oral, intravaginal, transdermal, injectable, implantable) and intrauterine devices or systems (e.g., hormonal and non-hormonal) and bilateral tubal occlusion. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A post-menopausal state is defined as no menses for 12 months without an alternative medical cause. WOCBP who want to become pregnant after completing treatment should seek advice about oocyte cryoconservation prior to treatment because of possible irreversible infertility. WOCBP must refrain from egg donation throughout the study until 12 months after the last dose of study treatment. Men with non-pregnant WOCBP partners must agree to use highly effective contraceptive measures (Pearl index \\\u003C 1, e.g., spermicide and condom or other highly effective contraceptive measures (Pearl index \\\u003C 1) taken by their WOCBP partner) or practice true sexual abstinence from any heterosexual intercourse (True abstinence is only acceptable if it is in line with the preferred and usual life style of the participant.), unless they are surgically sterile (meaning at least 2 consecutive analyses following vasectomy demonstrate absence of sperms in the ejaculate), during the study and in the 12 months following the last dose of study treatment. Men should seek advice about sperm conservation prior to treatment because of possible irreversible infertility. Men must furthermore refrain from sperm donation throughout the study until 12 months after the last administration of study treatment.\n13. In the opinion of the investigator, the participant must be able to comply with all study-related procedures, medication use and evaluations.\n14. Mental capacity and legal ability to consent to participation in the clinical study.\n\nCriteria for Exclusion:\n\n1. Contraindications for cyclophosphamide and fludarabine as judged by the treating physician.\n2. Prior chimeric antigen receptor therapy or other genetically modified T-cell therapy.\n3. Participants who have received more than one line of prior therapy for DLBCL or associated subtypes.\n4. Prior HSCT (as first-line consolidation) \\\u003C 3 months at the time of leukapheresis.\n5. Participants who have CNS lymphoma involvement in present or past medical history.\n6. Participants with the requirement for urgent therapy due to tumour mass effects.\n7. Infection with human immunodeficiency virus.\n8. Presence of active or prior hepatitis B or C as indicated by serology. Treated infection with hepatitis B or C virus unless confirmed to be polymerase chain reaction negative.\n9. Infection with Treponema pallidum (pathogen causing syphilis).\n10. Infection with human T-lymphotropic virus 1.\n11. Active infection with SARS-CoV-2.\n12. Active, severe systemic fungal, viral, or bacterial infection.\n13. Known history or evidence of severely immunocompromised state, i.e. corticosteroid treatment \\> 10 mg\u002Fday for more than 6 months.\n14. Has received vaccination with live virus vaccines within 6 weeks prior to randomisation.\n15. Prior CD19-targeted therapy.\n16. Known history or presence of seizure activities or on active anti-seizure medications within the previous 12 months.\n17. History or presence of non-malignant CNS disease that, in the judgement of the investigator, may impair the ability to evaluate neurotoxicity.\n18. Known history or presence of autoimmune CNS disease, such as multiple sclerosis, optic neuritis or other immunologic or inflammatory disease.\n19. Known history or presence of CVA within 12 months prior to randomisation. Note: In case of history of CVA \\> 12 months prior to leukapheresis, then the participant must not have any unstable or life-threatening neurological deficits.\n20. Participants with Richter's transformation or Richter's syndrome.\n21. Participants who are concurrently on any other experimental treatments or during the previous 4 weeks or 5 half-lives.\n22. Pregnant or breastfeeding woman.\n23. Prior history of malignancies other than DLBCL. Exceptions include participants who have been free of the disease for ≥ 3 years prior to screening and participants with adequately treated and removed basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, carcinoma in situ of the bladder or incidental histological finding of untreated localised (T1a, T1b or T1c) prostate cancer under surveillance.\n24. History of severe immediate hypersensitivity to any IMP, AxMP, premedication or rescue medication or its excipients that is scheduled to be given during study participation.\n25. Major surgery less than 30 days before start of treatment.\n26. Any medical condition likely to interfere with assessment of safety or efficacy of study treatment.","70 Years",{"count":119,"type":20},213,[23],"In the current protocol version, there are two parts. Part I is a pivotal Phase II randomised, multi-centre, open-label study to evaluate the efficacy and safety of MB-CART2019.1 compared to standard of care therapy in participants with relapsed\u002Frefractory diffuse large B-cell lymphoma, who are not eligible for high-dose chemotherapy and autologous stem cell transplantation.\n\nPart II is a Phase II single-arm, open-label, multi-centre study evaluating the efficacy and safety of MB-CART2019.1 in younger, fit participants with R-R DLBCL. Part II will start after completion of enrolment in Part I.",[123],"Diffuse Large B-cell Lymphoma",[125,126,127,128,129,130,123,131,132,41,133,134,135,136],"CAR T cells","chimeric antigen receptor","MB-CART2019.1","CD20","CD19","relapsed refractory","DLBCL","Non-Hodgkin Lymphoma","zamtocabtagene autoleucel","blood cancer","LBCL","Follicular Lymphoma 3B","2026-06-08",{"date":139,"type":64},"2026-06-10",{"date":141,"type":64},"2021-08-18",{"date":143,"type":20},"2031-09-30",{"name":70,"class":71},51,{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":153,"enrollmentInfo":154,"targetDuration":4,"studyType":21,"phases":156,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":108},"100606659","phase-1-mb-cart20191-in-refractory-multiple-sclerosis-100606659","NCT07178431","MB-CART2019.1 in Refractory Multiple Sclerosis","An Open Label Phase I\u002FIIa, Multicenter, Interventional Single-arm Trial of MB-CART 2019.1 in Patients With Refractory Multiple Sclerosis (MS)","Inclusion Criteria:\n\nIndividuals must meet all of the following criteria to be included in the trial:\n\n1. Have read, understood and signed\u002Fdated the informed consent form.\n2. Age ≥18 years at the time of screening.\n3. Diagnosis of multiple sclerosis fulfilling the 2017 McDonald criteria.\n4. Progressive or worsening MS according to 2014 Lublin MS phenotypic criteria\n5. Disease activity despite treatment:\n\n   1. Definition for RRMS\u002FSPMS:\n\n      1 or more relapses or an EDSS deterioration in the previous year (1 point or more if EDSS is between 3 and 5.5; 0.5 point or more if EDSS 6-6.5) or MRI activity (presence of at least 2 new\u002Fenlarging T2 lesions or T1CE lesions) despite on\u002Fprevious treatment with an escalation therapy drug (i.e. natalizumab, ofatumumab, ocrelizumab, alemtuzumab or mitoxantrone) for at least 6 months.\n   2. Definition for PPMS:\n\n      EDSS deterioration in the previous year (1 point or more if EDSS between 3 and 5.5; 0.5 point or more if EDSS 6-6.5) or MRI activity (presence of at least 2 new\u002Fenlarging T2 lesions or T1CE lesions) despite on\u002Fprevious treatment with ocrelizumab (treatment duration ≥ 6 months).\n   3. Evidence of intrathecal IgG production through oligoclonal bands (OCBs) present in the cerebrospinal fluid in PPMS or SPMS.\n6. Fully vaccinated against Hepatitis B.\n7. Presence of varicella-zoster virus (VZV) antibodies, or completion of at least one dose of varicella zoster glycoprotein E Shingrix vaccine at least 4 weeks prior to treatment.\n8. Presence of anti EBV antibodies\n9. Organ function \u002F lab parameters as follows\n\n   1. Absolute Neutrophil count \\> 2000\u002FuL\n   2. Platelets \\> 150,000\u002FuL\n   3. Absolute Lymphocyte count \\> 1000\u002FuL\n   4. Serum IgG \\> 500 mg\u002Fdl\n   5. Hemoglobin \\> 9g\u002Fdl\n10. Adequate renal, hepatic, pulmonary and cardiac function defined as\n\n    1. Creatinine ,\\\u003C 2mg\u002Fdl or creatinine clearance \\> to 60ml\u002Fmin\n    2. ALT\u002FAST \\\u003C 3x ULN\n    3. Total bilirubin \\\u003C 1,5 mg\u002Fdl, except for subjects with Gilbert syndrome.\n    4. Cardiac ejection fraction \\> 40%, no evidence of significant pericardial effusion (echography) or clinically significant ECG findings\n    5. Baseline oxygen saturation \\> 94% on air room\n11. Negative test for Hepatitis B core antibody and Hepatitis C core antibody, CMV, VZ, Herpes simplex virus 1 and 2 ab\n12. Negative test for Myelin-Oligodendrocyte-Glycoprotein (MOG) and Aquaporin-4 (AQP-4) autoantibodies\n13. Women of childbearing potential (WOCBP) must be able and willing to use at least one highly effective method of contraception from the time of consent until 12 months after the administration of MB-CART2019.1. WOCBP must refrain from donating eggs during the same period. A woman is considered of childbearing potential, i.e., fertile, following menarche and until having been postmenopausal for at least 12 months or unless otherwise permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. For the definition and a list of highly effective methods of contraception, see Appendix 1 Contraception Guidelines.\n14. Men whose sexual partners are WOCBP must be able and willing to use at least one highly effective method of contraception (used by themselves or their female partners; see Appendix 1 Contraception Guidelines) from the time of consent until 12 months after the administration of MB-CART2019.1.\n15. Willingness and ability to comply with all trial procedures.\n16. Adequate vital signs.\n\nExclusion Criteria:\n\nPatients will be entered into this trial only if they meet none of the following criteria:\n\n1. For relapsing and progressive MS forms: the disability status according to the EDSS scale is larger than 7.0 or the age is larger than 55 years.\n\n   Only applicable for progressive MS (PPMS\u002FSPMS), where the disease duration is longer than 15 years.\n2. History of a malignancy unless disease free for ≥5 years with the exception of basal or squamous cell skin cancer\n3. Known history of and\u002For active infection with hepatitis B (hepatitis B surface antigen positive)\n4. Known history of infection with hepatitis C virus unless treated and confirmed to be polymerase chain reaction (PCR) negative\n5. Any active uncontrolled bacterial, viral or fungal infection\n6. A history of and\u002For active infection with human immunodeficiency virus (HIV)\n7. A history of active or latent tuberculosis (TB); TB testing should be performed at screening (Quantiferon test). Confirmed active or latent TB the patient can be re-screened after full completion of anti-tuberculosis treatment (9 months of Isoniazide therapy)\n8. History of neuromyelitis optica spectrum disorder (NMOSD) or MOG antibody associated disease.\n9. History of CNS or spinal cord tumor, metabolic or infectious causes of myelopathy, genetically inherited progressive CNS disorder, sarcoidosis or non MS-progressive neurological condition affecting the ability to perform the study assessments\n10. History of cytopenia consistent with MDS diagnosis\n11. History of sickle cell anemia or other hemoglinopathies\n12. Primary immune deficiency disease\n13. Patients with positive antiphospholipid antibodies, anti-cardiolipin or lupus anticoagulant.\n14. History of moderate or worse renal impairment (eGFR \\\u003C 30 ml\u002Fmin\u002F1.73 m2)\n15. Prevalent inflammatory diseases of the GI tract (e.g. Inflammatory bowel disease, Peptic ulcer) which could result in a higher risk for gastrointestinal perforation.\n16. The following cardiac conditions:\n\n    New York Heart Association Stage III or IV congestive heart failure Myocardial infarction or coronary artery bypass graft ≤ 6 months prior to enrollment History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration\n17. History of severe non-ischemic cardiomyopathy Medications:\n\n    Systemic corticosteroids \\>10 mg within 7 days prior to leukapheresis; T cell targeting drugs (e.g. mycophenolate mofetil, calcineurin inhibitors) within 21 days prior to leukapheresis, Previous CAR T cell therapy, Live vaccines within 30 days prior to leukapheresis, Current Cytotoxic drugs Other MS disease modifying drugs (as stated in 5.8.1.)\n18. Hypersensitivity against any drug or its ingredients\u002Fimpurities that is scheduled or likely to be given during trial participation, e.g. as part of the mandatory preparative lymphodepletion or rescue medication\u002Fsalvage therapies for treatment related toxicities;\n19. Contraindication of trial related procedures as judged by the investigator\n20. Pregnant of breast-feeding females; female patients of child-bearing potential not willing to practice a highly effective form of birth control from leukapheresis and for 12 months after dosing the IMP\n21. Concurrent participation in another interventional trial\n22. Inability to understand the procedures and risks associated with the Trial.\n23. Any additional contraindication of trial related procedures as judged by the investigator","55 Years",{"count":155,"type":20},26,[83,23],"The goal of this trial is to assess the feasibility, safety and preliminary efficacy of MB-CART2019.1 in patients with active refractory primary and secondary progressive MS.",[159,160],"Multiple Sclerosis","CAR T Cell Therapy","2026-05-06",{"date":163,"type":64},"2026-05-11",{"date":165,"type":64},"2026-04-01",{"date":167,"type":20},"2030-08-16",{"name":70,"class":71},{"id":170,"slug":171,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":16,"minAge":177,"maxAge":178,"enrollmentInfo":179,"targetDuration":4,"studyType":21,"phases":181,"briefSummary":182,"conditions":183,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":193},"100555195","phase-2-safety-and-efficacy-study-of-zamtocabtagene-autoleucel-mb-cart20191-in-pediatric-patients-with-rr-b-cell-neoplasms-100555195","NCT06508931","Safety and Efficacy Study of Zamtocabtagene Autoleucel (MB-CART2019.1) in Pediatric Patients With R\u002FR B-Cell Neoplasms","A Single-arm, Multi-center, Open-label Phase II Study to Determine the Safety and Efficacy of MB-CART2019.1 in Pediatric Subjects With Relapsed\u002FRefractory Mature B-cell Neoplasms Who Have Relapsed After One or More Prior Therapies, Including Subjects With Primary Refractory Disease","DALY PED","Inclusion Criteria:\n\n1. Is able to provide age-appropriate assent\u002Fconsent (as applicable, according to local legislation) and\u002For have a guardian able to provide consent signed and dated by the parent(s) or by subject's legal guardian before conduct of any study-specific procedures.\n2. Has histologically confirmed mature CD19+ and\u002For CD20+ B-cell neoplasm such as:\n\n   * Burkitt lymphoma\u002FBurkitt leukemia\n   * Diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS)\n   * Primary mediastinal (thymic) large B-cell lymphoma\n   * Burkitt-like lymphoma with 11q aberration\n   * Aggressive mature B-cell lymphoma\n   * Other rare aggressive B-cell non-Hodgkin lymphoma (NHL) after sponsor approval.\n3. Has r\u002Fr B-cell neoplasms after one or more prior therapies or primary refractory to first-line therapy.\n4. Is a pediatric\u002Fadolescent (aged between 6 months and \\\u003C18 years).\n5. Has a BW of ≥ 6 kg.\n6. Measurable disease based on the International Pediatric NHL Response Criteria (which refers to the Lugano criteria for definitions of measurability and selecting index lesions), as identified by local radiological assessment for lymphomas. Previously irradiated lesions cannot be considered measurable unless the lesion has proven radiological evidence for progression after the radiation.\n7. Tissue samples archival or fresh (preferred) from recent relapse or initial diagnosis (in case of primary refractory disease) must be made available for the central pathology review to confirm diagnosis (≤2 years, preferably not older than 2 months since collection).\n8. Has Karnofsky (aged ≥16 years) or Lansky (aged \\\u003C16 years) performance status ≥60.\n9. Has adequate bone marrow function as defined by the following laboratory values (as assessed by local laboratory for eligibility):\n\n   * Absolute neutrophil count (ANC) \\>1000\u002FμL.\n   * Platelets ≥50000\u002FμL.\n   * Hemoglobin ≥8.0 g\u002FdL.\n   * Absolute lymphocyte count ≥100\u002FμL.\n10. Has adequate organ function as follows:\n\n    * Renal function: estimated glomerular filtration rate (eGFR) \\>29 mL\u002Fmin by Schwartz formula (Schwartz et al 1976).\n    * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5 × upper limit of normal (ULN) for age.\n    * Bilirubin \\\u003C1.5 x ULN (for Gilbert's Syndrome, subject's total bilirubin \\\u003C4 mg\u002FdL).\n    * Adequate pulmonary function as follows:\n\n      * Resting oxygen saturation of ≥91% on room air.\n      * No or mild dyspnea (Grade ≤1).\n11. Female subjects of childbearing potential must be willing to undergo pregnancy tests before MB-CART2019.1 infusion.\n12. If subjects are sexually active, they must be willing to use highly effective methods of contraception.\n\n    * Female subjects must agree to use two methods of contraception;\n\n      * one of the following methods (Pearl index \\\u003C1%): Hormonal contraceptives associated with inhibition of ovulation (oral, intravaginal, injected, implanted, transdermal), intrauterine devices (IUDs) or systems (e.g., hormonal and non-hormonal IUD), or vasectomized sexual partner AND one barrier method.\n      * Highly effective methods of contraception must be followed from inclusion until 12 months after MB-CART2019.1 infusion.\n    * Male subjects must agree to use a condom during intercourse from inclusion through at least 12 months after MB-CART2019.1 infusion to prevent them from fathering a child AND to prevent delivery of MB-CART2019.1 via seminal fluid to their partner. Do not use a female condom when using a male condom, since tearing can occur. In addition, male subjects must not donate sperm for the time period specified above.\n    * Females must agree not to breast feed or donate eggs\u002Fova during the study and until at least 12 months after MB-CART2019.1 infusion.\n13. Is willing to undergo collection of non-mobilized leukapheresis.\n14. In the opinion of the investigator, the subject must be able to comply with all study-related procedures, medication use, and assessments.\n\nExclusion Criteria:\n\n1. Is receiving active treatment for malignant disease (including participation in any additional parallel investigational drug or device studies), except for pre-enrollment therapy, including radiotherapy. Lesions that are irradiated during pre-enrollment therapy may not be considered measurable lesions. For subjects with lymphoma to be eligible, there must be at least one measurable lesion after pre-enrollment therapy.\n2. Had allogeneic HSCT.\n3. Had autologous HSCT \\\u003C120 days prior to written informed consent.\n4. Had major surgery within 2 weeks before leukapheresis, or has not fully recovered from an earlier surgery, or has major surgery planned during the time the subject is expected to participate in the study.\n5. Subjects with B-cell neoplasms in the context of post-transplant lymphoproliferative disorders-associated lymphomas.\n6. Has known hypersensitivity to the excipients of the MB-CART2019.1 or to any other drug product as advised for administration in the study protocol (e.g., lymphodepleting agents).\n7. Has active central nervous system (CNS) involvement at the time point of eligibility confirmation, as measured by the presence of lymphoma cells in cerebral spinal fluid (CSF) on cytospin preparation.\n8. Has history or presence of autoimmune CNS disease, such as multiple sclerosis, optic neuritis, or other immunologic or inflammatory diseases.\n9. Infection with human immunodeficiency virus (HIV).\n10. Presence of active or prior hepatitis B or C as indicated by serology. Treated infection with hepatitis B or C virus unless confirmed to be polymerase chain reaction (PCR) negative.\n11. Has infection with Treponema pallidum.\n12. Has active infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).\n13. Has infection with human T-lymphotropic virus 1\u002F2 (HTLV 1\u002F2).\n14. Has active severe systemic fungal, viral, or bacterial infection, requiring systemic antiviral, antifungal, or antimicrobial therapy.\n15. Has clinically significant seizures according to the opinion of by the investigator.\n16. Has history of cerebral vascular accident within 12 months prior to leukapheresis.\n17. Has impaired cardiac function: Fractional shortening \\\u003C28% or left ventricular ejection fraction \\\u003C50% by echocardiography or multigated acquisition, if allowed as per local law.\n18. Has concomitant genetic syndromes associated with bone marrow (BM) failure status, such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known BM failure syndrome.\n19. Is a pregnant or breast-feeding female.\n20. Is sexually active and not willing to use highly effective methods of contraception as described in the inclusion criteria.\n21. Has history of another malignancy within the prior 3 years that required systemic therapy.\n22. Has other medical, psychological, or social condition that, in the opinion of the investigator, would impact subject safety or confound the study results.\n23. Has received vaccination with live virus within 6 weeks prior to informed consent.\n24. Has been previously treated with approved anti-CD19 or anti-CD20 CART cell therapies \\\u003C100 days prior to informed consent\u002Fassent.","6 Months","17 Years",{"count":180,"type":20},31,[23],"This is a single-arm, multi-center, open-label Phase II study to determine the safety and efficacy of MB-CART2019.1 in pediatric and adolescent subjects (aged between 6 months and \\\u003C18 years, ≥6 kg body weight \\[BW\\]) with mature B-cell neoplasms and aggressive lymphomas that relapsed after or are refractory to one or more prior therapies, including subjects with primary refractory disease.",[184],"B-Cell Neoplasm","2026-05-04",{"date":187,"type":64},"2026-05-05",{"date":189,"type":64},"2025-08-04",{"date":191,"type":20},"2029-12-31",{"name":70,"class":71},5,{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":200,"eligibilityCriteria":201,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":202,"targetDuration":4,"studyType":21,"phases":204,"briefSummary":205,"conditions":206,"keywords":207,"overallStatus":212,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"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":203,"type":20},52,[23],"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",[32],[36,37,38,44,45,46,50,51,53,56,58,208,209,210,211],"High-risk","Mantle Cell Lymphoma","Frontline","TP53","NOT_YET_RECRUITING","2026-04-28",{"date":161,"type":64},{"date":216,"type":20},"2026-09",{"date":218,"type":20},"2030-03",{"name":70,"class":71},{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":227,"targetDuration":4,"studyType":21,"phases":229,"briefSummary":230,"conditions":231,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":108},"100548695","phase-1-mb-dnpm1-tcr1-in-relapsedrefractory-aml-100548695","NCT06424340","MB-dNPM1-TCR.1 in Relapsed\u002FRefractory AML","A Phase I\u002FII Trial of MB-dNPM1-TCR.1 in HLA-A*02:01-positive Patients With Relapsed or Refractory NPM1-mutated AML to Determine Safety and Obtain First Data on Efficacy","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Patients must be able to understand and be willing to give signed informed consent\n3. Relapsed or refractory acute myeloid leukemia (last disease staging within 4 weeks prior to screening) without standard treatment options defined as:\n\n   * No morphological CR or extramedullary AML after at least two courses of intensive chemotherapy, decitabine or other standard therapy or\n   * MRD positive after at least two courses of intensive chemotherapy or other standard therapy and not eligible for allogeneic stem cell transplantation or\n   * Relapsed bone marrow or blood disease or extramedullary AML after CR after first line treatment and not eligible to undergo allogeneic stem cell transplantation or\n   * Bone marrow, blood, extramedullary AML relapse or non-response or MRD positivity after allogeneic stem cell transplantation and not eligible to receive Donor Lymphocyte Infusion (DLI) according to local standards, relapse or MRD positive after DLI.\n4. Positive for HLA-A\\*02:01 according to genotyping results.\n5. AML has NPM1 mutation which is recognized by dNPM1-TCR.1 and for which a specific Q-PCR is available for disease monitoring.\n6. Number of circulating WBC above 1x109\u002FL with less than 50% leukemic blasts and 0.03 x 109 CD8+ T cells\u002FL.\n7. Life expectancy of at least 3 months.\n8. ECOG performance status 0-3.\n9. Negative pregnancy test in women of childbearing potential.\n10. For fertile men and women, agreement to use highly effective contraceptive methods during the trial.\n\nExclusion Criteria:\n\n1. Pregnant or breast feeding women.\n2. Active infection with HIV-1, HIV-2, HBV, HCV, HTLV-I, HTLV-II, SARS-CoV-2 or Treponema Pallidum.\n3. Any clinically significant, advanced or unstable disease or inadequate main organ function that may put the patient at increased risk for severe complications of trial participation at the discretion of the investigator.\n4. Use of systemic immune suppression including, but not limited to:\n\n   immunosuppressive agents such as cyclosporine or corticosteroids (at an equivalent dose of 0.5 mg prednisone\u002Fkg body weight per day, or higher). Inhaled steroid and physiological replacement for adrenal insufficiency are allowed.\n5. Unwillingness or inability to comply with procedures required in this clinical trial protocol.\n6. Uncontrolled life-threatening infections or uncontrolled disseminated intravascular coagulation; however, if these problems resolve, the start of treatment can be initiated on a delayed schedule.\n7. Subjects currently on any other IMP (including within the last 30 days before start of treatment).\n8. Current use of high dose immunosuppression for immune disorders interfering with T cell function (on discretion of the investigator).\n9. Known hypersensitivity against any drug of the mandatory trial procedures.\n10. Serum creatinine ≥ 2.0 × ULN or eGFR \\\u003C 30 mL\u002Fmin calculated according to the modified MDRD formula.\n11. BMI ≥40\n12. Has received vaccination with live vaccines 6 weeks prior to treatment\n13. Major surgery less than 30 days before start of treatment.\n14. Committal to an institution on judicial or official order.",{"count":228,"type":20},29,[83,23],"The goal of this Phase I\u002FII, single arm, prospective, open label, dose escalation trial is to assess safety, feasibility and efficacy of ex vivo expanded autologous T cells genetically modified to express a T cell receptor (TCR) specific for dNPM1 peptides restricted to human leukocyte antigen (HLA) A\\*02:01 in patients with relapsed or refractory AML.",[232],"Leukemia, Myeloid, Acute","2026-04-13",{"date":235,"type":64},"2026-04-16",{"date":237,"type":64},"2024-08-01",{"date":239,"type":20},"2028-06",{"name":70,"class":71},{"id":242,"slug":243,"hasResults":11,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":247,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":249,"targetDuration":4,"studyType":21,"phases":250,"briefSummary":251,"conditions":252,"keywords":254,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":262,"locationsCount":193},"100615151","phase-2-daly-ii-japanmb-cart20191-for-dlbcl-100615151","NCT07288879","DALY II Japan\u002FMB-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.","DALY II Japan","Inclusion Criteria:\n\n1. Histologically confirmed DLBCL or associated subtype, defined by WHO 2016 classification:\n\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 Grade 3B)\n2. Relapsed or refractory disease after 2 or more lines of chemotherapy including rituximab and anthracycline and either having failed autologous stem cell transplant (ASCT), or being ineligible for or not consenting to ASCT 2.1 Chemotherapy-refractory disease is defined as one of the following:\n\n   * No response to last line of therapy:\n\n     * Progressive disease (PD) as best response to most recent therapy regimen\n     * Stable disease (SD) as best response to most recent therapy with duration no longer than 6 months from last dose of therapy OR\n   * Relapsed or persistent disease after prior ASCT for lymphoma\n\n     * Disease progression or relapse less than or equal to 24 months of ASCT\n     * If salvage therapy is given post-ASCT, the individual must have had no response to or relapsed after the last line of therapy 2.2 Disease relapse in subjects without prior ASCT is defined as relapse of disease in ≤ 12 months after the last dose of most recent therapy regimen 2.3 Ineligible for ASCT is defined as meeting one of the following criteria:\n   * Chemotherapy-refractory disease after salvage therapy\n   * Disease progression or relapse ≤ 12 months after salvage therapy\n   * Intolerance to salvage therapy\n\n   In addition, all subjects must have:\n3. Age ≥18 years\n4. 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 DLBCL\n5. Measurable disease according to Lugano 2014 criteria for assessing fluorodeoxyglucose-positron emission tomography (FDG-PET)\u002Fcomputer tomography (CT) in lymphoma (Cheson et al, 2014)\n6. CD19 or CD20 antigen expression on tumor is not required after the most recent chemoimmunotherapy; however, 6.1 Subject must have at least 20 unstained slides of tissue available prior to MB-CART2019.1 infusion 6.2 If archival tissue is not available, subject must be willing to undergo attempted repeat biopsy\n7. No clinical suspicion of central nervous system (CNS) lymphoma\n8. If the subject has history of CNS disease, then he\u002Fshe must 8.1. Have no signs or symptoms of CNS disease 8.2. Have no active disease on magnetic resonance imaging (MRI) 8.3. Have no large cell lymphoma present in cerebral spinal fluid (CSF) on cytospin preparation and flow cytometry, regardless of the number of white blood cells (WBCs)\n9. If the subject has history of cerebral vascular accident (CVA) 9.1. The CVA event must be greater than 12 months prior to leukapheresis 9.2. Any neurological deficits must be stable\n10. An estimated creatinine clearance by Cockcroft-Gault Equation (eGFR) \\> 60mL\u002Fmin\n11. Cardiac ejection fraction (EF) ≥ 45% as determined by an echocardiogram (ECHO)\n12. Resting O2 saturation \\>90% on room air\n13. Serum alanine aminotransferase (ALT) \u002F aspartate aminotransferase (AST) \\\u003C5 times the Upper Limit of Normal (ULN) for age\n14. Total bilirubin \\\u003C1.5 mg\u002Fdl, except in individuals with Gilbert's syndrome\n15. Absolute neutrophil count (ANC) \\> 1000\u002FμL\n16. Absolute lymphocyte count \\> 100\u002FμL\n17. Platelet count \\> 50,000\u002FμL\n18. Estimated life expectancy of more than 3 months other than primary disease\n19. 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\n1. Primary CNS lymphoma\n2. Richter's transformed DLBCL arising from chronic lymphocytic leukemia (CLL)\n3. Unable to give informed consent\n4. Known history of infection with human immunodeficiency virus (HIV) or active hepatitis B (HBsAg positive), unless confirmed to be polymerase chain reaction (PCR) negative; antiviral prophylaxis is required as recommended in the Japanese guidelines for Hepatitis B treatment if HBsAg negative and anti-HBc positive\n5. Known history of infection with hepatitis C virus (anti-HCV positive) unless viral load is undetectable per quantitative PCR and\u002For nucleic acid testing\n6. Known history of active seizure or presence of seizure activities or on active anti-seizure medications within the prior 12 months\n7. Known history of CVA within prior 12 months\n8. Known history or presence of autoimmune CNS disease, such as multiple sclerosis, optic neuritis or other immunologic or inflammatory disease\n9. Presence of active CNS disorder that, in the judgment of the investigator, may impair the ability to evaluate neurotoxicity\n10. Active systemic fungal, viral or bacterial infection\n11. Pregnant or breast-feeding woman\n12. Previous or concurrent malignancy with the following exceptions:\n\n    * Adequately treated basal cell or squamous cell carcinoma (adequate wound healing is 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\n13. History of non-neurologic autoimmune disease (e.g. Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) requiring systemic immunosuppressive or systemic disease modifying agents within the last 2 years\n14. Medical condition requiring prolonged use of systemic corticosteroids equivalent to Prednisone \\>10 mg\u002Fday\n15. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 6 months of enrollment\n16. Concurrent radiotherapy (allow up to time of leukapheresis)\n17. Baseline dementia that would interfere with therapy or monitoring, determined using Immune Effector Cell-Associated Encephalopathy (ICE) Assessment at baseline. (Appendix 6, Section 13.6)\n18. History of severe immediate hypersensitivity reaction to any of the agents used in this study\n19. Refusal to participate in additional lentiviral gene therapy LTFU protocol\n20. Prior CAR T cell therapy for any indication\n21. Prior allogeneic stem cell transplant for any indication.\n22. Prior bispecific antibodies for cancer therapy\n23. Prior T cell receptor-engineered T cell therapy\n24. Prior anti CD 19 immunotherapy\n25. Hypersensitivity against any drug including MB-CART2019.1 (and the constituents used in the production, ingredients\u002Fimpurities, including bovine and rodent-derived components), that is scheduled or likely to be given during trial participation, e.g. as part of the mandatory preparative chemotherapy or rescue medication\u002Fsalvage therapies for treatment related toxicities.",{"count":180,"type":20},[23],"DALY II Japan 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.",[253,160],"DLBCL - Diffuse Large B Cell Lymphoma",[255,131],"CAR T Cell therapy","2026-01-06",{"date":258,"type":64},"2026-01-08",{"date":260,"type":64},"2025-12-11",{"date":68,"type":20},{"name":70,"class":71},{"id":264,"slug":265,"hasResults":11,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":269,"eligibilityCriteria":270,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":271,"enrollmentInfo":272,"targetDuration":4,"studyType":21,"phases":274,"briefSummary":276,"conditions":277,"keywords":4,"overallStatus":212,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":4},"100533379","m-2018-334-in-hematological-malignancies-100533379","NCT06225050","M-2018-334 in Hematological Malignancies","A Single-center Pilot Study Using TCRα\u002Fβ and CD45RA Depleted Stem Cell Grafts From Haploidentical Donors for Hematopoietic Cell Transplantation in Adults(HAPLO2022)","HAPLO2022","Inclusion Criteria:\n\n* Patients, between 18 years to 75 years of age, with high-risk hematological malignancy requiring an allogeneic hematopoietic stem cell transplantation (AlloHCT), but do not have an HLA-matched donor available\n\nExclusion Criteria:\n\n* \\\u003C3 months after preceding autologous transplantation or prior AlloHCT\n* History of neurological impairment (active seizures, severe peripheral neuropathy, signs of leukoencephalopathy, active CNS infection)\n* Active fungal infections with radiological and clinical progression\n* Liver function abnormalities with bilirubin \\>2 mg\u002FdL and elevation of transaminases higher than 400 U\u002FL\n* Chronic active viral hepatitis\n* Cardiac dysfunction: adult patients ejection fraction \\\u003C50% on echocardiography\n* Patients with uncontrolled, \\>grade II hypertension (per Common Toxicity Criteria, CTC)\n* Creatinine clearance \\\u003C60 mL\u002Fmin\u002F1.73m2\n* Respiratory failure necessitating supplemental oxygen\n* HIV infection\n* Positive anti-donor HLA antibody\n* Treatment with checkpoint inhibitors in the period between 3 months prior to and 3 months after transplantation\n* Female patients who are pregnant or breast feeding, or adults of reproductive potential not willing to use an effective method of birth control during study treatment and for at least 12 months thereafter. Note: Women of childbearing potential must have a negative serum pregnancy test at study entry\n* Concurrent severe or uncontrolled medical disease (e.g., uncontrolled diabetes, myocardial infarction within 6 months prior to the study) which by assessment of the treating physician could compromise participation in the study\n* Patients with a history of psychiatric illness or a condition which could interfere with their ability to understand the requirements of the study (this includes alcoholism\u002Fdrug addiction).\n* Patients unwilling or unable to comply with the protocol or unable to give informed consent\n* Treatment with any investigational product within 4 weeks prior to study treatment","75 Years",{"count":273,"type":20},18,[275],"NA","This is a single-center, open-label, single-arm, pilot clinical study using TCRα\u002Fβ and CD45RA depleted stem cell grafts from haploidentical donors for hematopoietic cell transplantation in 12 to 18 adult patients.",[278],"Hematological Malignancies","2025-11-25",{"date":281,"type":64},"2025-12-03",{"date":283,"type":20},"2026-02-28",{"date":285,"type":20},"2029-02-28",{"name":70,"class":71},{"id":288,"slug":289,"hasResults":11,"nctId":290,"briefTitle":291,"officialTitle":291,"acronym":292,"eligibilityCriteria":293,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":21,"phases":296,"briefSummary":297,"conditions":298,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":314},"100555183","long-term-follow-up-of-patients-treated-with-miltenyi-cell-and-gene-therapies-100555183","NCT06508775","Long-Term Follow-up of Patients Treated With Miltenyi Cell and Gene Therapies","LONGSAFE","Inclusion Criteria:\n\n* Patient underwent treatment with a Miltenyi CAR T cell therapy in one of the parent trials at least 12 months prior to enrollment in long-term follow-up.\n* Patient has provided informed consent prior to enrollment.\n\nExclusion Criteria:\n\n* No exclusion criteria",{"count":295,"type":20},40,[275],"The goal of this Long-Term Follow-Up Trial is to assess long-term safety and efficacy of Miltenyi CAR T treatment.",[299,300,301,302,303,304,305],"Melanoma Stage III","B-cell Non Hodgkin Lymphoma","Pediatric ALL","Childhood Non-Hodgkin Lymphoma","Acute Lymphatic Leukemia","Chronic Lymphatic Leukemia","Melanoma Stage IV","2025-11-20",{"date":308,"type":64},"2025-11-26",{"date":310,"type":64},"2024-05-05",{"date":312,"type":20},"2040-12-31",{"name":70,"class":71},7,{"id":316,"slug":317,"hasResults":11,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":4,"eligibilityCriteria":321,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":322,"targetDuration":4,"studyType":21,"phases":323,"briefSummary":324,"conditions":325,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":327,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"locationsCount":333},"100530621","phase-1-mb-cart191-in-refractory-sle-100530621","NCT06189157","MB-CART19.1 in Refractory SLE","An Open-label Phase I\u002FIIa, Multicentre, Interventional Single-arm Trial of MB-CART19.1 in Patients With Refractory SLE","Inclusion Criteria:\n\n1. Patients at least 18 years of age.\n2. Signed and dated informed consent before the conduct of any trial-specific procedure.\n3. SLE fulfilling the 2019 ACR\u002FEULAR classification criteria (refer to Appendix 8).\n4. One BILAG A or two BILAG B despite treatment with at least two of the following treatment options: MMF, cyclophosphamide, rituximab belimumab, anifrolumab, methotrexate, azathioprine.\n5. SLE with major organ involvement defined as either:\n\n   1. Presence of active lupus nephritis according to the following criteria:\n\n      * Histology proven class III or IV lupus nephritis according to ISN\u002FRPS 2003 classification\n      * Urine protein-to-creatinine ratio (UPCR) \\>1 in 24-hour urine collection\n      * Glomerular filtration rate (eGFR) of ≥30 mL\u002Fmin\u002F1.73 m2\n      * No history of kidney transplantation.\n   2. Lupus with heart involvement (e.g., myocarditis, pericarditis, endocarditis) as measured by MRI or echocardiography\u002Fultrasound.\n   3. Lupus with pulmonary involvement (Lupus pleuritis, pulmonary arterial hypertension (PAH)) or lung disease defined as:\n\n      * Forced Vital Capacity (FVC) ≥ 60 % OR\n      * Forced Expiratory Volume (FEV1) ≥ 60 %,Total Lung Capacity (TLC) ≥ 60 %, DLCO (diffusion capacity) ≥ 60 % (according to ATS\u002FERS guidelines).\n6. Absolute CD3+ T cell count ≥ 100\u002Fµl.\n7. No childbearing potential or negative pregnancy test at screening and before chemotherapy in women with childbearing potential. Subjects must agree to use a contraceptive method from screening until 12 months after the administration of the IMP.\n8. Fully vaccinated against SARS-CoV-2 according to the recommendations of RKI or confirmed SARS-CoV-2 infection within the last 6 months.\n\nExclusion Criteria:\n\n1. Active clinically significant central nervous system (CNS) dysfunction (including but not limited to uncontrolled seizure disorders, cerebrovascular ischemia or hemorrhage, dementia, paralysis).\n2. Uncontrolled diabetes mellitus.\n3. Therapy induced lung disease and tuberculosis.\n4. Forced Vital Capacity (FVC) \\\u003C 60 %, FEV1 \\\u003C 60 %, Total Lung Capacity (TLC) \\\u003C 60 % and DLCO (diffusion capacity) \\\u003C 60 %.\n5. BILAG A or BILAG B for neuropsychiatric SLE.\n6. History of a malignancy unless disease free for ≥ 5 years with the exception of basal or squamous cell skin cancer.\n7. Cardiac function: Unstable coronary heart disease; left ventricular ejection fraction (LVEF) \\\u003C 50 %; no active myocarditis.\n8. Renal function: eGFR \\\u003C 30 ml\u002Fmin\u002F1.73 m2.\n9. Liver function: Severe hepatic insufficiency defined as a Child-Pugh score \\> 10(C) (Appendix 10).\n10. Known history of infection with human immunodeficiency virus or active infection with hepatitis B (hepatitis B surface antigen positive).\n11. Known history of infection with hepatitis C virus unless treated and confirmed to be polymerase chain reaction (PCR) negative.\n12. Any active, uncontrolled bacterial, viral or fungal infection including SARS-CoV-2.\n13. History of hematopoietic stem cell or solid organ transplantation.\n14. Irreversible organ damage.\n15. Medications:\n\n    * Systemic corticosteroids \\>10 mg within 7 days prior to leukapheresis;\n    * T cell targeting drugs (e.g., mycophenolate mofetil, calcineurin inhibitors) within 21 days prior to leukapheresis;\n    * Prior treatment with anti-CD19 therapy;\n    * Previous adoptive T cell therapy or any gene therapy including CAR T cell therapy;\n    * Live vaccines within 30 days prior to leukapheresis;\n    * Current cytotoxic drugs.\n16. Hypersensitivity against any drug or its ingredients\u002Fimpurities that is scheduled or likely to be given during trial participation, e.g., as part of the mandatory preparative chemotherapy or rescue medication\u002Fsalvage therapies for treatment related toxicities.\n17. Contraindication of trial related procedures as judged by the investigator.\n18. Women of childbearing potential (WOCBP) who do not agree to use highly effective contraceptive measures (Pearl index \\\u003C 1) or practice true sexual abstinence from any heterosexual intercourse (true abstinence is only acceptable if it is in line with the preferred and usual life style of the participant) or have a vasectomised partner as the sole sexual partner (the vasectomised partner must have received medical assessment of the surgical success) for at least 1 month before the study start, during the study and in the 12 months following the last dose of study treatment.\n\n    A woman is considered a WOCBP, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. WOCBP who want to become pregnant after completing treatment should seek advice about oocyte cryoconservation prior to treatment because of possible irreversible infertility. WOCBP must refrain from egg donation throughout the study until 12 months after the last dose of study treatment.\n\n    Highly effective methods of contraception include hormonal contraceptives associated with inhibition of ovulation (oral, intravaginal, transdermal, injectable, implantable) and intrauterine devices or systems (e.g. hormonal and non-hormonal) and bilateral tubal occlusion.\n\n    Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.\n\n    A post-menopausal state is defined as no menses for 12 months without an alternative medical cause.\n19. Men with non-pregnant WOCBP partners who do not agree to use highly effective contraceptive measures (Pearl index \\\u003C 1, e.g. spermicide and condom or other highly effective contraceptive measures (Pearl index \\\u003C 1) taken by their WOCBP partner) or practice true sexual abstinence from any heterosexual intercourse (true abstinence is only acceptable if it is in line with the preferred and usual life style of the participant.), unless they are surgically sterile (meaning at least 2 consecutive analyses following vasectomy demonstrate absence of sperms in the ejaculate), during the study and in the 12 months following the last dose of study treatment.\n\n    Men should seek advice about sperm conservation prior to treatment because of possible irreversible infertility. Men must furthermore refrain from sperm donation throughout the study until 12 months after the last administration of study treatment.\n20. Concurrent participation in any other interventional trial.\n21. Inability to understand the procedures and risks associated with the trial.",{"count":228,"type":20},[83,23],"This is a phase l\u002Fll open-label, multicentre, interventional single-arm trial of MB-CART19.1 in patients with refractory SLE systemic lupus erythematosus. In the phase I part, a maximum of n=12 patients will be treated in a maximum of 3 dose levels.\n\nIn the phase IIa part, a maximum of n=17 will be treated (n=10 patients in a 1st stage + n=7 patients in a 2nd stage). This includes the patients from the phase I part treated on the recommended dose level.",[326],"SLE - Systemic Lupus Erythematosus",{"date":308,"type":64},{"date":329,"type":64},"2024-08-12",{"date":331,"type":20},"2027-09-30",{"name":70,"class":71},3,{"id":335,"slug":336,"hasResults":11,"nctId":337,"briefTitle":338,"officialTitle":338,"acronym":339,"eligibilityCriteria":340,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":341,"targetDuration":4,"studyType":21,"phases":343,"briefSummary":344,"conditions":345,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":108},"100542811","phase-1-car-t-cells-in-systemic-b-cell-mediated-autoimmune-disease-100542811","NCT06347718","CAR-T Cells in Systemic B Cell Mediated Autoimmune Disease","CASTLE","Inclusion Criteria:\n\n* General:\n\n  * Subjects must understand and voluntarily sign an informed consent form including written consent for data protection,\n  * Adults aged ≥ 18 years at time of consent,\n  * Adequate renal (eGFR \\> 30 ml\u002Fmin\u002Fm2), liver (no Child Pugh C), heart (at worst NYHA III, EF \\> 30%) and pulmonary (FV and DLCO \\> 30%) function,\n  * Male subjects unless surgically sterile, must agree to use two acceptable methods for contraception (e.g. spermicide and condom) during the trial and refrain from fathering a child starting from the time of signing the Informed Consent Form (ICF) until 12 months after dosing of the IMP,\n  * Females of childbearing potential (FCBP) must have a negative urine pregnancy test at screening and must agree to use a highly effective contraceptive method (Pearl in-dex \\\u003C1) starting from the time of signing the ICF and for 12 months after dosing of the IMP,\n  * Must be able to adhere to the study visit schedule and other protocol requirements,\n  * Double vaccination against SARS-CoV-2 or SARS-CoV-2 within the last 6 months.\n* SLE specific:\n\n  * Fulfilling the 2019 ACR\u002FEULAR classification criteria of SLE,\n  * Positivity of anti-dsDNA (\\> 4 U\u002Fl), anti-histone (+ or more), anti-nucleosome (+ or more) or anti-Sm antibodies (+ or more),\n  * Active disease at screening, defined as ≥ 1 organ system with a British Isles Lupus Assessment (BILAG) A score (severe disease activity) or ≥ 2 organ systems with a BILAG B score (moderate disease activity),\n  * Insufficient response or intolerance\u002F contraindication to glucocorticoids and to at least 2 of the following treatments: hydroxychloroquine, mycophenolate mofetil, belimumab, methotrexate, rituximab, cyclophosphamide. Insufficient response is defined as having increased disease activity based on the definition explained in the previous bullet point.\n* SSc specific:\n\n  * Fulfilling the 2013 ACR\u002FEULAR classification criteria of SSc),\n  * Positivity (+ or more) for at least one SSc-specific parameter (Scl70, RNA polymerase, Th\u002FTo, RP11\u002F12, U3RNP autoantibodies),\n  * Signs for fast progression including (i) disease duration ≤ 5 years (from onset of first non-Raynaud manifestation), (ii) mRSS score 10-35 at screening, (iii) elevated acute phase reactant levels (CRP ≥ 6 mg\u002FL, ESR ≥ 28mm\u002Fh or platelet count ≥ 330 G\u002FL), (iii) mRSS increase ≥ 3 units or involvement of one new body area or mRSS increase ≥ 2 units in one body area or ≥ 1 tendon friction rub over 6 months,\n  * Insufficient response or intolerance\u002F contraindication to at least 2 of the following treatments: mycophenolate mofetil, azathioprine, nintedanib, methotrexate, rituximab. Insufficient response is defined as having increased disease activity based on the definition explained in the previous bullet point.\n* DM\u002FPM specific:\n\n  * Fulfilling the 2017 ACR\u002FEULAR classification criteria for probable or definite DM or PM,\n  * Presence of active myositis in muscle biopsy or muscle MRI and\u002For signs of interstitial lung disease related to DM\u002FPM,\n  * Positivity (+ or more) for at least one myositis-specific antibody (aminoacyl tRNA synthetases, Mi2, MDA5, SAE, SRP, ARS, HMGCR, MJ, TIF1gamma),\n  * Muscle weakness as define by MMT \\\u003C 142 and 2 of the following criteria: VAS patients Global ≥2cm, VAS physician Global ≥ 2cm, HAQ \\> 0.25, at least one muscle enzyme \\> 1.3 times upper limit of normal, VAS global extra muscular activity ≥ 2cm,\n  * Insufficient response or intolerance\u002F contraindication to glucocorticoids and to at least 2 of the following treatments: mycophenolate mofetil, ciclosporin A, tacrolimus, methotrexate, rituximab, intravenous immunoglobulins. Insufficient response is defined as having increased disease activity based on the definition explained in the previous bullet point.\n\nExclusion Criteria:\n\n* Clinically suitability for a less burdensome and\u002For approved therapeutic approach, as judged by the investigator\n* ANC \\\u003C 1.000\u002Fmm3, ALC \\\u003C 500\u002Fmm3 or hemoglobin \\\u003C 8g\u002Fdl, absolute CD3+ T cell count \\\u003C 100\u002Fμl,\n* Uncontrolled severe concomitant disease, such as cancer (except basal or squamous cell skin cancer) and diabetes mellitus,\n* Severely impaired renal (eGFR ≤ 30 ml\u002Fmin\u002Fm2), liver (Child Pugh C), heart (NYHA IV, EF ≤ 30%) and pulmonary (FV and DLCO ≤ 30%) function,\n* Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if the subject were to participate in the study or confounds the ability to interpret data from the study,\n* Prior treatment with anti-CD19 antibody therapy, adoptive T cell therapy or any prior gene therapy product (e.g. CAR T cell therapy),\n* History of bone marrow\u002F hematopoietic stem cell or solid organ transplantation,\n* Any concomitant severe active infection, e.g. HIV, hepatitis B or C, SARS-CoV 2 (COVID 19), or active tuberculosis as defined by a positive Quantiferon TB-test. If presence of latent tuberculosis is established then treatment according to local guidelines must have been initiated prior to enrollment,\n* Diagnosis of severe neuropsychiatric SLE, inclusion body myositis or limited SSc,\n* Pregnant or lactating females,\n* Females who are intending to conceive during the study,\n* Known hypersensitivity to any drug components,\n* Malignancy in the last 5 years before screening,\n* Requirement for immunization with live vaccine during the study period or within 14 days preceding leukapheresis,\n* Subjects who are younger than 18 years or are incapable to understand the aim, importance and consequences of the study and to give legal informed consent,\n* Have a history of alcohol or substance abuse within the preceding 6 months that, in the opinion of the Investigator, may increase the risks associated with study participation or study agent administration, or may interfere with interpretation of results,\n* Subjects who possibly are dependent on the Sponsor, the Principal Investigator or other Investigators (e.g. family members).",{"count":342,"type":20},24,[83,23],"The investigational product is designed to effectively combat B cells in patients with autoimmune diseases. Autologous T cells enriched with CD4\u002FCD8 are genetically engineered using a lentiviral vector to express chimeric antigen receptors (CARs) that target the CD19 antigen on the cell surface of B cells and their precursors. During treatment, patients undergo leukapheresis, lymophodepleting chemotherapy and administration of the expanded CD19-CAR-transduced T cells.",[87,346,347,348],"Systemic Sclerosis","Dermatomyositis","Polymyositis","2025-09-24",{"date":351,"type":64},"2025-09-30",{"date":353,"type":64},"2023-07-17",{"date":355,"type":20},"2026-05-31",{"name":70,"class":71},{"id":358,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":360,"targetDuration":4,"studyType":21,"phases":362,"briefSummary":363,"conditions":364,"keywords":365,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":369,"completionDateStruct":370,"leadSponsor":371,"locationsCount":372},"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":361,"type":20},248,[23],"DALY II USA is a phase II, multi-center, single arm study to evaluate the efficacy, safety, and pharmacokinetics of zamtocabtagene autoleucel (MB-CART2019.1) in patients with relapsed and\u002For refractory diffuse large B cell lymphoma (DLBCL) after receiving at least two lines of therapy. Additional cohorts include subjects with B-cell primary or secondary central nervous system (CNS) lymphoma (PCNSL) and (SCNSL), mantle cell lymphoma (MCL) and Richter's transformation (RT) after receiving at least one line of therapy.",[26,27,28,29,30,31,32,33],[36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58],"2025-04-21",{"date":368,"type":64},"2025-04-24",{"date":66,"type":64},{"date":68,"type":20},{"name":70,"class":71},25,{"id":374,"slug":375,"hasResults":11,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":4,"eligibilityCriteria":379,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":380,"targetDuration":4,"studyType":382,"phases":4,"briefSummary":383,"conditions":384,"keywords":386,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":193},"100525005","lentiviral-gene-therapy-zamtocabtagene-autoleucel-ltfu-100525005","NCT06116110","Lentiviral Gene Therapy (Zamtocabtagene Autoleucel) LTFU","A Prospective, Observational, Long-term Follow-up Study for Subjects Who Previously Received Zamtocabtagene Autoleucel in a United States Miltenyi Biomedicine-Sponsored Clinical Study","Inclusion Criteria:\n\n* Received zamtocabtagene autoleucel in a Miltenyi Biomedicine-sponsored clinical study and have either completed the study or have discontinued early from the study.\n* Provided written informed consent to participate in this study.\n\nExclusion Criteria:\n\n* None",{"count":381,"type":20},150,"OBSERVATIONAL","This is an observational long-term follow-up (LTFU) study for subjects who previously received zamtocabtagene autoleucel, known as MB-CART2019.1.",[385],"Non Hodgkin Lymphoma",[91,92,129,128],"2024-11-18",{"date":389,"type":64},"2024-11-20",{"date":391,"type":64},"2024-05-15",{"date":393,"type":20},"2039-12-01",{"name":70,"class":71},""]