[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lymphoblastic-leukemia-acute-adult\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lymphoblastic-leukemia-acute-adult":21},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,38,77,109],{"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":4,"targetDuration":4,"studyType":18,"phases":4,"briefSummary":19,"conditions":20,"keywords":23,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":34,"locationsCount":37},"100577509","expanded-access-program-for-oos-obe-cel-100577509",false,"NCT06799221","Expanded Access Program for OOS Obe-cel","Expanded Access Program (EAP) for Obecabtagene Autoleucel (Obe-cel) Out-of-specification (OOS) in Adult Patients With Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* Patient (or legally authorized representative) is willing to provide informed consent.\n* Patient must be 18 years of age or older.\n* Patient must have a confirmed diagnosis of relapsed\u002Frefractory B cell ALL.\n* Commercial obe-cel was indicated to the patient by their treating physician as per standard of care prior to leukapheresis.\n* The final manufactured obe-cel does not meet the commercial release specifications.\n* The final manufactured obe-cel is acceptable per joint assessment by Autolus and physician taking into account Autolus' release criteria.\n* Remanufacturing (i.e., repeat leukapheresis and manufacturing) is not clinically appropriate per the treating physician's assessment.\n* Patient deemed medically fit and stable to receive obe-cel infusions per their treating physician's evaluation.\n* For females of childbearing potential (defined as \\\u003C 24 months after last menstruation or not surgically sterile), a negative serum or urine pregnancy test must be documented at screening, prior to lymphodepletion therapy and confirmed before receiving the first dose of study treatment.\n* For females who are not postmenopausal (\\\u003C 24 months of amenorrhea) or who are not surgically sterile (absence of ovaries and\u002For uterus), 2 methods of contraception comprising 1 highly effective method of contraception together with a barrier method must be used during the treatment period and for at least 12 months after the last dose of study treatment. They must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 12 months after receiving the last dose of study drug.\n* For males, it must be agreed that 2 acceptable methods of contraception are used (1 by the patient - usually a barrier method, and 1 highly effective method by the patient's partner) during the treatment period and for at least 12 months after the last dose of study treatment and that sperm will not be donated during the treatment period and for at least 12 months after the last dose of study treatment.\n\nExclusion Criteria:\n\n* History of severe immediate hypersensitivity to any drugs or metabolites of similar chemical classes as obe-cel.\n* Pregnant women.\n* Active participation in an interventional trial.","ALL","18 Years","EXPANDED_ACCESS","The purpose of this program is to provide access to obe-cel treatment for adult patients with ALL who have undergone leukapheresis and had obe-cel manufactured from their blood cells but the product is deemed OOS (does not meet the specifications to be used commercially). The target patients for this study have limited options for treatment and repeat blood sampling is not feasible. The main aims of this study are (1) to provide adult patients with ALL with access to obe-cel and (2) to describe the safety profile of obe-cel (including CRS, ICANS, serious infections, secondary cancers, and any side effects) within the first 45 days after infusion of OOS obe-cel.\n\nThis study is a single-arm, open-label, multicenter expanded access program (EAP). The patient population included in this EAP will be adult patients diagnosed with recurring or refractory ALL who were prescribed obe-cel as part of their standard of care and are eligible for use under the approved local prescribing information.\n\nTo be in the study, patients must provide informed consent, be at least 18 years of age, have a confirmed diagnosis of ALL, be medically fit and stable to receive obe-cel, have had commercial obe-cel prescribed by their treating physician as per standard of care, and for whom remanufacturing is not clinically appropriate.\n\nPatients cannot be in the study if they have a history of severe immediate allergic reaction to any drugs or metabolites of similar chemical classes as obe-cel, are a pregnant woman, or are receiving treatment in another study.\n\nAll data will be collected from information routinely recorded in the medical record. There is no formal hypothesis testing. Data will be analyzed descriptively (numbers, percentages and ranges, etc.).",[21,22],"Lymphoblastic Leukemia, Acute, Adult","B Cell ALL",[24,25,26,27,28],"Relapsed B cell acute lymphoblastic leukemia","Refractory B cell acute lymphoblastic leukemia","Adult acute lymphoblastic leukemia","Obecabtagene autoleucel (obe-cel)","Obe-cel","AVAILABLE","2026-02-25",{"date":32,"type":33},"2026-02-27","ACTUAL",{"name":35,"class":36},"Autolus Limited","INDUSTRY",32,{"id":39,"slug":40,"hasResults":11,"nctId":41,"briefTitle":42,"officialTitle":42,"acronym":4,"eligibilityCriteria":43,"healthyVolunteers":11,"sex":16,"minAge":44,"maxAge":45,"enrollmentInfo":46,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":60,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100489046","phase-2-cd19-directed-chimeric-antigen-receptor-car-t-cell-therapy-for-relapsedrefractory-b-lineage-leukaemia--lymphoma---a-feasibility-protocol-100489046","NCT05648019","CD19-Directed Chimeric Antigen Receptor (CAR) T-Cell Therapy for Relapsed\u002FRefractory B-Lineage Leukaemia \u002F Lymphoma - A Feasibility Protocol","Inclusion Criteria:\n\n1. Eligible disease conditions:\n\n   1. Relapsed or refractory B-cell ALL (all must be satisfied)\n\n      * Presence of lymphoblasts in bone marrow aspirate by morphologic assessment or positive minimal residual disease at screening.\n      * Relapsed or refractory or ineligible for HSCT\n      * For relapsed B-ALL: Documentation of CD19 tumour expression (e.g. by flow cytometry) demonstrated in bone marrow or peripheral blood within 3 months of study entry\n   2. Relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.\n2. Age at screening:\n\n   1. \\\u003C 18 years (paediatric group); or\n   2. ≥ 18 years (adult group)\n3. Adequate organ functions:\n4. Life expectancy more than 12 weeks.\n5. Karnofsky (age ≥ 16 years) or Lansky (age \\\u003C 16 years) performance status ≥ 50 at screening.\n6. Must meet the institutional criteria to undergo leukapheresis or have a leukapheresis product of non-mobilized cells received and accepted by the manufacturing site.\n\nExclusion Criteria:\n\nPatients with any of the following will be excluded:\n\n* B-ALL with isolated extramedullary disease relapse\n* Patients with concomitant genetic syndrome: such as patients with Fanconi anaemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. Patients with Down syndrome will not be excluded.\n* Patients with Burkitt's lymphoma\u002Fleukaemia (i.e. patients with mature B-cell ALL; leukaemia with B-cell \\[sIg positive and kappa or lambda restricted positivity\\] ALL, with FAB L3 morphology and \u002For a MYC translocation)\n* Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening\n* Human Immunodeficiency Virus (HIV) positive test within 8 weeks of screening\n* Presence of grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD)\n* Active CNS involvement by malignancy, defined by CNS-3 per NCCN guidelines. Subjects with CNS-2 involvement or with history of CNS disease that have been actively treated are eligible.\n* Patient has an investigational medicinal product within the last 30 days prior to screening.\n* Pregnant or nursing women.\n* Women of childbearing potential (defined as all women physiologically capable of becoming pregnant) and all male participants, unless they are using highly effective methods of contraception for a period of 1 year after the CAR T-cell infusion. All female patients of childbearing potential must have a negative pregnancy test performed within 48 hours before infusion of CAR T-cells.\n\nThe following are not strictly exclusion criteria but must be discussed with PI\u002FSite-PI:\n\n* Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease\n* Treatment with any prior gene therapy product\n* Has had treatment with any prior anti-CD19\u002Fanti-CD3 therapy, or any other anti-CD19 therapy","0 Years","70 Years",{"count":47,"type":48},40,"ESTIMATED","INTERVENTIONAL",[51],"PHASE2","The purpose of this study is to describe feasibility of delivering point-of-care manufactured CD19-directed CAR T-cell therapy to patients with relapsed\u002F refractory B-lineage leukaemia\u002F lymphoma.",[54,55,56,57,58,59],"Lymphoblastic Leukemia","Lymphoblastic Leukemia in Children","Lymphoblastic Leukemia, Acute Adult","B-cell Acute Lymphoblastic Leukemia","Large B-cell Lymphoma","CAR",[61,62,63,64],"CAR T-cell therapy","Relapse\u002FRefractory","B-ALL","B-Lineage Lymphoma","RECRUITING","2023-03-07",{"date":68,"type":33},"2023-03-09",{"date":70,"type":33},"2022-03-15",{"date":72,"type":48},"2026-12",{"name":74,"class":75},"KK Women's and Children's Hospital","OTHER_GOV",2,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":49,"phases":88,"briefSummary":90,"conditions":91,"keywords":95,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":108},"100442606","phase-1-cartall-chimeric-antigen-receptor-car-t-cell-therapy-for-relapsed-refractory-t-lineage-acute-lymphoblastic-leukaemia-100442606","NCT05043571","CARTALL: Chimeric-Antigen Receptor (CAR) T-Cell Therapy for Relapsed\u002F Refractory T-Lineage Acute Lymphoblastic Leukaemia","Anti-CD7 Protein Expression Blocker (PEBL) Chimeric-Antigen Receptor (CAR) T-Cell Therapy for Relapsed\u002F Refractory T-Lineage Acute Lymphoblastic Leukaemia (CARTALL)","Inclusion Criteria:\n\n* Diagnosis\u002F Disease define as:\n\n  1. Relapsed T-cell acute lymphoblastic leukaemia\u002F lymphoma as defined by:\n\n     Bone marrow disease = or \\> 0.01% by MRD as determined by flow cytometry\n\n     Or CNS disease as defined as \\> 5 WBCs\u002F uL in CSF with morphological evidence of blasts or biopsy proven recurrence in the eye or brain\n\n     Or Extramedullary relapse as defined by morphological evidence of blasts in the testis or any other extramedullary sites\n  2. Induction failure as defined by:\n\n     MRD = or \\> 1% by flow cytometry at the end of induction on day 33\n\n     Or Failure to achieve morphological remission defined as \\> 5% blasts after standard induction chemotherapy\n  3. Refractory disease as defined by:\n\n     MRD = or \\> 0.01% by flow cytometry or molecular methods during 2 or more timepoints after induction therapy\n* Minimum level of pulmonary reserve defined as Grade ≤ 1 dyspnoea and oxygen saturation (SpO2) of \\> 95% on room air\n* Left ventricular systolic function (LVSF) ≥ 28% confirmed by echocardiogram, or left ventricular ejection fraction (LVEF) ≥ 45% confirmed by echocardiogram within 3 months of screening\n* Karnofsky (age ≥ 16 years) or Lansky (age \\\u003C 16 years) performance status ≥ 50 at screening\n* Normal Age-adjusted eGFR Creatinine Clearance within 3 months of screening\n* Alanine aminotransferase ≤ 5 times the upper limit of normal for age\n* Patients with \\> 99% CD7 expression on blast cells will be eligible for anti-CD7 PEBL-CAR-T cell infusion.\n\nExclusion Criteria:\n\n* Failure to meet any of the inclusion criteria\n* Patients who test positive on urine pregnancy testing and are pregnant or are lactating\n* Concomitant genetic syndromes associated with bone marrow failure states, such as Fanconi anaemia, Kostmann syndrome, Schwachman syndrome, or any other bone marrow failure syndrome with the exception of Down syndrome\n* Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and no evidence of active disease\n* Active or latent hepatitis B or hepatitis C infections within 8 weeks of screening, or any uncontrolled infection at screening\n* Positive Human Immunodeficiency Virus (HIV) test within 8 weeks of screening\n* Grade 2 to 4 acute graft-vs-host disease (GVHD) or extensive chronic GVHD\n* Received an investigational medicinal product within 30 days of screening\n* Central nervous system : Uncontrolled seizures or status epilepticus; increased intra-cranial pressure as evidenced by papilledema and CSF opening pressure \\> 20 cm water; decreased conscious state (any cause)","6 Months","65 Years",{"count":87,"type":48},20,[89],"PHASE1","The objective of this study is to assess the safety and efficacy of anti-CD7 CAR T-cells in patients with refractory or relapsed T-lineage acute lymphoblastic leukemia (T-ALL).",[92,54,56,55,59,93,94],"Lymphoblastic Leukemia, Acute, Childhood","CAR T-Cell-Related Encephalopathy Syndrome","Refractory Leukemia",[96,97,61],"T-ALL","CAR-T cell therapy","2021-09-07",{"date":100,"type":33},"2021-09-14",{"date":102,"type":48},"2021-09-08",{"date":104,"type":48},"2026-11-01",{"name":106,"class":107},"National University Hospital, Singapore","OTHER",1,{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":16,"minAge":84,"maxAge":117,"enrollmentInfo":118,"targetDuration":4,"studyType":49,"phases":119,"briefSummary":120,"conditions":121,"keywords":122,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":108},"100442231","phase-1-alacart-b-acute-leukemia-and-chimeric-antigen-receptor-t-cell-therapy-for-b-lymphoblastic-leukemia-100442231","NCT05038696","ALaCART-B: Acute Leukemia and Chimeric Antigen Receptor-T Cell Therapy for B-lymphoblastic Leukemia.","Chimeric-Antigen Receptor (CAR) T-Cell Therapy Using Multiple CARs and Cell Marker Profiling in High Risk and Relapsed\u002F Refractory B-Lineage Acute Lymphoblastic Leukaemia","ALaCART","Inclusion Criteria:\n\n* Fulfil the Diagnosis\u002F Disease define as:\n\n  1. Relapsed B-cell acute lymphoblastic leukaemia\u002F lymphoma as defined by:\n\n     Bone marrow disease = or \\> 0.01% by MRD as determined by flow cytometry Or CNS disease as defined as \\> 5 WBCs in CSF by morphology, or flow cytometric or molecular evidence of blasts or biopsy proven recurrence in the eye or brain.\n\n     Or Extramedullary relapse as defined by morphological evidence of blasts in the testis or any other extramedullary sites\n  2. Induction failure as defined by Day 33\u002F End of induction:\n\n     MRD ≥ 1% by flow cytometry on the Ma-Spore ALL 2020 protocol Or Failure to achieve morphological remission defined as \\> 5% blasts after standard induction chemotherapy\n  3. Refractory disease as defined by:\n\n     MRD ≥ 0.01% by flow cytometry or molecular methods during 2 or more timepoints after induction therapy\n  4. Any high risk features including :\n\n     BCR-ABL1, BCR-ABL1-like, - ABL1-r, PDGFRB-r, TCF3-HLF, MLL-r, hypodiploid ALL (\\\u003C 45 chromosomes), p53 pathogenic mutation as defined by RNA Seq or other molecular methods.\n  5. Patients who are unable to tolerate standard chemotherapy due to significant toxicity as well as other comorbidities\n* Minimum level of pulmonary reserve defined as grade ≤ 1 dyspnoea and oxygen saturation of \\> 95% on room air\n* Left ventricular systolic function ≥ 28% confirmed by echocardiogram, or left ventricular ejection fraction ≥ 45% confirmed by echocardiogram within 3 months of screening\n* Karnofsky (age ≥ 16 years) or Lansky (age \\\u003C 16 years) performance status ≥ 50 at screening\n* Normal Age-adjusted eGFR Creatinine Clearance within 3 months of screening\n* Alanine aminotransferase ≤ 5 times the upper limit of normal for age\n* Patients with \\> 99.9% of CD19 expression on blast cells will be eligible for anti-CD19 CAR T-cell infusion.\n* Patients with partial or absent CD19 expression (\\\u003C 99.9%) on blast cells will be eligible to receive combinations of other CAR T-cells depending on the pattern of antigen expression.\n\nExclusion Criteria:\n\n* Failure to meet any of the inclusion criteria.\n* Patients who test positive on urine pregnancy testing and are pregnant or are lactating\n* Concomitant genetic syndromes associated with BM failure states, such as Fanconi anaemia, Kostmann syndrome, Schwachman syndrome, or any other BM failure syndrome with the exception of Down syndrome\n* Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and no evidence of active disease\n* Active or latent hepatitis B or active hepatitis C within 8 weeks of screening, or any uncontrolled infection at screening\n* Positive HIV test within 8 weeks of screening\n* Grade 2 to 4 acute graft-vs-host disease (GVHD) or extensive chronic GVHD\n* Received an investigational medicinal product within 30 days of screening\n* Persistent disease or relapse after other forms of CAR-T cell therapy.","80 Years",{"count":47,"type":48},[89],"The objective of this study is to assess the safety and efficacy of a immunophenotype-adapted approach using CAR T-cells in patients with high-risk, refractory or relapsed B-lineage acute lymphoblastic leukemia (B-ALL).",[92,54,56,55,59,93],[63,97,61],{"date":124,"type":33},"2021-09-09",{"date":126,"type":33},"2021-04-28",{"date":128,"type":48},"2026-08-01",{"name":106,"class":107}]