[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"car\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:car":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,42,84,118,146],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100614724","early-phase-1-exploratory-clinical-study-of-second-generation-cd19bcma-chimeric-antigen-receptor-nk-cell-injection-in-treating-paediatric-b-cell-related-autoimmune-diseases-100614724",false,"NCT07283315","Exploratory Clinical Study of Second-generation CD19\u002FBCMA Chimeric Antigen Receptor NK Cell Injection in Treating Paediatric B Cell-related Autoimmune Diseases","Exploratory Clinical Study on the Safety and Efficacy of Second-generation CD19\u002FBCMA Chimeric Antigen Receptor NK Cell Injection in Treating Paediatric B Cell-related Autoimmune Diseases","Inclusion Criteria:\n\n* Common Inclusion Criteria:\n\n  1. Informed consent: The participant (and guardian if the participant is a minor) must provide written informed consent, indicating understanding of the study purpose and procedures and willingness to participate.\n  2. Cardiac Function: Echocardiography shows no significant structural abnormalities and left ventricular ejection fraction (LVEF) ≥ 55%.\n  3. Hepatic Function: ALT ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); AST ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); Total bilirubin ≤ 2.0 × ULN (≤ 3.0 × ULN allowed for Gilbert syndrome).\n  4. Renal Function: eGFR ≥ 30 mL\u002Fmin\u002F1.73 m².(Participants with eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m² and\u002For those receiving renal replacement therapy may be considered eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant or guardian provides fully informed consent.)\n  5. Pulmonary Function: No severe pulmonary disease, and SpO₂ ≥ 92%.\n  6. Women of childbearing potential must use medically acceptable contraception or practice abstinence during the study treatment period and for at least 12 months after the end of study treatment.\n\nDisease-Specific Inclusion Criteria\n\nSLE:\n\n1. Age ≥ 5 years.\n2. Meets the 2012 SLICC or 2019 EULAR\u002FACR classification criteria for SLE.\n3. Must meet at least one of the following adequate treatment conditions:\n\n   1. Treated with glucocorticoids (≥1 mg\u002Fkg\u002Fday prednisone or equivalent) plus one or more immunomodulatory agents (including cyclophosphamide, MMF, azathioprine, methotrexate, cyclosporine, tacrolimus, sirolimus, leflunomide, thalidomide, belimumab, or rituximab) for at least 3 months.\n   2. Patients unable to tolerate conventional therapy may be eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant (or guardian if minor) provides fully informed consent.\n   3. Patients who cannot taper glucocorticoids to ≤5 mg\u002Fday after 6 months of conventional therapy.\n4. SLE disease activity: SLEDAI-2K score ≥ 6.\n5. No occurrence of macrophage activation syndrome within 1 month prior to screening.\n\nMDR-SRNS\n\n1. Age ≥3 years old, male or female.\n2. Diagnosed with SRNS according to the 2021 Kidney Disease: Improving Global Outcomes #KDIGO# Guidelines;\n3. Must meet at least one of the following adequate treatment conditions:\n\n   1. have not achieved a complete response after 12 months of treatment with two standard doses of hormone replacement drugs with different mechanisms of action or relapse of disease activity after remission(at least one of the two drugs is a calcineurin inhibitor such as cyclosporine or tacrolimus, Other replacement drugs include Mycophenolate Mofetil, cyclophosphamide, Taitacept or rituximab).\n   2. if no remission has been achieved after 3 to 6 months of adequate treatment with one calcineurin- inhibitor. The researcher judges that the benefits outweigh the risks and the patient or guardian has fully informed consent, the patient can be considered for inclusion.\n   3. Patients with other diseases, such as systemic lupus erythematosus, requiring long-term systemic treatment with glucocorticoids or immunosuppressants, may be considered for inclusion after the investigator determines that the benefits outweigh the risks, and the patient or guardian has fully informed consent.\n   4. Patients unable to tolerate conventional therapy may be eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant (or guardian if minor) provides fully informed consent.\n4. Renal biopsy was performed and the pathological type was determined to be minimal lesion nephropathy(MCD) or focal segmental glomerulosclerosis (FSGS);\n\nIgA nephropathy\n\n1. Age: ≥ 5 years old,male or female;\n2. IgA nephropathy pathologically confirmed by renal biopsy;\n3. Angiotensin-Converting Enzyme Inhibitors (ACE) or angiotensin receptor blocker (ARB) treated for at least 3 months and meet at least one of the following requirements:\n\n   1. Combination or sequential treatment with steroids and at least one immunosuppressant or biologic for ≥ 3 months; and 24-hour urine protein quantification ≥500mg or UPCR≥0.5mg\u002Fmg;\n   2. \\>50% decline in eGFR within 3 months;\n   3. Patients who are unable to tolerate conventional treatment and for whom the investigator determines the benefits outweigh the risks and who have obtained fully informed consent from the patient or guardian may be considered for inclusion;\n4. Exclude subjects with other secondary causes; exclude patients with uncontrolled blood pressure.\n\nRefractory\u002FRelapsed\u002FProgressive Systemic Sclerosis:\n\n1. Age: ≥ 5 years old, male or female;\n2. Scleroderma fulfilling the 2013 ACR classification criteria\n3. Positive scleroderma-related antibodies.\n4. Modified Rodnan Skin Score (mRSS) ≥ 15 (total score 51).\n5. Must meet at least one of the following adequate treatment conditions:\n\n   1. Treated with glucocorticoids (≥0.5 mg\u002Fkg\u002Fday) plus at least one immunomodulatory agent (including antimalarials, cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, or biologics such as rituximab, belimumab, thalidomide) for more than 3 months without significant improvement.\n   2. Meets criteria for rapidly progressive disease (see Appendix 1) and is unresponsive to standard therapy; participant may be enrolled if the investigator determines that potential benefit outweighs risk and informed consent is obtained.\n   3. Patients unable to tolerate conventional therapy may be eligible if the investigator determines that potential benefit outweighs risk and informed consent is obtained.\n6. Presence of severe pulmonary arterial hypertension (PAH), defined as a mean pulmonary arterial pressure \\>45 mmHg, or other severe involvement of major organs will be exclude.\n\nRefractory\u002FRelapsed ANCA-Associated Vasculitis:\n\n1. Age: ≥ 5 years old, male or female;\n2. Meets the diagnostic criteria for ANCA-associated vasculitis according to the 2007 European Medicines Agency (EMA) algorithm or the 2022 ACR\u002FEULAR classification criteria, including microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA).\n3. Has received glucocorticoids (≥1 mg\u002Fkg\u002Fday) in combination with at least one immunosuppressant or biologic agent (including cyclophosphamide, rituximab, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, belimumab, telitacicept, etc.) for at least 3 months without achieving sustained remission, or has experienced relapse after remission;or meets the criteria for severe vasculitis (Appendix 1), with inadequate response to standard-of-care therapy, and may be considered for enrollment if the investigator determines that the potential benefits outweigh the risks and the patient or legal guardian provides fully informed consent.\n4. Evidence of active vasculitis meeting the following criteria: For participants \\\u003C18 years of age: Pediatric Vasculitis Activity Score (PVAS) ≥10 (total score 63); For participants ≥18 years of age: Birmingham Vasculitis Activity Score (BVAS) ≥10 (total score 63); indicating active vasculitis.\n5. Exclusion Criterion: Presence of alveolar hemorrhage requiring ventilatory support for more than one week.\n\nExclusion Criteria:\n\n1. Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, tocilizumab), or subjects with a history of severe allergic reactions.\n2. Uncontrollable infection, or active infection that requires systemic treatment at screening.\n3. Subjects with grade III or IV heart failure (NYHA classification).\n4. Have a history of congenital heart disease or acute myocardial infarction within 6 months prior to screening; Or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia, etc.); Or combined with moderate to massive pericardial effusion, serious myocarditis, etc; Or patients with unstable vital signs who need hypertensive drugs.\n5. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range; Or hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal reference value range; Or positive for human immunodeficiency virus (HIV) antibodies; Or syphilis test positive; Or cytomegalovirus (CMV) DNA test positive.\n6. History of severe herpes infection prior to screening, such as herpetic encephalitis, ocular herpes, or disseminated herpes; Signs of herpes or varicella-zoster virus infection (especially chickenpox, shingles) within 12 weeks prior to screening.\n7. Patients with active central nervous system disease.\n8. Patients with malignant diseases such as tumors before screening.\n9. Secondary or congenital immunodeficiency.\n10. History of any cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal disease or other major medical condition that would prevent the administration of KN5601-K, except for lupus.\n11. Received solid organ transplantation or hematopoietic stem cell transplantation within 3 months prior to screening; Acute graft-versus host disease (GVHD) of grade 2 or above was present within 2 weeks prior to screening.\n12. Received live vaccine within 4 weeks before screening.\n13. Tested positive in Blood pregnancy test.\n14. Patients who had participated in other clinical trials and received any intervention within 3 months before enrollment.\n15. Any abnormal laboratory test results judged by the investigator to be clinically significant and prevent the subject from participating in the study. Laboratory test values that are out of range and not of clinical significance will not be considered as exclusion criteria.\n16. Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome","ALL","3 Years",{"count":19,"type":20},12,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","Evaluating the efficacy and safety of anti-CD19\u002FBCMA CAR-NK Cells in Paediatric B cell-related autoimmune diseases",[26,27,28],"Paediatric B Cell-related Autoimmune Diseases","Autoimmune Diseases","CAR","RECRUITING","2026-01-31",{"date":32,"type":33},"2026-02-03","ACTUAL",{"date":35,"type":33},"2025-12-03",{"date":37,"type":20},"2029-12-30",{"name":39,"class":40},"The Children's Hospital of Zhejiang University School of Medicine","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":62,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":83},"100301013","phase-1-gpc3-car-t-cells-for-immunotherapy-of-cancer-with-gpc3-expression-100301013","NCT03198546","GPC3-CAR-T Cells for Immunotherapy of Cancer With GPC3 Expression","CAR-T Cell Targeting GPC3 for Immunotherapy of Hepatocellular Carcinoma: Phase I Clinical Trial","Inclusion Criteria:\n\n1. patients with advanced HCC,which express GPC3 protein.\n2. Life expectancy \\>12 weeks\n3. Child-Pugh-Turcotte score \\\u003C7\n4. Adequate heart,lung,liver,kidney function\n5. Available autologous transduced T cells with greater than or equal to 20% expression of GPC3 CAR determined by flow-cytometry and killing of GPC3-positive targets greater than or equal to 20% in cytotoxicity assay\n6. Informed consent explained to, understood by and signed by patient\u002Fguardian. Patient\u002Fguardian given copy of informed consent. -\n\nExclusion Criteria:\n\n1. Had accepted gene therapy before;\n2. Tumor size more than 25cm;\n3. Severe virus infection such as HBV,HCV,HIV,et al\n4. Known HIV positivity\n5. History of liver transplantation\n6. Active infectious disease related to bacteria, virus,fungi,et al\n7. Other severe diseases that the investigators consider not appropriate;\n8. Pregnant or lactating women\n9. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent\u002Fkg\u002Fday)\n10. Other conditions that the investigators consider not appropriate. -","18 Years","75 Years",{"count":52,"type":20},30,[54],"PHASE1","The third\u002Ffourth generation of CAR-T cells that target GPC3 (GPC3-CART cell) and\u002For soluble TGFβ (GPC3\u002FTGFβ-CART )have been constructed and their anti-HCC function has been verified by multiple in vitro and in vivo studies. Clinical studies will be performed to test the anti-cancer function by the GPC3\u002FTGFβ-CAR-T cells in human HCC patients with GPC3 expression. In this phase I study, the safety, tolerance, and preliminary efficacy of the GPC3\u002FTGFβ-CAR-T cell immunotherapy on human will firstly be tested.",[57,58,28,59,60,61],"Hepatocellular Carcinoma","Immunotherapy","GPC3 Gene Inactivation","T Cell","Squamous Cell Lung Cancer",[63,64,65,66,67,68,69,70,71,72,73],"Hepatocellular carcinoma","immunotherapy","CAR-T cell therapy","GPC3 or TGFβ targeting","Phase I clinical study","squamous cell lung cancer","interventional radiology","IL7-CCL19-secreting","SCFV against PD1\u002FCTLA4\u002FTigit","knockdown of PD1\u002FHPK1","DAP10","2024-06-22",{"date":76,"type":33},"2024-06-25",{"date":78,"type":33},"2017-07-01",{"date":80,"type":20},"2036-08-01",{"name":82,"class":40},"Second Affiliated Hospital of Guangzhou Medical University",2,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":94,"briefSummary":96,"conditions":97,"keywords":103,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":83},"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":93,"type":20},40,[95],"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.",[98,99,100,101,102,28],"Lymphoblastic Leukemia","Lymphoblastic Leukemia in Children","Lymphoblastic Leukemia, Acute Adult","B-cell Acute Lymphoblastic Leukemia","Large B-cell Lymphoma",[104,105,106,107],"CAR T-cell therapy","Relapse\u002FRefractory","B-ALL","B-Lineage Lymphoma","2023-03-07",{"date":110,"type":33},"2023-03-09",{"date":112,"type":33},"2022-03-15",{"date":114,"type":20},"2026-12",{"name":116,"class":117},"KK Women's and Children's Hospital","OTHER_GOV",{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":16,"minAge":125,"maxAge":126,"enrollmentInfo":127,"targetDuration":4,"studyType":21,"phases":129,"briefSummary":130,"conditions":131,"keywords":135,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":41},"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":128,"type":20},20,[54],"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).",[132,98,100,99,28,133,134],"Lymphoblastic Leukemia, Acute, Childhood","CAR T-Cell-Related Encephalopathy Syndrome","Refractory Leukemia",[136,65,104],"T-ALL","2021-09-07",{"date":139,"type":33},"2021-09-14",{"date":141,"type":20},"2021-09-08",{"date":143,"type":20},"2026-11-01",{"name":145,"class":40},"National University Hospital, Singapore",{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":16,"minAge":125,"maxAge":154,"enrollmentInfo":155,"targetDuration":4,"studyType":21,"phases":156,"briefSummary":157,"conditions":158,"keywords":159,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":41},"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":93,"type":20},[54],"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).",[132,98,100,99,28,133],[106,65,104],{"date":161,"type":33},"2021-09-09",{"date":163,"type":33},"2021-04-28",{"date":165,"type":20},"2026-08-01",{"name":145,"class":40}]