[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"b-cell-acute-lymphoblastic-leukemia-b-all\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:b-cell-acute-lymphoblastic-leukemia-b-all":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,48,60,87,113,139,163,198,219,247,273,297],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100054149","phase-1-study-of-azd4512-monotherapy-or-in-combination-with-anticancer-agents-in-participants-with-acute-lymphoblastic-leukemia-100054149",false,"NCT07109219","Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Acute Lymphoblastic Leukemia","A Modular Phase I\u002FII, Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy of AZD4512 Monotherapy or in Combination With Anticancer Agent(s) in Participants With Acute Lymphoblastic Leukemia","ALLight","Inclusion Criteria:\n\n* 1\\. Age:\n\n  * 16 years old in Module 1 (US only: ≥18year)\n  * 12 years old in Module 2\n\n    2\\. Diagnosis: Known Diagnosis of CD22-positive B-ALL based on criteria established by WHO (Alaggio et al. 2022).\n* Participants must have relapsed or refractory B-ALL ('relapsed' defined as bone marrow blasts \\> 5% or reappearance of blasts in PB)\n* Module 1 (DE): Ph(-) B-ALL and Ph(+) B-ALL - R\u002FR\n* Backfill of Module 1 and Module 2 (DO): R\u002FR Ph(-) B-ALL\n\n  3\\. Performance status (ECOG ≤ 2; KPS ≥ 50; LPS ≥ 50)\n\n  4\\. Peripheral lymphoblast count \\\u003C 10,000\u002FµL (may receive cytoreduction prior to C1D1 per protocol-specified criteria)\n\n  5\\. At least 2 prior therapies with refractoriness or relapse, or 1 prior therapy with refractoriness or relapse and no standard options available. Participants who have received prior CD22 targeted therapies are eligible.\n* Ph+ B-ALL (Module 1 DE only): intolerant to or have contraindications to TKI therapy or R\u002FR disease despite treatment with at least 2 prior TKIs or at least one 3rd generation TKI\n\n  6\\. Prior DLI \\>4 weeks, prior cell therapy or autoHSCT \\>8 weeks, alloHSCT \\>12 weeks\n\nExclusion Criteria:\n\n1. Burkitt lymphoma and leukemia\n2. Isolated extramedullary disease; Active testicular or CNS (\\> CNS1) involvement\n3. Unresolved non-heme toxicities Grade ≥ 2 (except alopecia, stable Grade ≤ 2 neuropathy, vitiligo, endocrine disorders controlled with therapy)\n4. History of drug-induced non-infectious ILD\u002Fpneumonitis requiring oral or IV steroids or supplemental oxygen or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening\n5. Prior\u002Fconcomitant therapy\n\n   * Cytotoxic treatment within 14 days (except ALL maintenance medications or cytoreduction)\n   * Biologic (immuno-oncology) treatment within 28 days or 5 half-lives (whichever is shorter)\n   * Non-CNS radiation within 2 weeks \\& CNS radiation within 4 weeks\n   * Medications known to prolong QTc and\u002For associated with Torsades de Pointes within 5 half-lives\n   * Strong inhibitors of CYP 3A4 within 14 days or 5 half-lives (whichever is longer)\n   * Investigational agents or study interventions in the last 30 days or 5 half-lives prior to the first dose of AZD4512 whichever is longer. If the investigational product is an agent to treat B-ALL and meets the modality criteria, then a specific washout period must be adhered to instead.","ALL","12 Years",{"count":20,"type":21},83,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The study is intended to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AZD4512 in patients with relapsed\u002Frefractory B-Cell acute lymphoblastic leukemia (r\u002Fr B-ALL).",[28],"B-cell Acute Lymphoblastic Leukemia (B-ALL)",[30,31,32,33,34],"Acute lymphoblastic leukemia (B-ALL)","Dose escalation","Dose optimization","Cluster of differentiation 22 (CD22)","Antibody-drug conjugate (ADC)","RECRUITING","2026-07-10",{"date":38,"type":39},"2026-07-13","ACTUAL",{"date":41,"type":39},"2025-11-12",{"date":43,"type":21},"2028-07-03",{"name":45,"class":46},"AstraZeneca","INDUSTRY",26,{"id":49,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":26,"conditions":52,"keywords":53,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":58,"leadSponsor":59,"locationsCount":47},"100601340",{"count":20,"type":21},[24,25],[28],[30,31,32,33,34],"2026-06-10",{"date":56,"type":39},"2026-06-11",{"date":41,"type":39},{"date":43,"type":21},{"name":45,"class":46},{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":22,"phases":70,"briefSummary":71,"conditions":72,"keywords":73,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},"100526620","phase-1-azd0486-as-monotherapy-in-b-cell-acute-lymphoblastic-leukaemia-100526620","NCT06137118","AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia","A Phase 1\u002F2 Study to Evaluate the Safety and Efficacy of AZD0486 in Adolescent and Adult Participants With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukaemia","SYRUS","Inclusion Criteria:\n\n* Age: 12 years and above (Parts A, B and C).\n* Participants with B-cell Acute Lymphoblastic Leukemia with CD19 expression by local lab with:\n\n  1. Bone marrow infiltration with \\>\u002F= 5% blasts\n  2. Either relapsed or refractory after a minimum of 2 prior therapies or after 1 prior line of therapy if no SOC available option.\n  3. Philadelphia positive participants are allowed in all parts of the study, if intolerant or refractory to TKIs.\n* For participants older than 16 years, Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2. For Participants 16 years or younger, Lansky score more or equal to 50%.\n\nThe above is a summary, other inclusion criteria details may apply.\n\nExclusion Criteria:\n\n* Active CNS involvement by B-ALL, defined by presence of ALL blasts in CSF (CNS2 and CNS3 criteria).\n* Isolated extramedullary disease relapse.\n* Testicular leukemia\n* History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis; or prior Grade 4 neurotoxicity with CAR-T or TCE therapy.\n* History of other malignancy (with certain exceptions).\n* Unresolved AEs \\>\u002F= Grade 2, from prior therapies\n* Prior therapy with TCEs within 4 weeks, CAR T-cell therapy or autologous HSCT within 8 weeks or prior alloSCT within 12 weeks of start of therapy.\n* GVHD requiring immunosuppressive therapy within 3 weeks prior to AZD0486 treatment.\n\nThe above is a summary, other exclusion criteria details may apply.",{"count":69,"type":21},236,[24,25],"This is a Phase 1\u002F2, global multicentre, open-label, single-arm, dose escalation and dose optimisation study of AZD0486 to evaluate the safety, tolerability, and efficacy of AZD0486 monotherapy in participants with R\u002FR B ALL who have received ≥ 2 prior lines of therapies. The study will consist of 3 parts. Part A monotherapy dose escalation. Part B dose optimisation. Part C Dose expansion at the recommended phase 2 dose (RP2D)",[28],[74,75,76,77],"B-cell acute lymphoblastic leukemia","Leukemia","B-lymphocytes","AZD0486","2026-05-25",{"date":80,"type":39},"2026-05-27",{"date":82,"type":39},"2023-12-29",{"date":84,"type":21},"2027-06-29",{"name":45,"class":46},80,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":17,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":4,"studyType":22,"phases":97,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":112},"100608727","early-phase-1-a-clinical-study-evaluating-the-safety-and-efficacy-of-gt801-injection-in-adult-patients-with-relapsedrefractory-cd19-positive-b-cell-hematologic-malignancies-and-autoimmune-hemolytic-anemia-100608727","NCT07205315","A Clinical Study Evaluating the Safety and Efficacy of GT801 Injection in Adult Patients With Relapsed\u002FRefractory CD19-positive B-cell Hematologic Malignancies and Autoimmune Hemolytic Anemia","Inclusion Criteria:\n\n* Aged 18 to 75 years (inclusive), male or female;\n* Participants with refractory or relapsed acute B-cell lymphoblastic leukemia (B-ALL), Chronic Lymphocytic Leukemia (CLL), B-cell Non-Hodgkin's Lymphoma (B-NHL) confirmed by the WHO 2016 Classification, or Autoimmune Hemolytic Anemia (AIHA) diagnosed in accordance with international consensus;\n* Disease progression or recurrence after at least second-line drug treatment;\n* CD19 positivity confirmed by flow cytometry and\u002For histopathology (excluding autoimmune hemolytic anemia);\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1(excluding autoimmune hemolytic anemia);\n* Expected survival period \\> 12 weeks\n* For participants with hematological malignancies, the following requirements must be met:\n\nFor any prior systemic therapy (excluding immune checkpoint inhibitors), an interval of at least 2 weeks or 5 half-lives (whichever is shorter) must have elapsed between the last dose of such therapy and the planned initiation of study treatment.\n\nFor any prior treatment with immune checkpoint inhibitors (e.g., anti-PD-1\u002FPD-L1 monoclonal antibodies such as pembrolizumab, OX40 agonists, 4-1BB agonists, etc.), an interval of at least 3 half-lives or 28 days (whichever is shorter) must have elapsed between the last dose of such treatment and the planned initiation of study treatment.\n\n• For participants with autoimmune hemolytic anemia (AIHA), the following requirements must be met: The total course of glucocorticoid therapy shall be no less than 3 months (except for those who are unable to tolerate due to severe infection, fracture, etc.); Rituximab (100 mg or 375 mg\u002Fm²) shall be administered for at least 4 times, with hemoglobin (HB) remaining below 100 g\u002FL at 12 weeks after the first dose; or rituximab (1000 mg per administration) shall be administered for at least 2 times, with hemoglobin (HB) remaining below 100 g\u002FL at 12 weeks after the first dose; oral administration of any one of the following drugs including mycophenolate mofetil, cyclosporine, azathioprine, cyclophosphamide, etc., shall last for at least 4 months or be discontinued due to intolerance; or intravenous therapy with fludarabine or cyclophosphamide injection shall be administered for at least 2 cycles; or subcutaneous injection of bortezomib shall be administered for at least 4 times.\n\nExclusion Criteria:\n\n* Participants with a history of central nervous system leukemia\u002Flymphoma, or those with central nervous system (CNS) leukemia\u002Flymphoma shown by magnetic resonance imaging (MRI) or PET-CT intracranial imaging during the screening period, or those with detectable malignant cells in cerebrospinal fluid or brain metastases;\n* Subjects with myelofibrosis, myelodysplastic syndromes, aplastic anemia, or other malignant hematological diseases;\n* Subjects with a history of or current comorbidities that cause coagulation disorders and high bleeding risk, such as disseminated intravascular coagulation (DIC), decompensated cirrhosis, esophagogastric varices, etc.;\n* Subjects who experienced severe bleeding (defined as bleeding uncontrollable by medication or local therapy) within 4 weeks prior to screening, or have life-threatening bleeding (associated with thrombocytopenia) currently, or are expected to require emergency treatment within one week after enrollment;\n* Subjects with secondary AIHA induced by drugs or infections;\n* Subjects with hereditary hemolytic diseases or other acquired hemolytic diseases.\n* Participants who undergo hematopoietic stem cell transplantation with therapeutic intent within 12 weeks of planned GT801 infusion;\n* If the participant has a history of hematopoietic stem cell transplantation, the time since the participant received allogeneic hematopoietic stem cell transplantation is ≤ 6 months;\n* Administration of hormonal drugs in any form within 14 days prior to infusion (except for AIHA participants requiring such drugs for hemolysis control and those receiving them for preconditioning).\n* Active hepatitis B and\u002For active hepatitis C (HCV RNA positive); participants who are positive for hepatitis B surface antigen and\u002For core antibody but have HBV-DNA test results within the normal range can be included; participants who are positive for hepatitis C virus (HCV) antibody but with HCV RNA test results within the normal range are eligible for inclusion.\n* Presence of central nervous system diseases or a history thereof, such as epileptic seizures, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar diseases, or any autoimmune diseases involving the central nervous system;\n* Presence of any of the following conditions within 6 months before signing the informed consent form: uncontrolled congestive heart failure (New York Heart Association Class III-IV), angina pectoris, myocardial infarction, cardiomyopathy, stroke (except lacunar infarction), coronary\u002Fperipheral artery bypass surgery, arrhythmias with significant clinical significance (as judged by the investigator) including but not limited to ventricular arrhythmias, significantly prolonged QT interval (recommended QTc ≥ 500ms corrected by Bazett's method, specifically judged by the investigator), poorly controlled hypertension (systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg), poorly controlled diabetes, pulmonary embolism, diffuse pulmonary lesions, pulmonary insufficiency, or medical conditions that the investigator deems unsuitable for the participant to participate in this clinical study;\n* Prior receipt of gene-modified or gene-edited cellular therapy products (except for autologous immune cell therapy products without gene modification or editing, provided that the interval from the last administration to the first dose of GT801 is more than 1 year).\n* A history of autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus) that caused end-organ damage or required systemic immunosuppression\u002Fsystemic disease-modifying agents within the past 2 years.","18 Years","75 Years",{"count":96,"type":21},28,[98],"EARLY_PHASE1","The goal of this clinical study is to evaluate the safety and efficacy of GT801 injection in adult patients with relapsed\u002Frefractory CD19-positive B-cell hematologic malignancies and autoimmune hemolytic anemia. Interim analysis conducted when 2 patients complete primary endpoint measurement.",[28,101,102,103],"Chronic Lymphocytic Leukemia (CLL)","B-cell Non-Hodgkin's Lymphoma (B-NHL)","Autoimmune Hemolytic Anemia (AIHA)","2026-05-22",{"date":80,"type":39},{"date":107,"type":39},"2025-09-26",{"date":109,"type":21},"2028-08-31",{"name":111,"class":46},"Grit Biotechnology",2,{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":17,"minAge":120,"maxAge":121,"enrollmentInfo":122,"targetDuration":4,"studyType":22,"phases":124,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":138},"100476170","phase-1-autologous-hucart19-t-cells-manufactured-using-the-clinimacs-prodigy-platform-for-pediatric-b-all-hucart19-prodigy-100476170","NCT05480449","Autologous HuCART19 T Cells Manufactured Using the CliniMACS Prodigy Platform for Pediatric B-ALL (huCART19 Prodigy)","Phase 1\u002F2b Trial of Autologous Humanized CD19-Directed Chimeric Antigen Receptor T-Cells Manufactured Using the CliniMACS Prodigy Platform for the Treatment of Pediatric B Cell Acute Lymphoblastic Leukemia (B-ALL)","Inclusion Criteria:\n\n1. Signed Informed Informed Consent\n2. Subjects with documented CD19+ ALL or Lly:\n\n   a. Cohort A: Subjects with relapsed or refractory ALL or Lly who have not previously received CAR T-cell Therapy: i. 2nd or greater relapse (marrow or extramedullary) OR ii. Any relapse after allogeneic HSCT and ≥4 months from HSCT at enrollment OR iii. Refractory disease defined as having not achieved an MRD-negative (by multiparameter flow cytometry) or CSF-negative CR after ≥2 chemotherapy regimens\u002Fcycles of frontline therapy, or 1 cycle of reinduction therapy for subjects in first relapse OR iv. Newly diagnosed NCI high-risk B-ALL with induction failure, defined as a M3 bone marrow (≥25%) blasts at the end of induction chemotherapy OR v. First bone marrow relapse of B-ALL at \\\u003C36 months after initial diagnosis OR vi. First or greater CNS relapse of B-ALL vii. Ineligible for allogeneic HSCT because of at least one of the following:\n\n1\\. Comorbid disease 2. Other contraindications to HSCT conditioning regimen 3. Lack of suitable donor 4. Prior HSCT 5. Declines HSCT as the therapeutic option after documented discussion, with expected outcomes, and the role of HSCT with a BMT physician not a part of the study team.\n\nb. Cohort B: Subjects with poor response to prior B cell directed engineered cell therapy, defined as any one of the following: i. Partial response or no response to prior cell therapy ii. CD19+ relapse after prior cell therapy, defined as bone marrow blasts \\> 0.01% by multiparameter flow cytometry or evidence of extramedullary disease iii. Demonstrated early (approximately 6 months from infusion) B cell recovery suggesting loss of engineered cells\n\n3\\. Subjects with prior or current history of CNS3 disease will be eligible if Central Nervous System (CNS) disease is responsive to therapy.\n\n4\\. Documentation of CD19 tumor expression in bone marrow, peripheral blood, cerebrospinal fluid (CSF), or tumor tissue by flow cytometry. If the subject has received CD19-directed therapy, flow cytometry should be obtained after this therapy to demonstrate CD19 expression.\n\n5\\. Age 0-29 years\n\n6\\. Adequate organ function.\n\na. Serum creatinine based on age\u002Fgender b. Adequate liver function: i. ALT within 5x ULN in the absence of ALL infiltration of the liver ii. Bilirubin ≤3x the upper limit of normal iii. ALT and\u002For bilirubin results that exceed this range are acceptable if, in the opinion of the physician-investigator (or as confirmed by liver biopsy), the abnormalities are directly related to ALL infiltration of the liver.\n\nc. Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and \\\u003C Grade 3 hypoxia; DLCO ≥ 40% (corrected for anemia if necessary) if PFTs are clinically appropriate as determined by the investigator.\n\nd. Left Ventricular Shortening Fraction (LVSF) ≥28% or Ejection Fraction (LVEF) ≥45% confirmed by echocardiogram or another scan. In cases where quantitative assessment of LVSF\u002FLVEF is not possible, a statement by the cardiologist that the ECHO shows qualitatively normal ventricular function will suffice.\n\n7\\. Adequate performance status defined as Lanksy or Karnofsky performance score ≥50\n\n8\\. Subjects of reproductive potential must agree to use acceptable birth control methods.\n\nExclusion Criteria:\n\n1. Active hepatitis B or active hepatitis C\n2. HIV infection\n3. Active acute or chronic graft-versus-host disease (GVHD) requiring systemic therapy.\n4. Concurrent use of systemic steroids or immunosuppression at the time of cell infusion or cell collection, or a condition, in the treating physician's opinion, that is likely to require steroid therapy or immunosuppression during collection or after infusion. Steroids for disease treatment at times other than cell collection or at the time of infusion are permitted. Use of physiologic replacement hydrocortisone or inhaled steroids is permitted as well.\n5. CNS disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity.\n6. Subjects who are pregnant or nursing.\n7. Uncontrolled active infection.\n8. History of seizure disorder that requires ongoing anti-epileptic therapy.\n9. If the subject has received previous CAR T cell therapies, history of grade 3 or higher ICANS following administration of a CAR T cell product.","0 Years","29 Years",{"count":123,"type":21},115,[24,25],"This study will determine the safety and efficacy of moving to a second-generation manufacturing process using the CliniMACS Prodigy platform to manufacture huCART19 cells for patients with B cell Acute Lymphoblastic Leukemia (B-ALL).",[127,128],"B Cell Acute Lymphoblastic Leukemia (B-ALL)","B Lineage Lymphoblastic Lymphoma",{"date":130,"type":39},"2026-05-26",{"date":132,"type":39},"2022-09-20",{"date":134,"type":21},"2029-09-20",{"name":136,"class":137},"Stephan Grupp MD PhD","OTHER",1,{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":146,"phases":4,"briefSummary":147,"conditions":148,"keywords":150,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":138},"100596674","car-t-cell-long-term-follow-up-quality-of-life-and-adverse-reactions-100596674","NCT07048535","CAR T-cell Long-Term Follow-Up, Quality of Life and Adverse Reactions","Inclusion Criteria:\n\n* ≤ 26-years old at the time of the first CAR treatment\n* Receipt of a CD19-containing CAR T-cell product (investigational or commercial) for B- ALL\n* Receipt of one unique CAR product (reinfusion of same product allowed)\n* Sustained remission without subsequent therapy post-CAR (exception= post-CAR consolidative HCT)\n* Receipt of only one prior HCT (inclusive of pre- or post-CAR)\n* ≥ 2-years post last CAR T-cell infusion\n\nExclusion Criteria:\n\n* Inability or unwillingness of research participant or legal guardian\u002Frepresentative to give written informed consent",{"count":86,"type":21},"OBSERVATIONAL","To learn more about the long-term health in patients treated for B-Cell Acute Lymphoblastic Leukemia (B-ALL) with Cluster of Differentiation antigen 19 (CD19)\n\n-redirected chimeric antigen receptor (CAR) T-cells.\n\nPrimary Objective:\n\nTo evaluate the feasibility of conducting standardized clinical assessments of pediatric, adolescent and young adult (AYA) B-ALL survivors post CD19-CAR T-cell therapy, treated at multiple institutions, leveraging the St Jude Lifetime Cohort (SJLIFE) clinical and research infrastructure.\n\nExploratory Objectives:\n\n* To describe the prevalence of persistent and new\u002Flate-onset health conditions developing ≥2-years post CD19-CAR T-cell therapy in survivors of pediatric and AYA B-ALL.\n* To characterize neurocognitive and neurologic function in survivors ≥2-years post CD19- CAR T-cell therapy.\n* To characterize immune health in survivors ≥2-years post CD19-CAR T-cell therapy.\n* To characterize functional status in survivors ≥2-years post CD19-CAR T-cell therapy.",[149],"B-Cell Acute Lymphoblastic Leukemia (B-ALL)",[151,152,153],"B-Cell Acute Lymphoblastic Leukemia","B-ALL","Survivorship","2026-04-23",{"date":156,"type":39},"2026-04-29",{"date":158,"type":39},"2025-10-24",{"date":160,"type":21},"2029-07",{"name":162,"class":137},"St. Jude Children's Research Hospital",{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":17,"minAge":171,"maxAge":172,"enrollmentInfo":173,"targetDuration":4,"studyType":146,"phases":4,"briefSummary":175,"conditions":176,"keywords":184,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":112},"100625415","a-multi-site-study-to-evaluate-the-persistence-of-protective-immunity-to-routine-childhood-vaccinations-in-participants-with-b-allly-who-have-received-blinatumomab-100625415","NCT07422337","A Multi-site Study to Evaluate the Persistence of Protective Immunity to Routine Childhood Vaccinations in Participants With B-ALL\u002FLy Who Have Received Blinatumomab","Blinatumomab's Outcome On Serologic Titers and Efficacy of Revaccination","BOOSTER","Inclusion Criteria:\n\n* Diagnosis of B-lineage acute lymphoblastic leukemia\u002Flymphoma\n* ≥1 year old and up to 21 years old at diagnosis\n* Informed consent provided, and if applicable, child assent provided\n* Must have received all vaccinations routinely administered during first year of life\n\nExclusion Criteria:\n\n* Relapsed\u002Frefractory disease at any time\n* Received or will require a bone marrow transplant and\u002For cellular therapy\n* Pregnancy","1 Year","23 Years",{"count":174,"type":21},300,"The goal of this observational study is to establish a clear vaccination protocol for pediatric patients (less than 21 years old) who have received treatment for B-cell Acute Lymphoblastic Leukemia\u002FLymphoma. The main study aims are:\n\n* Evaluate the persistence of protective immunity to routine childhood vaccinations in participants with B-ALL\u002FLy who have received blinatumomab.\n* To determine whether revaccination in participants with non-protective titers leads to restored humoral immunity.\n\nResearchers will compare results from participants who have received immunotherapy to those who have not received immunotherapy to see if immunotherapy versus other chemotherapeutic drugs adversely affect the protective immunity acquired through vaccination.",[177,178,179,180,28,181,182,183],"B-Cell ALL","B-Cell Acute Lymphoblastic Leukaemia","B-Cell Lymphoblastic Leukemia","B-Cell Lymphoblastic Leukemia\u002FLymphoma","B-cell Acute Lymphoblastic Leukemia","B-cell Childhood Acute Lymphoblastic Leukemia","B-cell Leukemia",[185,186,187,188],"vaccines","cancer","blinatumomab","immunotherapy","2026-02-23",{"date":191,"type":39},"2026-02-25",{"date":193,"type":39},"2026-01-13",{"date":195,"type":21},"2029-01",{"name":197,"class":137},"Arkansas Children's Hospital Research Institute",{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":94,"enrollmentInfo":205,"targetDuration":4,"studyType":22,"phases":207,"briefSummary":208,"conditions":209,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":138},"100555644","early-phase-1-jy231-jy231-injection-for-the-treatment-of-b-cell-acute-lymphoblastic-leukemia-b-all-100555644","NCT06514768","JY231 (JY231) Injection for the Treatment of B-cell Acute Lymphoblastic Leukemia (B-ALL)","Early Exploratory Clinical Study on the Safety, Tolerability and Preliminary Efficacy of JY231 Injection in the Treatment of Acute B Lymphoblastic Leukemia","Inclusion Criteria:\n\n1. up to 75 years (Child, Adult) , either sex；\n2. Bone marrow cell morphology examination showed the proportion of primitive and immature lymphocytes in the bone marrow is \\>5%, or the bone marrow MRD analysis comfirmed as B-ALL.\n3. Flow cytometry or histology confirmed positive expression of cluster of differentiation 19 (CD19);\n4. According to the researcher's assessment, the expected survival period is greater than 3 months;\n5. Eastern Cooperative Oncology Group (ECOG) physical condition score ≤ 3;\n6. The patient has good liver, kidney, heart, and lung functions: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal(ULN), which can be relaxed to ≤ 5 × ULN for patients with liver invasion; Total serum bilirubin \\\u003C 34 μ Mol\u002FL; Creatinine clearance rate\\>30 mL\u002Fmin; Cardiac ejection fraction (EF) ≥ 40%, without pericardial effusion and significant arrhythmia; Indoor oxygen saturation (SpO2) ≥ 92%;\n7. Peripheral blood lymphocyte absolute count: absolute lymphocyte count (ALC) ≥ 0.5E9\u002FL, blood platelet (PLT) \\> 30E9\u002FL, Hb \\> 80g\u002FL, with a single venous access and no other contraindications for blood cell separation;\n8. MRI examination showed no active malignant cells in the cerebrospinal fluid, no brain metastases, or no central nervous system leukemia;\n9. Individuals with fertility must agree to the use of efficient contraceptive methods;\n10. The subject or their legal guardian can understand and voluntarily sign a written informed consent form.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women, as well as women with pregnancy plans within six months;\n2. Virological tests of hepatitis B, hepatitis C, AIDS, syphilis and cytomegalovirus were positive;\n3. Having a history of other tumors (excluding skin or cervical carcinoma in situ cured by root therapy and without evidence of disease activity);\n4. Previously received treatment targeting CD19;\n5. Received autologous hematopoietic stem cell transplantation within 6 weeks;\n6. The presence of uncontrollable active bacterial or fungal infections;\n7. Allergies to research related drugs or cellular components;\n8. Active autoimmune diseases exist;\n9. Patients with unstable or active ulcers or gastrointestinal bleeding currently present;\n10. Individuals with mental or psychological disorders who cannot cooperate with treatment and efficacy evaluation;\n11. Received other experimental drug treatments within the past 3 months;\n12. Existence of grade II-IV acute graft versus-host disease (GVHD) or widespread chronic GVHD;\n13. Researchers believe that other reasons are not suitable for clinical trial participants.",{"count":206,"type":21},20,[98],"Early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of B-cell acute lymphoblastic leukemia (B-ALL)",[28],"2025-12-31",{"date":212,"type":39},"2026-01-06",{"date":214,"type":39},"2024-06-20",{"date":216,"type":21},"2026-06-30",{"name":218,"class":137},"920th Hospital of Joint Logistics Support Force of People's Liberation Army of China",{"id":220,"slug":221,"hasResults":11,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":225,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":17,"minAge":171,"maxAge":93,"enrollmentInfo":227,"targetDuration":4,"studyType":22,"phases":229,"briefSummary":231,"conditions":232,"keywords":235,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":246},"100583878","phase-2-newly-diagnosed-low-risk-pediatric-b-cell-all-protocol-100583878","NCT06882057","Newly-diagnosed Low Risk Pediatric B-cell ALL Protocol","Chinese Children's Cancer Group-2025 Protocol for Newly Diagnosed Low Risk Childhood B-cell Acute Lymphoblastic Leukemia","CCCG-LR-B-ALL","Inclusion Criteria:\n\nMust meet all items below:\n\n1. Age older than 1 year and younger than 18 years.\n2. Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.\n3. Diagnosis of B-ALL by immunophenotyping.\n4. Low risk group\n\nExclusion Criteria:\n\nShould be excluded in the presence of any item below:\n\n1. T-ALL\n2. I\u002FHR B-ALL group\n3. sIgM+\n4. Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria.\n5. Philadelphia chromosome positive ALL (Ph-ALL)\n6. ALL evolved from chronic myeloid leukemia (CML).\n7. Down's syndrome, or major congenital or hereditary disease with organ dysfunction\n8. Secondary leukemia\n9. Known underlying congenital immunodeficiency or metabolic disease\n10. Congenital heart disease with cardiac insufficiency.\n11. Glucocorticoid treatment for ≥14 days, or ABL kinase inhibitors for \\> 7 days within one month before enrollment, or any chemotherapy or radiotherapy within 3 months before enrollment (except for emergency radiotherapy to relieve airway compression)",{"count":228,"type":21},3000,[25,230],"PHASE3","CCCG-ALL2025 LR-B-ALL plan is designed based on the CCCG-ALL2020 plan. This is a clinical trial using 14 days of blinatumomab (Blina-14) as early intensification after induction therapy and 2nd Blina-14 in consolidation therapy in all newly diagnosed provisional low-risk (LR) pediatric acute lymphoblastic leukemia (ALL) patients, regardless of measurable residual diseases (MRD) status. We will compare the efficacy of chemotherapy combined with Blina-14, comparing to CAT+ intensification or historical regimens. Patients with early remission in depth will receive chemo-light late intensification and maintenance therapy afterwards. Early complete remission in depth and maintenance reduction will be determined by next-generation sequencing (Ig-NGS MRD).",[233,234,127],"Acute Lymphoblastic Leukemia ALL","Childhood Leukemia, Acute Lymphoblastic",[187,236],"chemo-light","2025-08-23",{"date":239,"type":39},"2025-08-26",{"date":241,"type":39},"2025-03-03",{"date":243,"type":21},"2033-06",{"name":245,"class":137},"Institute of Hematology & Blood Diseases Hospital, China",27,{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":11,"sex":17,"minAge":93,"maxAge":4,"enrollmentInfo":254,"targetDuration":4,"studyType":22,"phases":255,"briefSummary":256,"conditions":257,"keywords":4,"overallStatus":263,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":138},"100601669","phase-1-rn1201injection-for-relapsedrefractory-cd19bcma-hematologic-malignancies-100601669","NCT07113496","RN1201injection for Relapsed\u002FRefractory CD19+\u002FBCMA+ Hematologic Malignancies","An Exploratory Clinical Study on the Safety and Efficacy of Allogeneic CAR-T Cell (RN1201) for Relapsed\u002FRefractory CD19+\u002FBCMA+ Hematologic Malignancies","Inclusion Criteria\n\n1. Voluntary participation with signed informed consent.\n2. Pathologically confirmed CD19-positive and\u002For B-cell maturation antigen (BCMA)-positive hematologic malignancy according to the WHO 2017 classification, including but not limited to multiple myeloma, B-cell acute lymphoblastic leukemia (B-ALL), mature B-cell lymphomas, and plasmablastic lymphoma.\n3. Relapsed\u002Frefractory disease defined as failure to achieve complete remission after standard therapy, or relapse after an initial response during treatment or follow-up.\n4. Measurable disease required:\n\n   1. For B-ALL: persistent minimal residual disease (MRD) positivity despite hematologic remission.\n   2. For lymphoma: at least one measurable lesion ≥1.5 cm in longest diameter per IWG revised criteria.\n   3. For multiple myeloma: positive immunofixation electrophoresis or presence of extramedullary disease.\n5. Age ≥18 years; both sexes eligible.\n6. Expected survival ≥12 weeks.\n7. Adequate organ function (exceptions for disease-related impairment are at the investigator's discretion):\n\n   1. Total bilirubin \\\u003C2× upper limit of normal (ULN); serum creatinine \\\u003CULN; ALT and AST \\\u003C3× ULN.\n   2. Absolute neutrophil count ≥0.5×10⁹\u002FL; platelets ≥20×10⁹\u002FL (no requirement if marrow involvement is documented).\n   3. Eastern Cooperative Oncology Group (ECOG) performance status 0-3.\n   4. Left ventricular ejection fraction (LVEF) ≥50%.\n\nExclusion Criteria\n\n1. Known hypersensitivity, allergy, intolerance, or contraindication to CD19\u002FBCMA-UCAR-T or any study drugs (fludarabine, cyclophosphamide, tocilizumab).\n2. Genetic syndromes: Fanconi, Kostmann, Shwachman, or any documented bone-marrow failure syndrome.\n3. Active or uncontrolled infection requiring IV antibiotics; evidence of severe active infection.\n4. NYHA Class III or IV heart failure (unless clearly secondary to the underlying malignancy).\n5. Central Nervous System (CNS) disorders unrelated to the primary hematologic malignancy.\n6. Prior malignancy except adequately treated carcinoma in situ of skin, cervix, lung, or other non-active tumors.\n7. Significant bleeding diathesis (e.g., gastrointestinal (GI) bleeding, coagulopathy, hypersplenism).\n8. History of significant cardiac disease within the past 3 months that, in the investigator's judgment, renders the patient unable to tolerate study participation..\n9. Pregnancy, lactation, or planned pregnancy within 6 months.\n10. Any condition that, in the investigator's opinion, may increase risk or interfere with study results.",{"count":246,"type":21},[24],"This single-arm, dose-escalation exploratory trial evaluates the safety and efficacy of Allogeneic CAR-T (UCAR-T) cell therapy in patients with relapsed or refractory CD19+\u002FBCMA+ hematologic malignancies, including those with minimal residual disease (MRD). Eligible patients will receive lymphodepletion followed by a single infusion of UCAR-T cells, either post-transplant or without transplantation depending on disease status. The trial assesses overall response and disease control rates, treatment-emergent adverse events, and in vivo behavior of UCAR-T cells.",[258,28,259,260,261,262],"Relapsed or Refractory B-cell Hematologic Malignancies","Multiple Myeloma (MM)","Plasmablastic Lymphoma","Relapsed or Refractory CD19+\u002FBCMA+ Hematologic Malignancies","Mature B-Cell Lymphoma","NOT_YET_RECRUITING","2025-08-08",{"date":266,"type":39},"2025-08-13",{"date":268,"type":21},"2025-08",{"date":270,"type":21},"2027-12",{"name":272,"class":137},"The First Affiliated Hospital with Nanjing Medical University",{"id":274,"slug":275,"hasResults":11,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":279,"eligibilityCriteria":280,"healthyVolunteers":11,"sex":17,"minAge":93,"maxAge":281,"enrollmentInfo":282,"targetDuration":4,"studyType":22,"phases":283,"briefSummary":285,"conditions":286,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":138},"100576440","study-of-nutrition-and-exercise-in-adults-hospitalized-for-treatment-of-acute-lymphoblastic-leukemia-all-100576440","NCT06785324","Study of Nutrition and Exercise in Adults Hospitalized for Treatment of Acute Lymphoblastic Leukemia (ALL)","Nutrition and Exercise to Optimize Muscle and Adiposity in Adults With ALL: NEOMA ALL Trial","NEOMA ALL","Inclusion Criteria:\n\n* New Diagnosis of Philadelphia Chromosome Negative B-ALL\n* Receiving intensive pediatric-inspired induction chemotherapy\n\nExclusion Criteria:\n\n* BMI ≤18.5 kg\u002Fm2 at time of diagnosis\n* Unable to comply with both the recommended diet and exercise regimen as deemed by the research or treatment team\n* Pregnant","50 Years",{"count":206,"type":21},[284],"NA","This clinical trial aims to assess the effect of nutrition and exercise on muscle and adiposity in adults with Philadelphia Chromosome (Ph) Negative B-ALL undergoing inpatient induction therapy.\n\nParticipants will take part in 2 different interventions:\n\n* Nutrition Intervention\n* Physical Exercise Intervention\n\nAll subjects will be provided with a wearable electronic activity monitor (FitBit®) to assist in recording activity levels in minutes of activity.",[287,127,152],"Philadelphia Chromosome Negative","2025-06-18",{"date":290,"type":39},"2025-06-19",{"date":292,"type":39},"2025-05-12",{"date":294,"type":21},"2027-11-06",{"name":296,"class":137},"University of Chicago",{"id":298,"slug":299,"hasResults":11,"nctId":300,"briefTitle":301,"officialTitle":302,"acronym":303,"eligibilityCriteria":304,"healthyVolunteers":11,"sex":17,"minAge":305,"maxAge":93,"enrollmentInfo":306,"targetDuration":4,"studyType":22,"phases":308,"briefSummary":309,"conditions":310,"keywords":311,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":47},"100574819","phase-2-newly-diagnosed-intermediatehigh-risk-pediatric-b-cell-all-protocol-100574819","NCT06764238","Newly-diagnosed Intermediate\u002FHigh Risk Pediatric B-cell ALL Protocol","Chinese Children's Cancer Group-2025 Protocol for Newly Diagnosed for Intermediate\u002FHigh Risk Childhood B-cell ALL","CCCG-I\u002FHR-ALL","Inclusion Criteria:\n\n1. Age older than 1 month to younger than 18 years.\n2. Diagnosis of acute lymphoblastic leukemia by bone marrow morphology.\n3. Diagnosis of B-ALL by immunophenotyping.\n\nExclusion Criteria:\n\n1. Low-risk ALL\n2. sIgM+\n3. Acute leukemias of ambiguous lineage diagnosed according to WHO or EGIL criteria.\n4. ALL evolved from chronic myeloid leukemia (CML).\n5. Down's syndrome, or major congenital or hereditary disease with organ dysfunction\n6. Secondary leukemia\n7. Known underlying congenital immunodeficiency or metabolic disease\n8. Congenital heart disease with cardiac insufficiency.\n9. Treated with glucocorticoids for ≥14 days, or ABL kinase inhibitors for \\> 7 days within one month before enrollment, or any chemotherapy or radiotherapy within 3 months before enrollment (except for emergency radiotherapy to relieve airway compression)","1 Month",{"count":307,"type":21},1800,[25,230],"Building upon the results from the CCCG-ALL-2015, CCCG-ALL-2020 multicenter study cohort, concurrent research findings, and the latest clinical trials, the CCCG-ALL-2025 I\u002FHR-B-ALL is thus developed to further improve the event-free survival (EFS), and overall survival (OS), and quality of life (QoL) of children with intermediate- and high- risk B-cell childhood acute lymphoblastic leukaemia (I\u002FHR-B-ALL), while decreasing adverse reactions and transplantation rates. This trial primarily aims to explore:\n\n1. The efficacy of two randomized Blinatumomab application scheme on I\u002FHR-ALL as determined by MRD negatvitiy rate.\n2. The efficacy of modified mini-hyperCVD + Venetoclax in I\u002FHR-ALL cannot afford blinatumomab, in contrast to historical control as determined by MRD negatvitiy rate.",[233,234,127],[312,313],"blinatimomab","venetoclax","2025-02-04",{"date":316,"type":39},"2025-02-07",{"date":318,"type":39},"2025-01-03",{"date":320,"type":21},"2031-06",{"name":245,"class":137}]