[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"b-cell-all\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:b-cell-all":54},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,38,78],{"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":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":52,"conditions":53,"keywords":62,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"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":49,"type":50},300,"ESTIMATED","OBSERVATIONAL","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.",[54,55,56,57,58,59,60,61],"B-Cell ALL","B-Cell Acute Lymphoblastic Leukaemia","B-Cell Lymphoblastic Leukemia","B-Cell Lymphoblastic Leukemia\u002FLymphoma","B-cell Acute Lymphoblastic Leukemia (B-ALL)","B-cell Acute Lymphoblastic Leukemia","B-cell Childhood Acute Lymphoblastic Leukemia","B-cell Leukemia",[63,64,65,66],"vaccines","cancer","blinatumomab","immunotherapy","RECRUITING","2026-02-23",{"date":30,"type":33},{"date":71,"type":33},"2026-01-13",{"date":73,"type":50},"2029-01",{"name":75,"class":76},"Arkansas Children's Hospital Research Institute","OTHER",2,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":105,"leadSponsor":107,"locationsCount":4},"100575821","phase-2-inaticabtagene-autoleucel-inati-cel-cnct19-treatment-for-newly-diagnosed-b-cell-all-patients-in-cr1-100575821","NCT06777264","Inaticabtagene Autoleucel (Inati-cel; CNCT19) Treatment for Newly Diagnosed B-cell ALL Patients in CR1","Clinical Study on Inaticabtagene Autoleucel (Inati-cel; CNCT19) Injection for Adolescents and Adults With B-Cell Acute Lymphoblastic Leukemia in First Complete Remission (CR1)","JUVENTAS-ALL05","Inclusion Criteria:\n\n1. Age ≥14 years and ≤70 years at screening, with no restrictions on gender.\n2. ECOG performance status of 0 to 1.\n3. Newly diagnosed B-ALL within 12 months and achieving CR1 after standard induction chemotherapy. This includes B-ALL patients with \\\u003C5% bone marrow blasts, no blasts in peripheral blood, and no extramedullary leukemia. Diagnosis and chemotherapy regimen follow the Chinese Guidelines for Diagnosis and Treatment of Adult Acute Lymphoblastic Leukemia (2021 Edition).\n4. At the time of B-ALL diagnosis, leukemia cells in bone marrow or peripheral blood confirmed as CD19-positive via flow cytometry.\n5. Adequate organ function meeting the following criteria:\n\n   1. Aspartate aminotransferase (AST) ≤3× upper limit of normal (ULN).\n   2. Alanine aminotransferase (ALT) ≤3× ULN.\n   3. Total bilirubin ≤2× ULN (for patients with Gilbert's syndrome, total bilirubin ≤3.0× ULN and direct bilirubin ≤1.5× ULN).\n   4. Serum creatinine ≤1.5× ULN, or creatinine clearance ≥60 mL\u002Fmin (calculated using the Cockcroft-Gault formula).\n   5. International Normalized Ratio (INR) ≤1.5× ULN and activated partial thromboplastin time (APTT) ≤1.5× ULN.\n   6. Minimum pulmonary reserve defined as ≤Grade 1 dyspnea and oxygen saturation \\>91% on room air.\n6. No intent or eligibility for hematopoietic stem cell transplantation.\n7. Meets the leukapheresis standards of the study center, with no contraindications for apheresis.\n8. Women of childbearing potential must have a negative blood\u002Furine pregnancy test during the Inati-cel screening period and before preconditioning (results within three days prior to preconditioning). All male and female patients of childbearing potential must agree to use effective contraception throughout the study and for at least two years following study treatment. A female is considered of childbearing potential if biologically capable of having children and engaging in regular sexual activity. Women are considered not of childbearing potential if they meet at least one of the following:\n\n   1. History of hysterectomy, bilateral oophorectomy, or bilateral tubal ligation.\n   2. Medically confirmed ovarian failure.\n   3. Postmenopausal (absence of menstruation for at least 12 consecutive months).\n\nExclusion Criteria:\n\n1. Diagnosis of Burkitt lymphoma\u002Fleukemia, heterozygous or double-hit leukemia, or chronic myeloid leukemia in blast crisis.\n2. Presence of ≥5% blasts in the bone marrow or peripheral blood, or evidence of extramedullary leukemia before screening or preconditioning.\n3. Prior treatment with CAR-T cell therapy or hematopoietic stem cell transplantation (HSCT) before screening or preconditioning.\n4. Genetic syndromes associated with bone marrow failure, including Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or other known bone marrow failure syndromes.\n5. Presence of any of the following conditions:\n\n   1. Positive for HBsAg and\u002For HBeAg.\n   2. Positive for HBe-Ab and\u002For HBc-Ab with HBV-DNA levels above the detectable threshold.\n   3. Positive for HCV-Ab.\n   4. Positive for TP-Ab.\n   5. EBV-DNA or CMV-DNA levels above the detectable threshold.\n   6. Positive for HIV antibodies.\n6. Diagnosis of other malignancies within the past 5 years, unless the tumor was curatively treated, with a follow-up period exceeding 5 years, and a low risk of recurrence as assessed by the investigator.\n7. Presence of any of the following cardiac conditions:\n\n   1. Left ventricular ejection fraction (LVEF) ≤45%.\n   2. Congestive heart failure classified as NYHA class III or IV.\n   3. Severe arrhythmias requiring treatment or clinically significant conduction abnormalities on ECG, including QTc ≥480 ms (QTcB = QT\u002FRR\\^1\u002F2).\n   4. Uncontrolled hypertension (systolic blood pressure ≥150 mmHg and\u002For diastolic blood pressure ≥100 mmHg) or pulmonary hypertension despite standard treatment.\n   5. Unstable angina.\n   6. Myocardial infarction or coronary artery bypass\u002Fstent surgery within the past 6 months.\n   7. Clinically significant valvular disease.\n   8. Other cardiac conditions deemed unsuitable for study enrollment by the investigator.\n8. History of epilepsy, ischemic or hemorrhagic stroke, cerebellar disease, or other active central nervous system disorders.\n9. Clinically significant pleural effusion at the time of screening.\n10. History of deep vein thrombosis or pulmonary embolism within the past 6 months.\n11. Known hypersensitivity to any components of the investigational products used in the trial.\n12. Receipt of live vaccines within 6 weeks prior to screening.\n13. Presence of active infections at the time of screening.\n14. An expected survival of less than 3 months.\n15. Participation in other interventional clinical studies involving investigational drugs:\n\n    1. For investigational drugs not yet approved, the last dose administered less than 3 months before cell infusion.\n    2. For approved drugs, the last dose administered less than 5 half-lives before cell infusion.\n16. Any other conditions deemed unsuitable for study participation by the investigator.","14 Years","70 Years",{"count":89,"type":50},20,"INTERVENTIONAL",[92],"PHASE2","This investigator-initiated, prospective, single-arm, open-label, single-center phase II study aims to evaluate the long-term survival benefit and safety of a commercial CD19 CAR-T product in newly diagnosed Philadelphia chromosome-positive or negative (Ph-positive or Ph-negative) B-cell ALL patients who achieve CR1 after induction chemotherapy. A total of 20 patients will be enrolled in the study. The primary endpoints include disease-free survival (DFS) and overall survival (OS) rates after a median follow-up of 2 years, minimal residual disease (MRD) negativity rate, and the proportion of patients undergoing subsequent hematopoietic stem cell transplantation (HSCT). The frequency and severity of adverse events (AEs) and serious adverse events (SAEs) occurring after infusion will also be recorded.",[95,22],"Acute Lymphoblastic Leukemia",[97,95,98,99],"Chimeric Antigen Receptor T (CAR-T)Cell","B-ALL","Inaticabtagene Autoleucel","NOT_YET_RECRUITING","2025-01-10",{"date":103,"type":33},"2025-01-15",{"date":103,"type":50},{"date":106,"type":50},"2027-01-15",{"name":108,"class":76},"First Affiliated Hospital of Zhejiang University"]