[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"b-all\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:b-all":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,22,0,[8,45,70,83,95,131,153,181,205,231,259,291,325,346,366,387,411,437,457,482,499,522],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100053794","phase-1-anti-crlf2-rtslpr-chimeric-antigen-receptor-t-cells-tslpr-cart-in-participants-with-recurrent-or-refractory-crlf2-rtslpr-overexpressing-b-cell-acute-lymphoblastic-leukemia-b-all-100053794",false,"NCT07572136","Anti-CRLF2-R\u002FTSLPR Chimeric Antigen Receptor T Cells (TSLPR-CART) in Participants With Recurrent or Refractory CRLF2-R\u002FTSLPR-Overexpressing B-Cell Acute Lymphoblastic Leukemia (B-ALL)","Phase I Dose Escalation Study of Anti-CRLF2-R\u002FTSLPR Chimeric Antigen Receptor T Cells (TSLPR-CART) in Participants With Recurrent or Refractory CRLF2-R\u002FTSLPR-Overexpressing B-cell Acute Lymphoblastic Leukemia (B-ALL)","* INCLUSION CRITERIA:\n\n  1. Documentation of pathologic confirmation of a diagnosis of B-Cell acute lymphoblastic leukemia (ALL).\n  2. TSLPR+ expression must be detected on \\>=80% of the malignant cells by NSR device. Note: TSLPR+ expression does not need to be repeated by NSR device if there is a documentation of TSLPR surface expression by flow cytometry from a Clinical Laboratory Improvement Amendments (CLIA) approved laboratory.\n  3. Participants must have a disease that is relapsed or refractory after initial systemic therapy and at least one salvage treatment, and must either be ineligible for, cannot access in a timely manner, or declined alternative curative options (including commercial CAR Tcell constructs\\*, and\u002For have relapsed after allogeneic HSCT).\n\n     \\*Individuals that are CD19 positive will be considered for this study, However, these individuals should be ineligible for, unable to obtain in a timely manner, cannot access, unwilling to undergo, or have failed prior FDA approved CD19 CAR constructs.\n  4. Participants must have measurable or evaluable disease at the screening, defined by any evidence of MRD or positron emission tomography (PET)-avid extramedullary disease\n  5. Age \\>= 18 years\n  6. Clinical performance status: Karnofsky \\>= 50%. Participants who are unable to walk because of paralysis, but who are upright in a wheelchair will be considered ambulatory for the purpose of calculating the performance score.\n  7. Participants must have adequate organ and marrow function as defined below:\n\n     * Leukocytes \\>= 750\u002FmcL\\*\n     * Platelets \\>= 50,000\u002FmcL\\*\n     * Total bilirubin \\\u003C= 2 x upper limit of normal (ULN) (except in the case of participants with documented Gilbert s disease \\> 3 X ULN)\n     * Aspartate Aminotransferase (AST)\u002FAlanine Aminotransferase (ALT) \\\u003C= 5 X institutional ULN\n     * Creatinine \\\u003C 1.5X ULN OR Creatinine clearance \\>= 60 mL\u002Fmin\u002F1.73m\\^2 for participants with creatinine levels above max listed above\n\n       * A participant will not be excluded because of pancytopenia \\>=Grade 3 if it is due to underlying bone marrow involvement by leukemia\n  8. Cardiac function: left ventricular ejection fraction (LVEF) \\>=45% or fractional shortening \\>= 28%, and no clinically significant electrocardiogram (EKG) findings\n  9. Pulmonary Function: Baseline oxygen saturation \\> 92% on room air at rest without oxygen supplementation\n  10. Participants with the following central nervous system (CNS) status are eligible:\n\n      * CNS 1, defined as absence of blasts in CSF on cytospin preparation, regardless of the number of WBCs;\n      * CNS 2, defined as presence of \\\u003C 5\u002FmcL WBCs in CSF and cytospin positive for blasts, or \\> 5\u002FmcL WBCs but negative by Steinherz\u002FBleyer algorithm:\n\n        * CNS 2a: \\\u003C 10\u002FmcL red blood cells (RBCs); \\\u003C 5\u002FmcL WBCs and cytospin positive for blasts;\n        * CNS 2b: \\>=10\u002FmcL RBCs; \\\u003C 5\u002FmcL WBCs and cytospin positive for blasts;\n        * CNS 2c: \\>=10\u002FmcL RBCs; \\>= 5\u002FmcL WBCs and cytospin positive for blasts but negative by Steinherz\u002FBleyer algorithm.\n  11. Contraception:\n\n      * Women of child-bearing potential (WOCBP) must agree to use a highly effective contraception (hormonal, intrauterine device \\[IUD\\], surgical sterilization, abstinence) at the study entry and up to 12 months after the last dose of combined chemotherapy. Note: WOCBP is defined as any individual who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal.\n      * Men able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) at the study entry and for 4 months after the last dose of study drugs. We also will recommend men ask their partners to be on highly effective birth control (hormonal, IUD, surgical sterilization). Men able to father a child must not freeze or donate sperm within the same period.\n  12. Nursing participants must be willing to discontinue nursing from study treatment initiation through 1 month after the last dose of the study drug(s).\n  13. Ability and willingness of participant or Legally Authorized Representative (LAR) to co-enroll on 15-C-0028: Follow-up Evaluation for Gene-Therapy Related Delayed Adverse Events after Participation in Pediatric Oncology Branch Clinical Trials.\n  14. Participant or LAR must understand and sign a written informed consent.\n\n      EXCLUSION CRITERIA:\n\n  \u003C!-- -->\n\n  1. Recurrent or refractory leukemia limited to isolated testicular or isolated CNS disease\n  2. CNS 3 disease including participants with radiologically detected active CNS lymphoma, or participants who have cranial nerve palsy from active CNS leukemia. Note: Chronic complications of prior CNS disease are not exclusionary in the absence of active disease (e.g., blindness from prior ocular CNS disease or persistent cranial nerve palsy)\n  3. Hyperleukocytosis (\\>=50,000 blasts\u002FmcL)\n  4. Positive serum or urine beta-human chorionic gonadotropin (beta-HCG) pregnancy test performed in WOCBP at screening.\n  5. Washout criteria (time prior to apheresis or prior to start of LD if apheresis is not done on this protocol):\n\n     ====\n\n     Therapy: Systemic chemotherapy, antineoplastic investigational agents, or antibody-based therapies, any investigational therapy\n\n     Washout\\*: \\>= 2 weeks\n\n     Exceptions: 6 weeks for clofarabine or nitrosoureas No washout for prior intrathecal chemotherapy, steroid therapy, hydroxyurea (no dose increases within prior 2 weeks) or ALL maintenance type chemotherapy (vincristine, 6- mercaptopurine, oral methotrexate, or a tyrosine kinase for participants with Ph+ or Ph-like ALL) provided there is recovery from any acute toxic effects.\n\n     ====\n\n     Therapy: Radiation therapy\n\n     Washout\\*: \\>= 3 weeks\n\n     Exceptions: No time restriction with radiation therapy if the volume of bone marrow treated is less than 10% and the participant has measurable\u002Fevaluable disease outside the radiation window.\n\n     ====\n\n     Therapy: History of allogeneic HSCT\n\n     Washout\\*: \\>=100 days since HSCT; \\>=30 days since completion of immunosuppression; \\>=6 weeks since donor lymphocyte infusion (DLI)\n\n     ====\n\n     Therapy: History of prior CAR therapy or other adoptive cell therapies\n\n     Washout\\*: \\> 30 days post infusion\n     * Time between prior therapy and apheresis or prior to start of LD if apheresis is not done on this protocol.\n  6. Human immunodeficiency virus (HIV) infection, as measured by seropositivity for HIV antibody.\n  7. Hepatitis B virus (HBV) infection, as measured by positivity for hepatitis B surface antigen (HbsAg).\n  8. Hepatitis C virus (HCV) infection, as measured by seropositivity for hepatitis C.\n  9. Active second malignancy with the exception of in situ carcinoma of the cervix, unless the tumor was treated with curative intent at least two years previously and participant is in remission.\n  10. History of severe, immediate hypersensitivity reactions attributed to compounds of similar chemical or biologic composition to any agents used in study or in the manufacturing of the cells.\n  11. Evidence of active graft-versus- host disease (GVHD).\n  12. Uncontrolled, symptomatic, intercurrent illness or social situations as evaluated by medical history, physical exam, and laboratory evaluations that would limit compliance with study requirements or would pose an unacceptable risk to the participant.","ALL","18 Years","120 Years",{"count":20,"type":21},57,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","Background:\n\nB-cell acute lymphoblastic leukemia (B-ALL) is a type of blood cancer. Some people with B-ALL have a gene mutation that makes the disease hard to treat. The mutation causes cancer cells to make too much of a protein called thymic stromal lymphopoietin receptor (TSLPR). Chimeric antigen receptor (CAR) T cell therapy is a treatment that takes immune cells (T cells) from a person s body and modifies them to attack specific proteins. Researchers want to test whether TSLPR-CART cells can be given safely to adults with forms of B-cell leukemia, and to learn whether the treatment may help fight these cancers.\n\nObjective:\n\nTo test TSLPR-CART in people with B-ALL.\n\nEligibility:\n\nPeople aged 18 years and older with B-ALL that did not respond or returned after treatment. They must have TSLPR on their B-ALL.\n\nDesign:\n\nParticipants will be screened. They will have imaging scans and tests of their heart function. Samples will be taken from their bone marrow. They will have a lumbar puncture: A needle will be inserted into their back to collect a sample of the fluid around the spinal cord.\n\nParticipants will undergo leukapheresis: Blood will be taken from their body through a tube. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different tube. The T cells will be used to create TSLPR-CART.\n\nParticipants will take chemotherapy over 5 days to prepare their body for the therapy; then they will receive the modified cells through a tube inserted into a vein. Staying in the hospital during part of the treatment is expected and participants will be monitored locally to evaluate for side effects. Approximately 1 month after receiving TSLPR-CART, participants will undergo evaluations to see how the TSLPR-CART impacted their leukemia. Participants will have follow-up visits for 2 years after TSLPR-CART either at NIH or at home....",[27,28],"B-All","Acute Lymphoblastic Leukemia",[30,31,28,27],"Adoptive Immunotherapy","CRLF2-R\u002FTSLPR Expressing Tumor","NOT_YET_RECRUITING","2026-07-10",{"date":35,"type":36},"2026-07-13","ACTUAL",{"date":38,"type":21},"2026-07-16",{"date":40,"type":21},"2032-06-30",{"name":42,"class":43},"National Cancer Institute (NCI)","NIH",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100053722","a-multicenter-study-to-evaluate-next-generation-sequencing-ngs-testing-and-monitoring-of-b-cell-recovery-to-guide-management-following-chimeric-antigen-receptor-t-cell-cart-induced-remission-in-children-and-young-adults-with-b-lineage-acute-lymph-100053722","NCT05621291","A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...","A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymphoblastic Leukemia","* INCLUSION CRITERIA:\n* Age \\>=1 year and \\\u003C= 25 years old at the time of CD19 CART infusion\n* Confirmed diagnosis of CD19+ B-ALL with an informative NGS clonality sample\n\n  --Have an informative NGS clonality sample for MRD assessment based on immunoglobulin rearrangement in bone marrow or blood at any time of active disease between diagnosis and CD19 CART infusion and any time prior to the first on-study intervention confirmed by NGS MRD testing.\n* Post-CD19 CART infusion disease status:\n\n  * Are in bone marrow morphologic complete remission and are flow cytometry measurable residual disease (MRD) negative within 42 days post CD19 CART infusion.\n  * Are NGS MRD negative by tracking sample in the bone marrow within 42 days post CD19 CART infusion confirmed by NGS MRD testing.\n* Received first CD19 (4-1BB) CART within 42 days prior to enrollment. Note: Eligible CART including FDA approved Kymriah (tisagenlecleucel) infused on a treatment plan, research study, or other comparable 4-1BB based constructs.\n\nStudy chairs will determine whether other 4-1BB CART are considered comparable.\n\n* All participants must have an allogeneic HCT donor identified for potential HCT. Note: Donor identification and selection will be according to institutional practice.\n* Have B-cell aplasia (BCA) post CD19 CART persisting within 42 days post CD19 CART infusion. Note: BCA persisting is defined as \\\u003C1% B cells lymphocytes or \\\u003C50 B cells\u002Fmicroliter in the peripheral blood\n* Performance of all screening tests prior to day 42 post CD19 CART.\n* The ability of participant or parent\u002Fguardian to understand and the willingness to sign a written consent document or participants unable to consent if they are represented by a Legally Authorized Representative (LAR).\n\nEXCLUSION CRITERIA:\n\n* Prior hematopoietic stem cell transplantation (HCT)\n* Recent history of the extramedullary disease (EMD) that requires ongoing radiographic surveillance (e.g., participants with active EMD at CD19 CART infusion that requires monitoring by imaging without the ability to more precisely assess disease status will be ineligible). A remote history of EMD does not exclude the participant.\n* Active and\u002For residual central nervous system (CNS) disease that requires ongoing therapy or monitoring.\n* Co-morbidities precluding myeloablative HCT. Note: Determination of co-morbidities precluding myeloablative HCT will be made by the treating transplant (HCT) physician and documented in the research record. This does not require that the participant is immediately fully eligible for HCT, only that there are no long-term comorbidities that would preclude a myeloablative approach (e.g., renal failure, severe cardiac failure, long-term oxygen requirement).\n* Uncontrolled, symptomatic, intercurrent illness or social situations that would limit compliance with study requirements. Note: Determination of uncontrolled, symptomatic illness or social situation that would limit compliance with the study requirements will be made by the site-PI and documented in the research record.","1 Year","25 Years",{"count":55,"type":21},60,[57],"NA","Background:\n\nChimeric antigen receptor T-cell (CART) therapy is a form of immunotherapy which can be used to treat people with relapsed B-ALL. For those who achieve remission after CART alone, it may cure up to 50% of people who receive this therapy. However, for people who relapse after CART, it can be hard to achieve remission again. In patients where CART fails, stem cell transplant (HCT) can be used to prevent relapse and achieve cure. But HCT can cause serious side effects. Better testing is needed to distinguish people who can be cured with CART alone from people who may also need to have HCT.\n\nObjective:\n\nTo see if the use of a series of blood and bone marrow tests at regular intervals can help monitor for B-ALL relapse after CART therapy.\n\nEligibility:\n\nPeople aged 1 to 25 years with B-ALL who have had CART therapy within the past 42 days. They must never have had a blood stem cell transplant; they must also have no measurable blood cancer cells.\n\nDesign:\n\nParticipants will visit the clinic every 2 weeks starting 42 days after they receive CART therapy. Each visit will be about the same amount of time as a regular clinic visit. about 8 hours.\n\nParticipants will have blood drawn for testing on each visit.\n\nBone marrow biopsy\u002Faspirate will be done during 4 of the visits at routine timepoints after CART. A needle will be inserted to draw a sample of tissue from inside the bone in the hip.\n\nA small amount of blood and tissue will be tested with ClonoSEQ and to evaluate for normal B-cells side by side with the standard tests.\n\nThe combined testing may help determine whether participants are eligible for HCT and\u002For at risk of relapse after CART.\n\nParticipants will be in the study for 2 years.",[27,28],[27,61,62],"Car-Cure","Result Monitoring","RECRUITING",{"date":35,"type":36},{"date":38,"type":21},{"date":67,"type":21},"2027-12-31",{"name":42,"class":43},8,{"id":71,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":72,"targetDuration":4,"studyType":22,"phases":73,"briefSummary":25,"conditions":74,"keywords":75,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":82,"locationsCount":44},"100636934",{"count":20,"type":21},[24],[27,28],[30,31,28,27],"2026-07-01",{"date":78,"type":36},"2026-07-02",{"date":80,"type":21},"2026-07-07",{"date":40,"type":21},{"name":42,"class":43},{"id":84,"slug":4,"hasResults":11,"nctId":48,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":58,"conditions":89,"keywords":90,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":91,"startDateStruct":92,"completionDateStruct":93,"leadSponsor":94,"locationsCount":69},"100486993","A Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymphoblastic Leu...","A Pilot Trial to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following CAR T-cell Induced Remission in Pediatric Patients With B Lineage Acute Lymphoblastic Leukemia",{"count":55,"type":21},[57],[27,28],[27,61,62],{"date":78,"type":36},{"date":80,"type":21},{"date":67,"type":21},{"name":42,"class":43},{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":4,"studyType":22,"phases":106,"briefSummary":108,"conditions":109,"keywords":119,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":44},"100473255","phase-1-cd19cd22-bicistronic-chimeric-antigen-receptor-car-t-cells-in-children-and-young-adults-with-recurrent-or-refractory-b-cell-malignancies-100473255","NCT05442515","CD19\u002FCD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies","Phase 1\u002F2 Dose Escalation Study of CD19\u002FCD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies","* INCLUSION CRITERIA:\n* Diagnosis\n\n  * Participant must:\n\n    * Have pathology confirmed B cell ALL (not isolated to the testis or CNS), CML with ALL transformation, or high-grade lymphoma (e.g., Burkitt's lymphoma, B-lymphoblastic lymphoma, diffuse large B-cell lymphoma, inclusive of low-grade lymphoma that has transformed to high grade disease); and\n    * Have relapsed or been refractory after at least one standard chemotherapy regimen and at least one salvage treatment. Participants with Philadelphia chromosome + ALL must have failed prior tyrosine kinase inhibitor; and\n    * Be ineligible for allogeneic stem cell transplant (SCT), have refused SCT, or have recurred after SCT; and\n    * Be unable to access (in a timely manner), ineligible for, or have relapsed\u002Ffailed after or not responded to a commercially available CD19 CAR T-cell construct; and\n  * Have evidence of at least minimal residual disease or PET-avid disease (lymphoma) at the time of enrollment.\n* CD22\u002FCD19 expression\n\n  * Cohorts A1b, B1b, C2b\n\n    * CD19 must be detected on \\>15% of the malignant cells by immunohistochemistry or \\> 80% by flow cytometry.\n    * CD22 positivity must be confirmed.\n  * Cohorts D1b, 2 B-ALL\n\n    * CD19 or CD22 positivity must be confirmed\n    * Age \\>= 3 years of age and \\\u003C=39 years of age at time of enrollment.\n    * Clinical Performance status: Participants \\>= 16 years of age: Karnofsky \\>= 50%; Participants \\\u003C 16 years of age: Lansky scale \\>= 50%.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * leukocytes \\>= 750\u002FmcL\\*\n  * platelets \\>= 50,000\u002FmcL\\*\n  * total bilirubin \\\u003C=2 X ULN (except in the case of participants with documented Gilbert's disease \\> 3x ULN)\n  * AST(SGOT)\u002FALT(SGPT) \\\u003C=10 X institutional upper limit of normal\n  * creatinine \\\u003C= the maximum for age listed in the table below OR\n  * measured creatinine clearance \\>=60 mL\u002Fmin\u002F1.73 m\\^2 for participants with creatinine levels above the max listed below per age.\n\n    * Age (Years) \\\u003C= 5 \u002F Maximum Serum Creatinine (mg\u002FdL) \\\u003C= 0.8\n    * Age (Years) 6 to \\\u003C= 10 \u002F Maximum Serum Creatinine (mg\u002FdL) \\\u003C= 1.0\n    * Age (Years) \\>10 \u002F Maximum Serum Creatinine (mg\u002FdL) \\\u003C= 1.2\n\n      * a participant will not be excluded because of pancytopenia \\>= Grade 3 if it is due to underlying bone marrow involvement by leukemia\n* Central nervous system (CNS) Status\n* Participants with leukemia with CNS 1 and 2 disease are eligible in the absence of exclusion criteria\n* Participants of child-bearing or child-fathering potential must be willing to practice effective birth control from the time of enrollment until 12 months following completion of study treatment for women and for 4 months following completion of study treatment for men.\n* Participants who are breastfeeding or plan to breastfeed must agree to discontinue\u002Fpostpone breastfeeding while on study therapy and until 1 month after the administration of CAR.\n* Cardiac function: Left ventricular ejection fraction \\>= 45% or fractional shortening \\>=28%\n* Pulmonary Function\n\n  * Baseline oxygen saturation \\>92% on room air at rest\n* Ability of participant or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.\n* Ability and willingness of participant or Legally Authorized Representative (LAR) to co- enroll on 15-C-0028: Follow-up Evaluation for Gene-Therapy Related Delayed Adverse Events after Participation in Pediatric Oncology Branch Clinical Trials.\n\nEXCLUSION CRITERIA:\n\nParticipants meeting any of the following criteria are not eligible for participation in the study:\n\n* Participants with CNS3 disease, progressing neurologic signs\\* of CNS disease, radiologically detected active CNS lymphoma (\\*resolving manifestation or persistent and\u002For irreversible findings from prior CNS involvement (e.g., blindness) is not exclusionary)\n* Hyperleukocytosis (\\>= 50,000 blasts\u002FmicroL)\n* Positive serum or urine beta-HCG pregnancy test performed at screening.\n* Participants will be excluded based on prior therapy if they fail to meet following washout criteria:\n\n  * Therapy: Systemic Chemotherapy, anti-neoplastic agents, antibody- based therapies\n  * Washout\\*: \\>=2 weeks\n  * Exceptions: 6 weeks for clofarabine or nitrosoureas; No washout for prior intrathecal chemotherapy, steroid therapy, hydroxyurea (no dose increases within prior 2 weeks) or ALL maintenance-type chemotherapy (vincristine, 6-mercaptopurine, oral methotrexate, or a tyrosine kinase inhibitor for participants with Ph+ ALL) provided there is recovery from any acute toxic effects\n  * Therapy: Radiation\n  * Washout\\*: \\>=3 weeks\n  * Exceptions: No time restriction with radiation therapy if the volume of bone marrow treated is less than 10% and the participant has measurable\u002Fevaluable disease outside the radiation window\n  * Therapy: Allogeneic Stem Cell Transplant\n  * Washout\\*: \\>= 100 days since SCT; \\>= 30 days since completion of immunosuppression; \\>= 6 weeks since donor lymphocyte infusion (DLI)\n  * Exceptions: Cannot have evidence of active graft-versus-host disease (GVHD) requiring systemic immunosuppression\n  * Therapy: CAR T-Cell Therapy or other Adoptive Cell Therapy\n  * Washout\\*: \\> 30 days post infusion\n\n    * Washout: Time between therapy and apheresis\n* Positive HIV antibodies consistent with active HIV.\n* Positive hepatitis C antibodies or positive Hepatitis B surface antigen (HbsAG) indicative of current\u002Factive HCV\u002FHBV.\n* Active second malignancy other than in situ carcinoma of the cervix, unless the tumor was treated with curative intent at least two years previously and participant is in remission.\n* History of severe, immediate hypersensitivity reaction attributed to compounds of similar chemical or biologic composition to any agents used in study or in the manufacturing of the cells.\n* Uncontrolled, symptomatic, intercurrent illness or social situations that would limit compliance with study requirements or in the opinion of the PI would pose an unacceptable risk to the participant.","3 Years","39 Years",{"count":105,"type":21},130,[24,107],"PHASE2","Background:\n\nAcute lymphoblastic leukemia (ALL) is the most common cancer in children. About 90% of children and young adults who are treated for ALL can now be cured. But if the disease comes back, the survival rate drops to less than 50%. Better treatments are needed for ALL relapses.\n\nObjective:\n\nTo test chimeric antigen receptor (CAR) therapy. CARs are genetically modified cells created from each patient s own blood cells. his trial will use a new type of CAR T-cell that is targeting both CD19 and CD22 at the same time. CD19 and CD22 are proteins found on the surface of most types of ALL.\n\nEligibility:\n\nPeople aged 3 to 39 with ALL or related B-cell lymphoma that has not been cured by standard therapy.\n\nDesign:\n\nParticipants will be screened. This will include:\n\nPhysical exam\n\nBlood and urine tests\n\nTests of their lung and heart function\n\nImaging scans\n\nBone marrow biopsy. A large needle will be inserted into the body to draw some tissues from the interior of a bone.\n\nLumbar puncture. A needle will be inserted into the lower back to draw fluid from the area around the spinal cord.\n\nParticipants will undergo apheresis. Their blood will circulate through a machine that separates blood into different parts. The portion containing T cells will be collected; the remaining cells and fluids will be returned to the body. The T cells will be changed in a laboratory to make them better at fighting cancer cells.\n\nParticipants will receive chemotherapy starting 4 or 5 days before the CAR treatment.\n\nParticipants will be admitted to the hospital. Their own modified T cells will be returned to their body.\n\nParticipants will visit the clinic 2 times a week for 28 days after treatment. Follow-up will continue for 15 years....",[110,111,112,28,113,27,114,115,116,117,118],"B-NHL","B-Non Hodgkin Lymphoma","Acute Lymphocytic Leukemia","B-precursor ALL","Lymphoma, Non-Hodgkin","Leukemia, Lymphocytic, B Cell","B-Cell Lymphoma","B-Cell Leukemia","Acute Lymphoid Leukemia",[120,121,122,123,30,27,113,28,112,111],"Philadelphia chromosome + ALL","Lymphoma","CD-22 Expressing Tumor","CD-19 expressing tumor","2026-06-30",{"date":76,"type":36},{"date":127,"type":36},"2022-12-28",{"date":129,"type":21},"2029-07-01",{"name":42,"class":43},{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":16,"minAge":102,"maxAge":138,"enrollmentInfo":139,"targetDuration":4,"studyType":22,"phases":141,"briefSummary":142,"conditions":143,"keywords":144,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":44},"100618198","phase-2-cd22-car-t-cells-to-extend-remission-following-commercial-cd19-car-t-cells-in-children-adolescents-and-adults-with-relapsedrefractory-b-cell-acute-lymphoblastic-leukemia-100618198","NCT07328503","CD22 CAR T-cells to Extend Remission Following Commercial CD19 CAR T-cells in Children, Adolescents, and Adults With Relapsed\u002FRefractory B-cell Acute Lymphoblastic Leukemia","A Phase II Study to Examine the Impact of CD22 CAR T-cells to Extend the Duration of Remission Following Commercial CD19 CAR T-cells in Children, Adolescents, and Adults With Relapsed\u002FRefractory B-cell Acute Lymphoblastic Leukemia","* INCLUSION CRITERIA:\n* Participants must have documentation of pathologic confirmation of a diagnosis of relapsed\u002Frefractory B cell acute lymphoblastic leukemia (ALL).\n* History of CD19 and CD22 expression on malignant cells at diagnosis or relapse.\n* Age between \\>= 3 years and \\\u003C= 65 years\n* Participants must have received an FDA-approved CD19 CAR T-cell construct for treatment of B cell ALL within the time period of \\>= 2 months and \\\u003C= 7 months prior to apheresis or lymphodepleting (LD) (if apheresis is not done on this protocol).\n* Must be in an MRD-negative remission as demonstrated by flow cytometry at screening.\n* Must be ineligible for or unwilling to undergo allogeneic stem cell transplant (SCT).\n* Clinical performance status (PS): Karnofsky \\>= 50% (participants \\>= 16 years of age), or Lansky scale \\>= 50% (participants \\\u003C 16 years of age). Participants who are unable to walk because of paralysis, but who are upright in a wheelchair may be considered eligible.\n* Must have no ongoing signs of CRS from prior CAR T cell infusion and\u002For ICANs at screening.\n* Participants must have adequate organ function as defined below:\n\n  * Total bilirubin \\\u003C= 2 x institutional upper limit of normal (ULN)\n  * Aspartate Aminotransferase (AST) \\\u003C= 10 x ULN\n  * Alanine Aminotransferase (ALT) \\\u003C= 10 x ULN\n  * creatinine \\\u003C= the maximum for age listed below OR measured creatinine clearance \\>= 60 mL\u002Fmin\u002F1.73 m\\^2 for participants with\n\ncreatinine levels above the max\n\n* Age: \\\u003C=5, Maximum Serum, Creatinine \\\u003C= .8 mg\u002FdL\n* Age: \\>5 to \\\u003C=10, Maximum Serum, Creatinine \\\u003C= 1.0mg\u002FdL\n* Age: \\>10, Maximum Serum, Creatinine \\\u003C= 1.2mg\u002FdL\n\n  * A participant may have continued to expect CAR T cell-associated cytopenias of any grade.\n  * Cardiac function: left ventricular ejection fraction\\>= 45% or fractional shortening \\>= 28%.\n  * Pulmonary function: baseline oxygen saturation \\>= 92% on room air; participants with respiratory symptoms (e.g., dyspnea, hypoxia \\\u003C92%) must have a diffusing capacity of the lungs for carbon monoxide (DLCO)\u002Fadjusted \\> 45%.\n  * Women of childbearing potential (WOCBP) must agree to use highly effective contraception (hormonal, intrauterine device (IUD), abstinence, surgical sterilization) at the study entry and up to 12 months after the last dose of combined chemotherapy.\n\nNote: WOCBP is defined as any individual who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal.\n\nMen able to father a child must agree to use an effective method of contraception (barrier, surgical sterilization, abstinence) at the study entry and up to 7 months after the last dose of study drugs. We also will recommend men ask their partners to be on highly effective birth control (hormonal, IUD, surgical sterilization). Individuals able to father a child must not freeze or donate sperm within the same period.\n\n* Nursing participants must be willing to discontinue nursing from study treatment initiation through 6 months after the last dose of the study drug(s).\n* Participants must be enrolled on protocol 15-C-0028, Follow-Up Evaluation for Gene- Therapy Related Delayed Adverse Events after Participation in Pediatric Oncology Branch Clinical Trials.\n* Ability of participant or \u002FLegally Authorized Representative (LAR) to understand and be willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\n* Any central nervous system (CNS) involvement or signs of non-CNS extramedullary disease.\n* Any active graft versus host disease (GVHD) in participants who are post-HSCT.\n* Participants with disease recurrence requiring therapy post CD19 CAR. Note: Maintenance therapy post CD19 CAR (e.g., vincristine or tyrosine kinase inhibitor) for remission maintenance is allowed and will require a 1-week washout prior to apheresis or LD (if apheresis is not done on this protocol).\n* Any investigational agent within 1 week before apheresis or LD (if apheresis is not done on this protocol).\n* Pregnancy confirmed with beta-human chorionic gonadotropin (beta-HCG) serum or urine test performed at screening.\n* Human immunodeficiency virus (HIV) infection, as measured by seropositivity for (HIV) antibody.\n* Hepatitis B virus (HBV) infection, as measured by positivity for hepatitis B surface antigen (HBsAg).\n* Hepatitis C virus (HCV) infection, as measured by seropositivity for hepatitis C.\n* History of severe, immediate hypersensitivity reaction attributed to compounds of similar chemical or biological composition to any agent used in the study or in the manufacturing of cells.\n* Uncontrolled, symptomatic intercurrent illness evaluated by medical history, physical exam, and\u002For laboratory testing, or social situation that would limit compliance with study requirements or would pose an unacceptable risk to the participant.","65 Years",{"count":140,"type":21},20,[107],"Background:\n\nAcute lymphoblastic leukemia (ALL) is a type of blood cancer. Chimeric antigen receptor (CAR) therapy involves taking immune cells (T cells) from a person and modifying them to better target cancer cells. CAR T-cell therapy that targets a marker called CD19 has been show to can cure ALL in many children and adults. But in about 50% of patients, the ALL comes back within a year. Researchers want to find out if a second treatment with CAR T-cell therapy that targets a different marker, CD22, can keep the cancer away longer.\n\nObjective:\n\nTo see if CD22 CAR T-cell therapy can keep ALL away longer.\n\nEligibility:\n\nPeople aged 3 to 65 years who have no signs of cancer after CD19 CAR T-cell treatment for ALL.\n\nDesign:\n\nParticipants will be screened. They will have imaging scans and tests of their heart function. A sample of tissue (biopsy) will be collected from their bone marrow. They will have a fluid sample collected from the area around their spinal cord.\n\nParticipants will undergo collection of their white blood cells (T cells) during a procedure called leukapheresis. Blood will be taken from their body through a vein. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different vein. The cells will be altered in a lab to create CD22 CAR T-cell therapy.\n\nParticipants will take drugs over 4 consecutive days to prepare their body for the CAR T-cell therapy; then they will receive their modified T cells through a tube inserted into a vein. Some people may need to stay in the hospital during treatment.\n\nParticipants will have follow-up visits for 2 years.",[28,27],[27,28,122,123,30],"2026-06-18",{"date":147,"type":36},"2026-06-22",{"date":149,"type":36},"2026-06-16",{"date":151,"type":21},"2031-01-31",{"name":42,"class":43},{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":160,"enrollmentInfo":161,"targetDuration":4,"studyType":163,"phases":4,"briefSummary":164,"conditions":165,"keywords":169,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":172,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":180},"100560616","prospective-evaluation-of-delayed-effects-of-pediatric-car-t-cell-therapy-100560616","NCT06579469","Prospective Evaluation Of Delayed Effects Of Pediatric Car T Cell Therapy","Prospective Evaluation Of Delayed Effects Of Pediatric Car T Cell Therapy (PROSPER)","Inclusion Criteria:\n\n* Participants must have received an initial systemically-administered CAR T cell infusion within the last 1-3 months (+\u002F- 14 days).\n\n  * Initial infusion is defined as the first administration of a CAR T cell product the participant has not previously received OR receipt of a CAR T cell product previously received after an interval allogeneic HSCT.\n* Age ≤ 30 years at CAR T cell infusion.\n\nExclusion Criteria:\n\n* Active malignancy other than the disease under study.\n* Planned consolidative HSCT within 3 months post CAR T cell infusion.\n* Received or planned additional disease directed therapy post CAR T cell infusion.\n* Inability or unwillingness of research participant or legal guardian\u002Frepresentative to give written informed consent.","30 Years",{"count":162,"type":21},100,"OBSERVATIONAL","This study is being done to learn more about the short-term and long-term side effects of CAR-T cell therapy. Specifically, researchers want to know how often patients get infections, have delays in recovering blood cell counts and\u002For have damage to the nervous system.",[166,167,168],"B-ALL","Hematologic Malignancy","Solid Tumor",[170,171],"CAR T cell infusion","Late Effects",{"date":145,"type":36},{"date":174,"type":36},"2026-01-20",{"date":176,"type":21},"2029-03",{"name":178,"class":179},"St. Jude Children's Research Hospital","OTHER",6,{"id":182,"slug":183,"hasResults":11,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":188,"enrollmentInfo":189,"targetDuration":4,"studyType":22,"phases":191,"briefSummary":192,"conditions":193,"keywords":196,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":44},"100617071","phase-1-a-study-of-inotuzumab-and-blinatumomab-in-people-with-b-cell-acute-lymphoblastic-leukemia-100617071","NCT07313852","A Study of Inotuzumab and Blinatumomab in People With B-cell Acute Lymphoblastic Leukemia","A Phase 1\u002F2 Study of Concurrent Inotuzumab and Subcutaneous Blinatumomab in Adult Patients With B-cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* Age ≥ 18 years of age.\n* Newly diagnosed CD19+ and CD22+ B-ALL with the following characteristics\n\n  * Patients ≥55 years old, OR\n  * Patients 18-54 years old who decline or are deemed unfit for conventional chemotherapy with at least one of the following criteria:\n* ECOG performance status of 2 or more\n* Severe cardiac comorbidity (including congestive heart failure requiring treatment)\n* Known pulmonary comorbidity (including DLCO ≤65% or FEV1 ≤65%)\n* Renal comorbidity (including creatinine clearance 30-45 mL\u002Fmin)\n* Relapsed or refractory CD19+ and CD22+ B-ALL\n* Patients with extramedullary disease will be allowed as long as they have detectable disease by flow cytometry in the bone marrow\n* Peripheral absolute lymphoblast count of ≤ 10,000\u002Fml after pre-phase (not required for enrollment but required to proceed with first dose of inotuzumab).\n* Philadelphia chromosome negative by FISH\u002Fkaryotype for t(19;22) or RT PCR for bcr-abl transcript.\n* CD19 and CD22 expression will be confirmed by enrolling institutions prior to study registration by flow cytometry and\u002For IHC.\n* Creatinine clearance ≥30 mL\u002Fmin\n* Total bilirubin ≤ 1.5 x upper limit of normal, AST and ALT ≤3.0x upper limit of normal (ULN)\n* QTcF ≤ 480\n* Ejection fraction ≥ 50%\n\nExclusion Criteria:\n\n* Patients with Burkitt's lymphoma, T-ALL, CML in lymphoid blast crisis and mixed phenotype acute leukemia (MPAL).\n* Patients with newly diagnosed B-ALL who received prior treatments, with the exception of corticosteroid, hydroxyurea, or one dose of vincristine, are ineligible.\n* Patients with Ph+ B-ALL by FISH or RT PCR.\n* ECOG performance status \\>3.\n* Left ventricular ejection fraction (LVEF) \\\u003C50%.\n* History of sinusoidal obstruction syndrome (SOS), also known as veno-occlusive disease (VOD).\n* Prior treatment with inotuzumab\n* History of liver cirrhosis\n* Ongoing need for systemic T-cell suppressive therapy (e.g. corticosteroids, tacrolimus, cyclosporine, etc.) Patients need to be off calcineurin inhibitors for at least 4 weeks in order to be eligible for enrollment.\n* Active Grade 2-4 acute graft versus host disease (GVHD), graded with the modified Glucksberg criteria and\u002For GVHD requiring systemic steroids in excess of physiologic replacement\n* Moderate or severe chronic GVHD graded with the NIH 2014 criteria\n* Pregnant or lactating women. Women and men of childbearing age should use effective contraception while on this study and continue for the following time periods: female patients of reproductive potential should use effective contraception during treatment and for 8 months after last treatment dose. Males with female partners of reproductive potential should use effective contraception during treatment and for 5 months after the last dose.\n* Patients with HIV or active hepatitis B or hepatitis C infection are ineligible. Patients with a prior history of hepatitis B or hepatitis C who have negative HBV\u002FHCV PCR respectively at the time of screening are eligible\n* Patients with concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation or hormonal therapy, with the exception of squamous and basal cell carcinoma of the skin, in situ cervical cancer, adequately treated stage I\u002FII cancer from which the patient is current in complete remission, or any other cancer from which the patient has been disease free for five years\n* Patients with history or presence of clinically significant neurological disorders such as epilepsy, generalized seizure disorder, or severe brain injuries.\n* Any other issue which, in the opinion of the treating physician, would make the patient ineligible for the study.","55 Years",{"count":190,"type":21},26,[24,107],"The purpose of this study is to find out whether combining inotuzumab and blinatumomab is a safe and effective treatment for participants with newly diagnosed B-cell acute lymphoblastic leukemia (B-ALL).",[194,195,166],"B-cell Acute Lymphoblastic Leukemia","B-Cell Acute Lymphoblastic Leukemia, Adult",[194,195,166,197],"Memorial Sloan Kettering Cancer Center","2026-06-15",{"date":149,"type":36},{"date":201,"type":21},"2026-06",{"date":203,"type":21},"2029-01",{"name":197,"class":179},{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":211,"enrollmentInfo":212,"targetDuration":4,"studyType":22,"phases":214,"briefSummary":215,"conditions":216,"keywords":220,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":230},"100386972","phase-1-cd123-directed-t-cell-therapy-for-acute-myelogenous-leukemia-catchaml-100386972","NCT04318678","CD123-Directed T-Cell Therapy for Acute Myelogenous Leukemia (CATCHAML)","Inclusion Criteria for Procurement and T-cell Production:\n\n* Age ≤21 years old\n* Relapsed\u002Frefractory CD123+ disease defined as follows:\n\nAML\u002FMDS\n\n* Relapsed disease: Patients developing recurrent disease after a first complete remission (CR)\n* Refractory disease: Patients not achieving a CR after 2 cycles of induction chemotherapy\n\nB-cell ALL\n\n* Relapsed disease that is CD123 positive and CD19 negative\u002Fdim or patients otherwise ineligible for CD19 directed therapies including\n\n  * Patients in 2nd or greater relapse\n  * Patients with relapse after allogeneic HSCT\n* Refractory disease that is CD123 positive and CD19 negative\u002Fdim or patients otherwise ineligible for CD19 directed therapies\n\nT-cell All • Relapsed refractory disease that is CD123 positive\n\nBPDCN\n\n• Relapsed\u002Frefractory disease that has failed front-line therapy\n\n* Estimated life expectancy of \\>12 weeks\n* Karnofsky or Lansky (age-dependent) performance score ≥50\n* Patients with a history of prior allogeneic HCT must be clinically recovered from prior HCT therapy, have no evidence of active GVHD and have not received a donor lymphocyte infusion (DLI) within the 28 days prior to apheresis\n* Patient must have an identified, suitable HCT donor\n* For females of child-bearing age:\n* Not lactating with intent to breastfeed\n* Not pregnant with negative serum pregnancy test within 7 days prior to enrollment\n* Meets eligibility criteria to undergo autologous apheresis, or have previously undergone autologous apheresis\n\nExclusion Criteria:\n\n* Known primary immunodeficiency\n* History of HIV infection\n* Severe intercurrent uncontrolled bacterial, viral or fungal infection (e.g. active hepatitis B or C infection or adenovirus infection)\n* History of hypersensitivity reactions to murine protein-containing products\n* Patients with acute promyelocytic leukemia (APL, t (15;17))\n* Known contraindication to the protocol defined lymphodepleting chemotherapy regimen of fludarabine\u002Fcyclophosphamide.\n\nInclusion Criteria for Treatment:\n\n* Age≤21 years old\n* Detectable disease that is CD123+ (at least MRD+ disease)\n* Estimated life expectancy of \\>8 weeks\n* Karnofsky or Lansky (age-dependent) performance score≥50\n* Patients with a history of prior allogeneic HCT must be clinically recovered from prior HCT therapy, have no evidence of active GVHD and have not received a donor lymphocyte infusion (DLI) within the 28 days prior to planned infusion\n* Patient must have an identified, suitable HCT donor\n* Adequate cardiac function defined as left ventricular ejection fraction \\>40%, OR shortening fraction ≥25%\n* EKG without evidence of clinically significant arrhythmia\n* Adequate renal function defined as creatinine clearance or radioisotope GFR ≥50 ml\u002Fmin\u002F1.73m2 (GFR ≥40 ml\u002Fmin\u002F1.73m2 if \\\u003C 2 years of age)\n* Adequate pulmonary function defined as forced vital capacity (FVC)≥50% of predicted value; or pulse oximetry≥92% on room air if patient is unable to perform pulmonary function testing\n* Total Bilirubin≤3 times the upper limit of normal for age, except in subjects with Gilbert's syndrome\n* Alanine aminotransferase (ALT) OR aspartate aminotransferase (AST) ≤5 times the upper limit of normal for age\n* Has recovered from all NCI CTAE grade III-IV, non-hematologic acute toxicities from prior therapy\n* For females of child-bearing age\n\n  * Not lactating with intent to breastfeed\n  * Not pregnant with negative serum pregnancy test within 7 days prior to enrollment\n* If sexually active, agreement to use birth control until 3 months after T- cell infusion. Male partners should use a condom.\n* Available autologous transduced T-cell product that has met GMP release criteria\n\nExclusion Criteria:\n\n* Known primary immunodeficiency\n* History of HIV infection\n* Severe intercurrent uncontrolled bacterial, viral or fungal infection\n* History of hypersensitivity reactions to murine protein-containing products\n* History of severe hypersensitivity reactions to cornstarch or hydroxyethyl starch.\n* Receiving systemic steroids therapy exceeding the equivalent of 0.5 mg\u002Fkg\u002Fday of methylprednisolone, in the 7 days prior to CD123-CAR T- cell infusion\n* Receiving systemic therapy in the 14 days prior to CD123-CAR T-cell infusion, which will interfere with the activity of the CD123-CAR T cells in vivo (in the opinion of the study PI(s))\n* Receiving rituximab therapy in the 30 days prior to CD123-CAR T cell infusion. (This exclusion criterion is intended to prevent premature exposure of CD123-CAR T cells to rituximab, which would activate the safety switch and promote CAR T-cell apoptosis).\n* Receiving intrathecal chemotherapy in the 7 days prior to CD123-CAR T cell infusion.\n* Known contraindication to the protocol defined lymphodepleting chemotherapy regimen of fludarabine\u002Fcyclophosphamide.\n* Active CNS disease","21 Years",{"count":213,"type":21},108,[24],"The CD123-CAR T-cell therapy is a new treatment that is being investigated for treatment of AML\u002Fmyelodysplastic syndrome (MDS), T- or B- acute lymphoblastic leukemia (ALL) or blastic plasmacytoid dendritic cell neoplasia (BPDCN). The purpose of this study is to find the maximum (highest) dose of CD123-CAR T cells that is safe to give to these patients. This would include studying the side effects of the chemotherapy, as well as the CD123-CAR T-cell product on the recipient's body, disease and overall survival.\n\nPrimary Objective:\n\n* To determine the safety of one intravenous infusion of escalating doses of autologous, CD123-CAR T cells in patients (≤21 years) with recurrent\u002Frefractory CD123+ disease (AML\u002FMDS, B-ALL, T-ALL or BPDCN) after lymphodepleting chemotherapy.\n* To determine the safety of an intravenous infusion of escalating doses of donor derived, CD123-CAR T cells in patients (≤21 years) with recurrent\u002Frefractory CD123+ disease (AML\u002FMDS, B-ALL, T-ALL, BPDCN or MPAL) after lymphodepleting chemotherapy.\n\nSecondary Objectives\n\n\\- To evaluate the antileukemia activity of CD123-CAR T cells.\n\nExploratory Objectives\n\n* To assess the immunophenotype, clonal structure and endogenous repertoire of CD123-CAR T cells and unmodified T cells\n* To characterize the cytokine profile in the peripheral blood and CSF after treatment with CD123-CAR T cells\n* To characterize tumor cells post CD123-CAR T-cell therapy\n* To compare in vivo properties of donor-derived versus autologous CD123- CAR T cells",[217,166,218,219],"AML\u002FMDS","T-ALL","BPDCN",[221],"CD123+","2026-05-18",{"date":224,"type":36},"2026-05-19",{"date":226,"type":36},"2020-07-29",{"date":228,"type":21},"2030-07-29",{"name":178,"class":179},2,{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":16,"minAge":238,"maxAge":4,"enrollmentInfo":239,"targetDuration":4,"studyType":22,"phases":241,"briefSummary":242,"conditions":243,"keywords":245,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":230},"100635751","phase-1-a-safety-and-efficacy-study-of-cd-19-t-hank-in-patients-with-b-cell-acute-lymphoblastic-leukemia-100635751","NCT07556757","A Safety and Efficacy Study of CD-19 t-haNK in Patients With B-cell Acute Lymphoblastic Leukemia","A Phase 1 Open-label Study of CD19 t-hANK as a Single Agent in Participants With Selected CD19+ Relapsed B-cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n1. Age ≥ 12 years old.\n2. Able to understand and provide a signed informed consent that fulfills the relevant Human Research Ethics Committee (HREC) or Independent Ethics Committee (IEC) guidelines.\n3. Histologically or flow cytometry documented pre B-ALL.\n4. Relapsed after achieving a 2nd complete remission (CR) or failed one cycle of re-induction therapy or with MRD positivity after ≥ 2 cycles of induction.\n5. Must be willing to undergo a lumbar puncture (LP) for CSF analysis and administration of IT chemotherapy.\n6. Performance status: Lansky score \\>60%, for participant ≥12 to \\\u003C16 years. Eastern Cooperative Oncology Group (ECOG) score of ≤ 1 for participants ≥ 16 years.\n7. Expected survival \\> 16 weeks.\n8. Stated willingness to comply with study procedures.\n9. Able to attend required study visits and return for adequate follow-up, as required by this protocol.\n10. Agreement to practice effective contraception for female participants of childbearing potential and nonsterile males. Female participants of childbearing potential must agree to use effective contraception while on study and for at least 30 days after the last dose of study drug. Nonsterile male participants must agree to use a condom while on study and for up to 5 months after the last dose of study drug. Effective contraception includes orals, injectables, surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm), and implants such as intrauterine devices (IUDs).\n\nAll inclusion criteria must be answered \"yes\" for a participant to participate in the trial.\n\nExclusion Criteria:\n\n1. Participants with T-cell leukaemia and Burkitt's M3 leukaemia.\n2. Known hypersensitivity or allergy to any component of the study medication(s), including sulfa-containing (eg, dimethyl sulfoxide, DMSO).\n3. Inadequate organ function, evidenced by the following laboratory results:\n\n   1. Serum creatinine ≥ 2 mg\u002FdL\n   2. Aspartate aminotransferase (AST) \u002F Alanine aminotransferase (ALT) ≥ 5 upper limit of normal (ULN)\n   3. Total bilirubin ≥ 2 mg\u002FdL\n4. Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drug used in this study or that would put the participant at high risk for treatment related complications.\n5. History of significant autoimmune disease OR active, uncontrolled autoimmune phenomenon: such as systemic lupus erythematous, Wegner's glomerulonephritis, autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura requiring steroid therapy defined as \\> 20 mg of prednisone or equivalent daily.\n6. History of allogeneic hematopoietic stem-cell transplantation (HSCT) requiring ongoing systemic graft versus host disease (GvHD) therapy.\n7. History of receiving allograft organ transplant requiring immunosuppression.\n8. Participants post solid organ transplant who develop high grade lymphomas or leukaemias.\n9. Nonmalignant CNS disease (eg, stroke, epilepsy, vasculitis, or neurodegenerative disease).\n10. History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).\n11. Uncontrolled hypertension (systolic \\> 160 mm Hg and\u002For diastolic \\> 110 mm Hg) or clinically significant (ie, active) cardiovascular disease, cerebrovascular accident\u002Fstroke, or myocardial infarction within 6 months prior to first study medication; unstable angina; congestive heart failure of New York Heart Association Class 2 or higher; or serious cardiac arrhythmia requiring medication.\n12. Current chronic daily treatment (continuous for \\> 3 months) with systemic corticosteroids defined as \\> 20 mg of prednisone or equivalent daily, excluding inhaled steroids. Short-term steroid use to prevent IV contrast allergic reaction or anaphylaxis in participants who have known contrast allergies is allowed.\n13. Currently taking any medication(s) (herbal or prescribed) known to have an adverse drug reaction with any of the study medications.\n14. History of human immunodeficiency virus (HIV) with current CD4+ T-cell count \\\u003C 350 cells\u002FμL and a detectable HIV viral load.\n15. Known carriers of hepatitis B virus (HBV) infection that is currently hepatitis B surface antigen (HBsAg) positive.\n16. Concurrent active malignancy other than basal or squamous cell carcinomas of the skin.\n17. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.\n18. Women who are pregnant or breastfeeding.\n\nAll exclusion criteria must be answered \"no\" for a participant to participate in the trial.","12 Years",{"count":240,"type":21},10,[24],"This is a phase 1, open-label study to evaluate the safety and efficacy of CD19 t-haNK in patients with B-cell acute lymphoblastic leukemia. Up to 10 patients will receive at least 1 dose of study drug.",[166,244],"Leukemia",[246,247,248],"B-Cell","Acute","Lymphoblastic","2026-04-22",{"date":251,"type":36},"2026-04-29",{"date":253,"type":36},"2025-04-11",{"date":255,"type":21},"2028-12",{"name":257,"class":258},"ImmunityBio, Inc.","INDUSTRY",{"id":260,"slug":261,"hasResults":11,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":11,"sex":16,"minAge":102,"maxAge":266,"enrollmentInfo":267,"targetDuration":4,"studyType":22,"phases":269,"briefSummary":271,"conditions":272,"keywords":276,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":44},"100626873","phase-3-cd19-car-t-vs-dli-for-post-hsct-mrd-in-ph--all-a-rct-100626873","NCT07441291","CD19 CAR-T vs DLI for Post-HSCT MRD in Ph- ALL: A RCT","CD19 Chimeric Antigen Receptor T-Cell Therapy Versus Donor Lymphocyte Infusion for Minimal Residual Disease in Patients With Ph-Negative Acute B-Lymphoblastic Leukemia After Hematopoietic Stem Cell Transplantation: A Prospective, Open-Label, Randomized Controlled Trial","Inclusion Criteria:\n\n* age 3-\\\u003C80 years\n* ECOG performance status 0-2\n* post-HSCT MRD positivity (≥0.1% CD19+ abnormal B cells by flow cytometry)\n* no hematological\u002Fextramedullary relapse\n* adequate organ function\n* negative pregnancy test (for fertile females)\n\nExclusion Criteria:\n\n* active infections\n* uncontrolled graft-versus-host disease (GVHD)\n* history of central nervous system disorders\n* autoimmune diseases\n* other active malignancies","79 Years",{"count":268,"type":21},70,[270],"PHASE3","This prospective, open-label randomized controlled trial compares CD19 CAR-T therapy with chemotherapy plus donor lymphocyte infusion (DLI) in 70 patients with Ph-negative B-cell acute lymphoblastic leukemia (B-ALL) who exhibited minimal residual disease (MRD) positivity (≥0.1% CD19+ abnormal B cells) after allogeneic hematopoietic stem cell transplantation (HSCT).\n\nPatients (aged 3-\\\u003C80 years, ECOG 0-2, no relapse, adequate organ function) were randomized to receive either autologous CD19 CAR-T cells following lymphodepletion or conventional chemotherapy with DLI.\n\nThe primary endpoint is the MRD negativity rate at 3 months. Secondary endpoints include 1-year MRD positivity, relapse rate, overall survival, disease-free survival, GVHD incidence, GVHD-free relapse-free survival, and duration of severe hematological toxicity.\n\nThe study includes a 1-year follow-up and permits crossover to the alternative treatment for patients with persistent MRD (≥0.1%) at 3 months in the absence of relapse.",[273,274,275],"B ALL","Allogenetic Hematopoietic Stem Cell Transplantation","MRD-positive",[277,278,279,280,281],"CD19 CAR-T","Donor Lymphocyte Infusion (DLI)","Ph-negative B-ALL","Minimal Residual Disease (MRD)","Hematopoietic Stem Cell Transplantation (HSCT)","2026-02-24",{"date":284,"type":36},"2026-02-27",{"date":286,"type":36},"2025-11-30",{"date":288,"type":21},"2028-12-30",{"name":290,"class":179},"Peking University People's Hospital",{"id":292,"slug":293,"hasResults":11,"nctId":294,"briefTitle":295,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":22,"phases":299,"briefSummary":301,"conditions":302,"keywords":312,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":316,"lastUpdatePostDateStruct":317,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":324},"100401858","early-phase-1-iomab-act-a-pilot-study-of-131-i-apamistamab-followed-by-cd19-targeted-car-t-cell-therapy-for-patients-with-relapsed-or-refractory-b-cell-acute-lymphoblastic-leukemia-or-diffuse-large-b-cell-lymphoma-100401858","NCT04512716","Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma","Patients with B-ALL or DLBCL (or subtypes thereof) who have relapsed or refractory disease will be eligible. Refractory disease is defined by failure to achieve at least a partial response or disease progression within 6 months of the last therapy. Patients who initially respond but subsequently demonstrate disease progression are considered to have relapsed disease\n\nParticipant Inclusion Criteria:\n\n\\- To be eligible for leukapheresis, patients must have a CD19+ B-cell malignancy with relapsed or refractory disease, defined below. To be eligible for 131-I apamistamab conditioning and treatment with 19-28z CAR T-cells, patients must additionally have detectable evidence of residual malignancy at the time of assessment prior to CAR T-cell infusion (as defined below), regardless of therapy administered following leukapheresis.\n\na. Patients with diffuse large B-cell lymphoma (de novo or DLBCL transformed from an indolent lymphoma (follicular lymphoma, chronic lymphocytic leukemia \\[Richter syndrome\\]) or high-grade B-cell lymphoma (HGBL): (\"DLBCL patients\") i. Defined as relapsed or refractory DLBCL or high-grade B-cell lymphoma (HGBL) following 2 or more prior chemoimmunotherapy regimens (with at least one course including an anthracycline and CD20-directed therapy) following diagnosis of de novo DLBCL\u002FHGBL or DLBCL arising from indolent lymphoma, and requiring further treatment. Exception: patients with Richter syndrome (DLBCL arising from CLL\u002Fsmall lymphocytic lymphoma) are eligible following 1 or more prior chemoimmunotherapy regimens (with at least one course including an anthracycline and CD20-directed therapy) and do not require a second course of chemoimmunotherapy to be eligible.\n\nii. Patients must have at least one FDG-avid (PET-avid) measurable lesion iii. Biopsy confirmation of relapsed of refractory DLBCL is required iv. For patients who have received treatment for confirmed relapsed or refractory disease otherwise meeting criteria a.i.-a.iii. as above, within 6 weeks of study enrollment, active disease does not need to be re-confirmed or present immediately prior to Screening A for the patient to be eligible for leukapheresis. However, detectable evidence of residual malignancy must be present at Screening B in order for the patient to be eligible for 131-I apamistamab and CAR T-cell therapy.\n\nb. Patients with B-cell acute lymphoblastic leukemia or B lymphoblastic lymphoma (ALL) or chronic myeloid leukemia (CML) in lymphoid blast crisis: (\"B-ALL patients\") i. Patients with Philadelphia chromosome-negative B-cell ALL must have been refractory to at least 1 line of multi-agent chemotherapy or relapsed following at least 1 prior multiagent systemic chemotherapy regimen that included induction and consolidation therapy ii. Patients with Philadelphia chromosome-positive ALL or CML in lymphoid blast crisis must have exhibited persistent disease following therapy with a second- or third-generation tyrosine kinase inhibitor iii. Patients must have ≥5% bone marrow involvement and\u002For at least one FDG-avid (PET-avid) measurable extramedullary lesion iv. For patients who have received treatment for confirmed relapsed or refractory disease otherwise meeting criteria b.i.-b.iii. as above, within 6 weeks of study enrollment, active disease does not need to be re-confirmed or present immediately prior to Screening A for the patient to be eligible for leukapheresis. However, detectable evidence of residual malignancy must be present at Screening B in order for the patient to be eligible for 131-I apamistamab and CAR T-cell therapy.\n\n* While prior CD19-targeted therapies, including CAR T-cell therapy, do not exclude participation, CD19 expression by immunohistochemical staining or flow cytometry must be confirmed prior to enrollment.\n* Age ≥ 18 years of age\n* Creatinine clearance ≥50 mL\u002Fmin as calculated by the Cockroft-Gault formula\n* Direct bilirubin ≤2.0 mg\u002FdL, AST and ALT ≤3.0x upper limit of normal (ULN), unless liver dysfunction is thought to be related to underlying malignancy\n* Adequate pulmonary function as assessed by ≥92% oxygen saturation on room air by pulse oximetry.\n* Adequate bone marrow function meeting the following criteria as defined below, without requiring blood product or granulocyte-colony stimulating factor support in the past 7 days, unless cytopenias are attributed to underlying malignancy in the opinion of the investigator:\n\n  1. Absolute neutrophil count ≥0.5k\u002FµL,\n  2. Platelets ≥30k\u002FµL,\n  3. Hemoglobin ≥7g\u002FdL.\n* ECOG performance status 0-2.\n\nParticipant Exclusion Criteria:\n\n* ECOG performance status ≥3.\n* Pregnant or lactating patients. Patients of childbearing age should use effective contraception while on this study and continue for 1 year after all treatment is finished.\n* Impaired cardiac function (LVEF \\\u003C40%) as assessed by echocardiogram or MUGA scan during screening\n* Patients with active graft versus host disease following allogeneic hematopoietic cell transplantation requiring systemic T-cell suppressive therapy are ineligible\n* Patients with active autoimmune disease requiring systemic T-cell suppressive therapy are ineligible\n* Patients with following cardiac conditions will be excluded:\n\n  1. New York Heart Association (NYHA) stage III or IV congestive heart failure\n  2. Myocardial infarction ≤6 months prior to enrollment\n  3. Any history of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration\n  4. Any history of severe non-ischemic cardiomyopathy with LVEF ≤20%\n* Have current or prior positive test results for human immunodeficiency virus (HIV) or hepatitis B (HBV) or C (HCV), with the following exceptions:\n\n  1. Subjects who have positive HBV test results due to having been previously vaccinated against hepatitis B, as evidenced by negative hepatitis B surface antigen (HBsAg), negative anti- hepatitis B core protein (HBc) and positive antibody to the HBsAg (anti-HBs) are not excluded.\n  2. Subjects who have antibodies to HCV or who have hepatitis B core antibody, with undetectable viremia by PCR, and with adequate organ function as defined in the protocol, are not excluded.\n* Patients with uncontrolled systemic fungal, bacterial, viral or other infection are ineligible.\n* Patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation or hormonal therapy, with the exception of squamous and basal cell carcinoma of skin.\n* Patients with history or presence of clinically significant neurological disorders such as epilepsy, generalized seizure disorder, severe brain injuries are ineligible.\n* Any other issue which, in the opinion of the treating physician, would make the patient ineligible for the study.\n* Patients with circulating human anti-mouse antibodies to BC8 noted on initial screening (see Appendix III)\n\nSubject Inclusion Criteria for 131-I Apamistamab Infusion Patients should meet performance status and organ function parameters as specified, without known development of an exclusion criterion, prior to proceeding to 131-I apamistamab infusion. See Section 9.2 re: screening for treatment.",{"count":298,"type":21},12,[300],"EARLY_PHASE1","This is a pilot study; patients will receive 131-I apamistamab prior to CAR T-cell infusion in order to determine the maximum tolerated dose of 131-I apamistamab is exceeded at 75 mCi, and if so, to assess the safety of a step-down dose of 50 mCi.",[166,303,273,304,305,306,307,308,309,310,311],"DLBCL","Dlbcl-Ci","DLBCL Unclassifiable","DLBCL, Nos Genetic Subtypes","DLBCL Activated B-Cell Type","DLBCL Germinal Center B-Cell Type","Diffuse Large B-cell Lymphoma","HGBL","HGBL, Nos",[313,314,315,197],"CD19+ B-cell malignancy","131-I apamistamab","B-cell malignancy","2026-02-13",{"date":318,"type":36},"2026-02-17",{"date":320,"type":36},"2021-02-02",{"date":322,"type":21},"2027-01",{"name":197,"class":179},7,{"id":326,"slug":327,"hasResults":11,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":4,"eligibilityCriteria":331,"healthyVolunteers":11,"sex":16,"minAge":102,"maxAge":53,"enrollmentInfo":332,"targetDuration":4,"studyType":22,"phases":334,"briefSummary":335,"conditions":336,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":44},"100611732","phase-2-assessment-of-senlb19-car-t-cells-in-relapsedrefractory-cd19-b-all-100611732","NCT07244406","Assessment of Senl_B19 CAR-T Cells in Relapsed\u002FRefractory CD19+ B-ALL","A Phase II, Open-Label, Multicenter Clinical Study to Evaluate the Efficacy and Safety of Senl_B19 Autologous Anti-CD19 CAR-T Cells in Subjects With Relapsed or Refractory CD19-Positive B-Cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* 1.Sign the informed consent and be willing and able to comply with the visit, treatment regimen, laboratory examination and other requirements of the study as stipulated in the trial flow chart; 2.Male or female subjects. Age between 3 and 25 years (inclusive) at the time of ICF signing； 3.Confirmed diagnosis of relapsed\u002Frefractory B-ALL at ICF signing; 4.\\>5% blasts on screening bone marrow biopsy\u002Faspirate; 5.CD19+ malignant cells by flow cytometry (bone marrow or peripheral blood) at screening; 6.Patients with Ph+ ALL are eligible if they meet the relapsed\u002Frefractory criteria and have either: failed ≥2 TKI regimens (unless they have a T315I mutation), demonstrated TKI intolerance, or have a contraindication to TKIs; 7.Estimated survival time\\>3 months.\n\nExclusion Criteria:\n\n* 1.Relapse of isolated extramedullary disease; 2.Burkitt lymphoma\u002Fleukemia； 3.Active acute or moderate-to-severe chronic GVHD within 4 weeks prior to ICF signing. Or, any systemic GVHD treatment within 4 weeks prior to infusion; 4.No uncontrolled active infection at the time of ICF signing or apheresis.; 5.Prior receipt of any CAR-T therapy or other cellular\u002Fgene therapy before screening; 6.Received investigational drugs or systemic anti-tumor therapy within 4 weeks or 5 half-lives (whichever longer) prior to apheresis; 7.Active interstitial lung disease\u002Fpneumonitis at the time of ICF signing; 8.Subjects whom the Investigator considers unable to comply with the study protocol or who are otherwise not an appropriate candidate for the study for any reason;",{"count":333,"type":21},59,[107],"To evaluate the efficacy and safety of S1904 in patients with relapsed or refractory CD19+B-ALL.",[166],"2025-11-17",{"date":339,"type":36},"2025-11-24",{"date":341,"type":36},"2025-01-10",{"date":343,"type":21},"2028-12-31",{"name":345,"class":258},"Hebei Senlang Biotechnology Inc., Ltd.",{"id":347,"slug":348,"hasResults":11,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":4,"eligibilityCriteria":352,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":353,"enrollmentInfo":354,"targetDuration":4,"studyType":22,"phases":356,"briefSummary":357,"conditions":358,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":359,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":44},"100611909","phase-1-ksv01-injection-as-the-therapy-for-relapsedrefractory-b-cell-acute-lymphoblastic-leukemia-100611909","NCT07246707","KSV01 Injection as the Therapy for Relapsed\u002FRefractory B-Cell Acute Lymphoblastic Leukemia","A Phase I Clinical Study on the Safety, Tolerability, and Efficacy of KSV01 Injection in Patients With Relapsed\u002FRefractory B-Cell Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n1. Voluntary participation and provision of written informed consent by the patient or their legally authorized representative.\n2. Aged 18 to 80 years (inclusive), any gender.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.\n4. Life expectancy \\> 3 months.\n5. Diagnosis of B-cell Acute Lymphoblastic Leukemia (B-ALL) according to the 2016 WHO classification, with relapsed\u002Frefractory disease defined by meeting at least one of the following criteria:\n\n   * Relapse within 12 months of achieving first remission with standard therapy.\n   * Primary refractory disease: failure to achieve Complete Remission (CR) after two or more cycles of standard chemotherapy.\n   * Relapsed disease after two or more instances of CR.\n   * Relapsed or refractory disease following autologous or allogeneic Hematopoietic Stem Cell Transplantation (HSCT).\n6. Documented CD19-positive leukemia cells in bone marrow or peripheral blood within 1 month prior to screening.\n7. Morphological disease in the bone marrow (blasts ≥5%).\n8. For patients with Philadelphia chromosome-positive ALL (Ph+ ALL): must be refractory or intolerant to at least two Tyrosine Kinase Inhibitors (TKIs), including at least one second-generation TKI. Patients with a T315I mutation are exempt from prior TKI salvage therapy.\n9. Absolute Lymphocyte Count (ALC) ≥ 100\u002FμL.\n10. Adequate organ function as defined by:\n\n    1. Hepatic: Alanine aminotransferase (ALT) ≤ 3 × Upper Limit of Normal (ULN); Aspartate aminotransferase (AST) ≤ 3 × ULN; Total bilirubin ≤ 2 × ULN (or ≤ 3 × ULN with a diagnosis of Gilbert's syndrome, with direct bilirubin ≤ 1.5 × ULN).\n    2. Renal: Creatinine clearance (calculated by Cockcroft-Gault formula) ≥ 60 mL\u002Fmin.\n    3. Pulmonary: Oxygen saturation (SaO2) ≥ 92% on room air, and no active pulmonary infection.\n    4. Cardiac: Left Ventricular Ejection Fraction (LVEF) ≥ 40% by echocardiography; absence of significant pericardial effusion; no clinically significant electrocardiogram (ECG) abnormalities.\n11. For women of childbearing potential: negative urine or serum pregnancy test at screening, and agreement to use effective contraception for at least 1 year post-infusion. Male subjects with partners of childbearing potential must agree to use effective barrier contraception for at least 1 year post-infusion.\n12. For subjects with prior blinatumomab (CD3-CD19 bispecific T-cell engager) therapy: CD19 tumor expression on blasts (from bone marrow or peripheral blood) must be documented after the most recent cycle of blinatumomab. If CD19 expression is quantified, the percentage of CD19-positive blasts must be ≥90%.\n\nExclusion Criteria:\n\n1. Diagnosis of Burkitt's leukemia\u002Flymphoma according to WHO 2016, or chronic myeloid leukemia in accelerated or blast phase.\n2. History of another primary malignancy that has not been in continuous remission for at least 2 years. Exceptions to the 2-year limit include: non-melanoma skin cancer, curatively treated Stage I solid tumor with low risk of recurrence, cured carcinoma in situ of the cervix (biopsy-confirmed) or squamous intraepithelial lesion on Pap smear, and cured localized prostate cancer.\n3. Uncontrolled active infection within 4 weeks prior to enrollment.\n4. Active hepatitis B or hepatitis C virus infection.\n5. HIV infection.\n6. Positive for Treponema pallidum(syphilis).\n7. Severe active autoimmune disease or immunodeficiency, with the exception of well-controlled Type I diabetes and thyroid disorders.\n8. History of severe allergy or hypersensitivity to macromolecular biological agents (e.g., antibodies, cytokines).\n9. Participation in another interventional clinical trial within 4 weeks prior to enrollment.\n10. History of clinically significant central nervous system (CNS) disorders, including but not limited to epilepsy, paresis, aphasia, stroke, severe head injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome.\n11. Central Nervous System (CNS) involvement:\n\n    * Presence of CNS 3 disease, defined as detectable blasts in the cerebrospinal fluid (CSF) with ≥5 WBCs\u002Fmm³, with or without neurological symptoms.\n    * Presence of CNS 2 disease, defined as detectable blasts in the CSF with \\\u003C5 WBCs\u002Fmm³ AND the presence of neurological symptoms.\n\n    Note: Subjects with CNS 1 status (no detectable leukemic blasts in CSF) and subjects with CNS 2 status without significant clinical neurological abnormalities are eligible.\n    * History or presence of any CNS disorder, such as seizure disorder, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, any autoimmune disorder involving the CNS, posterior reversible encephalopathy syndrome, or cerebral edema.\n12. History of concomitant genetic syndromes associated with bone marrow failure, such as Fanconi anemia, Kostmann syndrome (severe congenital neutropenia), Shwachman-Diamond syndrome.\n13. History of any of the following cardiovascular conditions within the past 6 months: New York Heart Association (NYHA) Class III or IV heart failure, cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease.\n14. Active psychiatric illness.\n15. History of drug abuse\u002Faddiction.\n16. Use of the following medications or therapies:\n\n    1. Salvage systemic therapy (including chemotherapy, TKIs for Ph+ ALL, and blinatumomab) within 1 week or 5 half-lives (whichever is shorter) prior to study drug infusion.\n\n       Note:\n\n       TKIs and hydroxyurea must be discontinued at least 72 hours prior to study drug infusion.\\* 6-mercaptopurine, 6-thioguanine, methotrexate (standard dose), cytarabine (standard dose), vincristine, and asparaginase must be discontinued at least 1 week prior.\\* Intrathecal chemotherapy for CNS prophylaxis must be discontinued at least 1 week prior.\\* PEG-asparaginase must be discontinued at least 4 weeks prior.\\*\n    2. Prior anti-CD19 therapy other than blinatumomab.\n    3. History of Grade 4 neurological toxicity (per CTCAE v5.0) or Grade 4 CRS (per Lee 2014 criteria) during prior blinatumomab treatment.\n    4. Prior treatment with alemtuzumab within 6 months, or with clofarabine or cladribine within 3 months prior to study drug infusion.\n    5. Systemic treatment for Graft-versus-Host Disease (e.g., calcineurin inhibitors, methotrexate, mycophenolate mofetil, sirolimus, thalidomide) or immunosuppressive antibody therapy (e.g., anti-CD20, anti-TNF, anti-IL-6, or anti-IL-6R antibodies) within 4 weeks prior to enrollment.\n    6. Any prior systemic therapy with inhibitory\u002Fstimulatory immune checkpoint molecules (e.g., ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists). A washout period of at least 3 half-lives from the last dose is required before enrollment.\n    7. Radiotherapy: Non-CNS directed radiotherapy within 2 weeks or CNS-directed radiotherapy within 8 weeks prior to study drug infusion.\n    8. Corticosteroids: Therapeutic doses of corticosteroids (defined as prednisone equivalent \\>20 mg\u002Fday) within 72 hours prior to study drug infusion. Physiologic replacement doses, and topical or inhaled steroids are permitted.\n    9. Prior gene therapy.\n    10. Prior adoptive cell therapy.\n17. Acute Graft-versus-Host Disease (GVHD) of Grade II to IV per Glucksberg criteria, or overall grade B-D per the IBMTR Severity Index; OR acute or chronic GVHD requiring systemic therapy within 4 weeks prior to enrollment.\n18. Administration of a live vaccine within 4 weeks prior to enrollment.\n19. Pregnancy or lactation.\n20. Any condition that, in the investigator's judgment, may compromise the subject's ability to complete all required study visits and procedures (including follow-up), or comply with the study requirements.","80 Years",{"count":355,"type":21},30,[24],"This is a single center, single arm, open-label, dose escalation, phase 1 study to evaluate the safety, tolerability and preliminary efficacy of KSV01 injection for patients with relapsed\u002Frefractory B-Cell acute lymphoblastic leukemia (r\u002Fr B-ALL).",[166],{"date":339,"type":36},{"date":361,"type":21},"2025-11",{"date":363,"type":21},"2028-06",{"name":365,"class":179},"Zhejiang University",{"id":367,"slug":368,"hasResults":11,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":4,"eligibilityCriteria":372,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":373,"enrollmentInfo":374,"targetDuration":4,"studyType":22,"phases":375,"briefSummary":376,"conditions":377,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":44},"100569105","jy231jy231-injection-for-the-treatment-of-relapsed-or-refractory-b-cell-lymphoma-leukemia-100569105","NCT06689917","JY231(JY231) Injection for the Treatment of Relapsed or Refractory B Cell Lymphoma\u002F Leukemia","An Early Exploratory Clinical Study of the Safety, Tolerability and Preliminary Efficacy of JY231 Injection in the Treatment of Relapsed or Refractory B-cell Lymphoma\u002FLeukaemia","Inclusion Criteria:\n\n1. Subject voluntarily sign informed consent and are willing and able to comply with all trial requirements;\n2. Age is 18-75 years old and gender is not limited;\n3. Malignancy cells in bone marrow or peripheral blood are Cluster of Differentiation 19 - positive(CD19+) detected by flow cytometric analysis;\n4. Meet the clinical criteria for relapsed or refractory B-cell lymphoma, including: indolent lymphoma (iNHL), such as follicular lymphoma (FL) and marginal zone lymphoma (MZL); aggressive B-cell lymphoma, like diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed follicular lymphoma (TFL), and T-rich lymphocyte-bearing large B-cell lymphoma (TCRBCL), or have a diagnosis of acute B-lymphocytic leukemia (B-ALL) and meet one of the following conditions:\n\n   * Refractory B-ALL: those who did not achieve complete remission after 2 courses of standard induction regimen chemotherapy, or those who did not achieve complete remission after first-line or multi-line salvage chemotherapy;\n   * Relapsed B-ALL: relapse within 12 months after first remission, or relapse after first-line \u002F multi-line salvage chemotherapy;\n   * Relapse after autologous or allogeneic hematopoietic stem cell transplantation; In addition, patients with Philadelphia chromosome positive (Ph +) should be relapsed after at least two tyrosine kinase inhibitors (TKI) treatment, or they could not tolerate TKI therapy, or have a t315i mutation, resistant to TKI drugs.\n5. Morphological examination of bone marrow cells showed the proportion of primitive and naive lymphocytes was\\> 5%;\n6. No Hematopoietic Stem Cell Transplantation(HSCT) within 6 months before enrollment;\n7. At least one measurable lesion was imaging for relapsed or refractory B cell lymphoma, long diameter of\\> 15mm, or extranodal lesion of\\> 10mm, along with a positive Positron Emission Tomography - Computed Tomography(PET-CT) examination.\n8. More than 12 weeks of expected survival period\n9. Baseline Eastern Cooperative Oncology Group(ECOG) score was 0-1;\n10. Adequate organ function (criteria regarding liver and kidney function can be moderately relaxed):\n\n    * Glutamic aminotransferase (ALT) ≤3 times upper limit of normal (ULN);\n    * Grass aminotransferase (AST) ≤3 times ULN;\n    * Total bilirubin ≤1.5 times ULN;\n    * Serum creatinine ≤ 1.5 times ULN, or creatinine clearance ≥ 60 mL\u002Fmin;\n    * Indoor oxygen saturation ≥ 92%;\n    * Left ventricular ejection fraction (LVEF)≥55%, echocardiography confirmed no pericardial effusion and no clinically significant ECG findings;\n    * There is no clinically significant pleural effusion;\n11. Adequate bone marrow reserve without transfusion, defined as:\n\n    * Absolute neutrophil count (ANC)\\>1.000 \u002F mm3;\n    * Absolute lymphocyte count (ALC)≥ 300 \u002F mm3;\n    * Platelet≥50.000\u002Fmm3;\n    * Hemoglobin\\>8.0 g\u002Fdl;\n12. Subjects using the following drugs need to meet the following conditions:\n\n    * Steroids: The therapeutic dose of steroids must be stopped 72 hours before JY231 infusion. However, physiological alternative doses of steroids are allowed;\n    * Immunosuppression: Any immunosuppressive drug must be stopped at ≥4 weeks prior to enrollment;\n    * Antiproliferative therapy other than lymphodepletion chemotherapy within two weeks of infusion;\n    * Cluster of Differentiation 20(CD20) antibody-related therapy must be stopped within 4 weeks before infusion or 5 half-lives after the CD20 antibody;\n    * CNS disease prophylaxis must be stopped 1 week before JY231 infusion (e. g. intrathecal methotrexate).\n13. Reproductive men, sexual partners ensure effective contraception; fertile women, adopted effective contraception and agreed to use contraception throughout the study period.\n\nExclusion Criteria:\n\n1. Subjects with active cerebrospinal fluid malignant cells or brain metastases, or subjects with active central nervous system (CNS) lymphoma, or CNS leukaemia;\n2. Subjects with a history of active CNS disease, such as seizures, cerebrovascular ischemia \u002F hemorrhage, dementia, cerebellar disease, or any autoimmune disease associated with CNS involvement;\n3. Subjects who have received other study drugs within 30 days before screening, or are still in the washout period;\n4. Patients who have previously received any anti-CD19 \u002F anti-Cluster of Differentiation 3(CD3) therapy or any other anti-CD19 therapy (except for those with normal T cell numbers and function and with CD19-positive tumors);\n5. Patients who have been previously treated with any gene therapy product, including Chimeric Antigen Receptor T(CAR-T) therapy (except patients who do not have CAR-T cells in vivo and have normal T cell number and function and are with CD19 positive tumors);\n6. Subjects with radiation therapy within 2 weeks prior to the infusion;\n7. Subjects with active hepatitis B (defined as Hepatitis B Virus(HBV) DNA test value\\> 500 IU \u002F mL) or hepatitis C (HCV RNA positive); subjects with HIV positive or treponema pallidum positive;\n8. Subjects with uncontrolled acute life-threatening bacterial, viral, or fungal infection (e. g. positive blood culture 72 hours before infusion);\n9. Subjects with unstable angina pectoris and \u002F or myocardial infarction within the 6 months prior to screening;\n10. Subjects with concurrent or previously diagnosed with other malignancies, except for the patients under following conditions:\n\n    * Well treated basal cells, papillary thyroid carcinoma, squamous cell carcinoma (adequate wound healing is required before enrollment into this study);\n    * Carcinoma in situ of cervical cancer or breast cancer, after curative treatment, showed no signs of recurrence for at least 3 years before the study;\n    * The primary malignancy has been completely removed and is in complete remission for 5 years.\n11. Arrhythmic subjects without medical management control;\n12. Subjects receiving oral anticoagulation within 1 week before JY231 injection infusion;\n13. Having active neurological autoimmune or inflammatory conditions (such as Guillain-Barre syndrome, amyotrophic lateral sclerosis);\n14. Female subjects in pregnant or lactating, or women with planned pregnancy within 2 years after JY231 infusion or male partner with planned pregnancy within 2 years after JY231 infusion;\n15. Subjects with taboo study procedures or other medical conditions that may put them at unacceptable risk according to the investigator's judgment and \u002F or clinical criteria.\n16. Other conditions that the investigator believes that the subjects should not be enrolled in this clinical trial, such as poor compliance.","75 Years",{"count":140,"type":21},[57],"This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed or refractory B cell lymphoma \u002F leukemia. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of relapsed or refractory B cell lymphoma \u002F leukemia.",[166,110],"2025-07-02",{"date":380,"type":36},"2025-07-08",{"date":382,"type":36},"2025-01-20",{"date":384,"type":21},"2026-12-31",{"name":386,"class":179},"Tongji Hospital",{"id":388,"slug":389,"hasResults":11,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":393,"eligibilityCriteria":394,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":395,"enrollmentInfo":396,"targetDuration":4,"studyType":22,"phases":397,"briefSummary":398,"conditions":399,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":403,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":44},"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":140,"type":21},[57],"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.",[400,401,166],"Philadelphia Chromosome Negative","B Cell Acute Lymphoblastic Leukemia (B-ALL)","2025-06-18",{"date":404,"type":36},"2025-06-19",{"date":406,"type":36},"2025-05-12",{"date":408,"type":21},"2027-11-06",{"name":410,"class":179},"University of Chicago",{"id":412,"slug":413,"hasResults":11,"nctId":414,"briefTitle":415,"officialTitle":415,"acronym":416,"eligibilityCriteria":417,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":418,"targetDuration":4,"studyType":22,"phases":420,"briefSummary":421,"conditions":422,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":44},"100586156","phase-1-the-application-of-car-t-cell-therapy-in-relapsed-and-refractory-malignant-hematologic-tumors-100586156","NCT06911710","The Application of CAR-T Cell Therapy in Relapsed and Refractory Malignant Hematologic Tumors","CAR-T","Inclusion Criteria:\n\nWith their own consent and have signed an informed consent form, willing and able to comply with the planned visits, study treatment, laboratory tests and other experimental procedures; Patients with recurrent\u002Frefractory malignant hematologic tumors as determined by clinical diagnosis; Age 18 years and above, both male and female; Subjects with a physical status of 0\\~2 on the Eastern Cooperative Oncology Group (ECOG) score; Expected survival \\>3 months from the date of informed consent; HGB ≥ 60g\u002FL (transfusion is allowed); Liver and kidney function, cardiopulmonary function meet the following requirements: a) creatinine ≤1.5×ULN;b) Left ventricular ejection fraction ≥50%; c) Blood oxygen saturation \\>90%;d) Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN; Subjects with pregnancy plans must agree to use contraception prior to enrollment in the study and after the study has lasted for six months; subjects should notify the investigator immediately if they become pregnant or suspect pregnancy.\n\nSubjects in the different cohorts will still be required to fulfill the following conditions:\n\nLymphoma Cohort:\n\nB-cell lymphoma Diagnosis of CD19+ and\u002For CD20+ and\u002For CD22+ and\u002For BAFF+ B-cell lymphoma confirmed by pathology and histology; Inert B-cell lymphoma (CLL, FL, MZL, LPL, HCL); Aggressive B-cell lymphoma (DLBCL, BL, MCL).\n\nMeet the following criteria for relapsed or refractory B-cell lymphoma (meet 1 of the first 2 plus 3 below):\n\nLess than 50% tumor shrinkage or disease progression after 4 courses of standard regimen regulated chemotherapy; relapse after achieving CR after standard regimen chemotherapy; subjects must have received adequate prior therapy, including at least: Anti-CD20 monoclonal antibody; Anthracycline-containing combination chemotherapy. T-cell lymphoma\n\nDiagnosis of CD7+ refractory\u002Frelapsed T-lymphocyte lymphoma confirmed by pathology and histology, meeting any of the following criteria:\n\nRelapsed: Disease relapse determined after having previously received at least two standardized treatment regimens to achieve complete remission, or disease relapse after having undergone stem cell transplantation to achieve complete remission; Refractory: previous treatment with at least two regimens and failure to achieve complete remission after the last treatment, or failure to achieve remission or disease progression after stem cell transplantation.\n\nII Acute lymphoblastic leukemia cohort:\n\nAcute B-lymphoblastic leukemia Refractory\u002Frelapsed B-lymphoblastic leukemia diagnosed as CD19+ and\u002For CD20+ and\u002For CD22+ and\u002For BAFF+ confirmed by immunohistochemistry or flow cytometry.\n\nRefractory\u002Frelapsed B-lymphoblastic leukemia (meeting 1 of the following 4 criteria is sufficient):\n\nRelapse within 6 months of first remission; first refractory without achieving complete remission with 2 cycles of standard chemotherapy regimen; failure to achieve complete remission or relapse after first or multiple lines of salvage chemotherapy; those who are not suitable for HSCT, or who have abandoned HSCT due to medical constraints, or those who have relapsed after HSCT.\n\nAcute T-lymphoblastic leukemia\n\nDiagnosis of CD7+ refractory\u002Frelapsed T-ALL\u002FLBL confirmed by immunohistochemistry or flow cytometry, meeting any of the following criteria:\n\nNo CR after standard chemotherapy; CR after first treatment, but CR lasted less than 12 months; No CR after first or more remedial therapy; Relapse two or more times.\n\nIII. multiple myeloma cohort:\n\nPositive expression of BCMA and\u002For CD19 and\u002For GPRC5D in myeloma cells by flow or immunohistochemistry; Patients with relapsed\u002Frefractory multiple myeloma who have received at least 1 prior therapy (including proteasome inhibitors (PIs) and immunomodulatory drugs (IMiDs)) or are resistant to proteasome inhibitors and\u002For immunomodulatory agents.\n\nIV. myeloid tumor cohort:\n\nPositive tumor cell antigen test results (CD7 and\u002For CD19 and\u002For CD47) confirmed by immunohistochemistry or flow cytometry; Diagnosis of myeloid tumors, including but not limited to AML and MDS, confirmed by pathology and the patient meets the following\n\nRelapse or refractory requirements:\n\nRelapse: reappearance of leukemic cells in the peripheral blood, or \\>5% of primitive cells found in the bone marrow, or extramedullary relapse after second-line or higher salvage therapy to achieve CR\u002FCRi; Refractory: failure to achieve CR\u002FCRi after at least 2 cycles of standard chemotherapy.\n\nExclusion Criteria:\n\na history of severe cardiac insufficiency with a left ventricular ejection fraction \\\u003C50%; A history of severe lung function-impairing disease; Combination of other malignant tumors in progressive stages; Combination of severe infections that cannot be effectively controlled; Combination of severe autoimmune disease or congenital immunodeficiency; Active hepatitis (Hepatitis B virus deoxyribonucleic acid \\[HBV-DNA\\] or Hepatitis C virus ribonucleic acid \\[HCV-RNA\\] test results above the lower limit of detection); Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection; History of severe allergy to biological products (including antibiotics); Allogeneic hematopoietic stem cell transplantation patients who still have acute graft-versus-host reaction (GvHD) one month after stopping immunosuppressive drugs; Presence of other serious physical or mental illnesses or abnormal laboratory tests that may increase the risk of participation in the study or interfere with the results of the study, as well as patients who, in the opinion of the investigator, are not suitable for participation in this study.",{"count":419,"type":21},90,[24,107],"This study is an open, single-arm, prospective, Phase I\u002FII clinical study using \"3+3\" dose escalation and dose expansion to investigate the safety, maximum tolerated dose, in vivo pharmacokinetic profile, and preliminary efficacy of CAR-T cell injections for the treatment of relapsed\u002Frefractory malignant hematological neoplasms in subjects.",[423,424,425,166,426,427],"Lymphoma, B-cell, Aggressive Non-Hodgkin (B-NHL)","AML (Acute Myelogenous Leukemia)","Myeloma Multiple","T-ALL\u002FLymphoma","T-lymphocyte Lymphoma","2025-04-03",{"date":430,"type":36},"2025-04-04",{"date":432,"type":36},"2024-11-09",{"date":434,"type":21},"2027-02-28",{"name":436,"class":179},"Tianjin Medical University General Hospital",{"id":438,"slug":439,"hasResults":11,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":4,"eligibilityCriteria":443,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":373,"enrollmentInfo":444,"targetDuration":4,"studyType":22,"phases":446,"briefSummary":447,"conditions":448,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":455,"locationsCount":44},"100585412","jy231jy231-injection-for-the-treatment-of-relapsed-or-refractory-b-cell-leukemia-100585412","NCT06902025","JY231(JY231) Injection for the Treatment of Relapsed or Refractory B-Cell Leukemia","An Early Exploratory Clinical Study on the Safety, Tolerability, and Preliminary Efficacy of JY231 Injection in the Treatment of Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia (B-ALL)","Inclusion Criteria:\n\n1. Age 18\\~75 years old, gender is not limited;\n2. Patients with a diagnosis of Cluster of Differentiation 19 positive(CD19+) B-ALL confirmed by flow cytometry or immunohistochemistry according to the criteria of the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2016.v1);\n3. Meet the diagnosis of relapsed\u002Frefractory (relapsed\u002Frefractory) r\u002Fr CD19+ B-ALL, including any of the following:\n\n   A.relapse within 12 months of first remission; B.initial refractory treatment that does not achieve complete remission after two doses of standard chemotherapy, or complete remission or relapse after first-line or multiple lines of salvage therapy;\n\n   C.Patients with Ph+-ALL (Philadelphia chromosome-positive) in whom relapse or refractory is defined as meeting any of the following:\n\n   ① Relapse or refractory after treatment with at least two tyrosine kinase inhibitor (TKI) agents or intolerance to TKI-type agents;\n\n   ② Resistance or failure to achieve remission after receiving second-line TKI therapy;\n\n   ③ Not suitable for TKI therapy;\n4. Bone marrow cytomorphology with \\>5% prolymphocytes + juvenile lymphocytes; or flow Minimal Residual Disease(MRD) \\>=0.01%\n5. Serum total bilirubin ≤ 51 mol\u002FL, serum alanine aminotransferase (ALT) and azelaic transaminase (AST) both ≤ 3 times the upper limit of the normal range, blood creatinine ≤ 176.8 mol\u002FL, and platelets ≥ 20×109\u002FL;\n6. Echocardiography showed left ventricular ejection fraction (LVEF) ≥50%;\n7. Subjects without active pulmonary infection and inspiratory finger pulse oxygen saturation ≥92%;\n8. Subjects have not received radiotherapy, chemotherapy, monotherapy or other anti-ALL therapy within 1 week prior to screening;\n9. Predicted survival of 3 months or more;\n10. Eastern Cooperative Oncology Group(ECOG) score of 0-2;\n11. Subjects or their legal guardians volunteered to participate in this study and signed an informed consent form;\n\nExclusion Criteria:\n\n1. Subjects with active central nervous system (CNS) leukemia;\n2. Subjects with a history of active CNS disease such as seizures, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement;\n3. Subjects who have been treated with another investigational drug within 30 days prior to screening or are still in the washout period;\n4. Subjects who have had radiation therapy within 2 weeks prior to infusion;\n5. Subjects with uncontrolled acute life-threatening bacterial, viral, or fungal infections (e.g., positive blood cultures ≤ 72 hours prior to infusion);\n6. Subjects with unstable angina and\u002For myocardial infarction within 6 months prior to Screening;\n7. Subjects with other prior or concurrent malignancies, with the following exceptions:\n\n   ① Adequately treated basal cell, papillary thyroid, or squamous cell carcinoma (adequate wound healing is required prior to enrollment in the study);\n\n   ② Cancer in situ of the cervix or breast that has been curatively treated and shows no signs of recurrence for at least 3 years prior to study entry;\n\n   ③ primary malignancy that has been completely resected and in complete remission for ≥ 5 years.\n8. Presence of subjects with arrhythmias not controlled by medical management;\n9. Subjects with active neurologic autoimmune or inflammatory conditions (e.g. Guillain-Barre syndrome, amyotrophic lateral sclerosis);\n10. Women who are pregnant or breastfeeding, and female subjects who plan to become pregnant within 2 years of their JY231 injection infusion or male subjects whose partners plan to become pregnant within 2 years of their JY231 injection infusion;\n11. Subjects who, in the investigator's judgment and\u002For clinical criteria, have a contraindication to any of the investigational procedures or have other medical conditions that may place them at unacceptable risk.\n12. Other conditions that, in the opinion of the investigator, should not be enrolled in this clinical study, such as poor compliance.",{"count":445,"type":21},24,[57],"This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed or refractory B cell leukemia. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of relapsed or refractory B-cell Acute Lymphoblastic Leukemia (B-ALL).",[166],"2025-03-24",{"date":451,"type":36},"2025-03-30",{"date":453,"type":21},"2025-03-31",{"date":67,"type":21},{"name":456,"class":179},"He Huang",{"id":458,"slug":459,"hasResults":11,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":4,"eligibilityCriteria":463,"healthyVolunteers":11,"sex":16,"minAge":464,"maxAge":373,"enrollmentInfo":465,"targetDuration":4,"studyType":22,"phases":467,"briefSummary":468,"conditions":469,"keywords":470,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":474,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":44},"100422500","phase-1-a-clinical-research-of-cd19-and-cd22-targeted-prime-car-t-cell-in-relapsedrefractory-b-all-100422500","NCT04781634","a Clinical Research of CD19 and CD22 Targeted Prime CAR-T Cell in Relapsed\u002FRefractory B-ALL","Study Evaluating Safety and Efficacy of CD19 and CD22 Targeted Prime CAR-T Cell in Patients With Relapsed\u002FRefractory B-ALL","Inclusion Criteria:\n\n1. Signed written informed consent\n2. Diagnose as Relapsed and Refractory B -ALL, and meet one of the following conditions:\n\n   1. Failed to standard chemotherapy regimens;\n   2. Relapse after complete remission, high-risk and \u002F or refractory patients ;\n   3. Relapse after hematopoietic stem cell transplantation;\n3. For patients with Ph + ALL, the following conditions must be met: those who have received a standard induction chemotherapy regimen and who have not achieved complete remission after TKI treatment or have relapsed after remission (cannot tolerate TKI treatment or have contraindications to TKI treatment or the presence of TKI class) Except for drug resistant patients)\n4. Evidence for cell membrane CD19 or CD22 expression\n5. All genders ages: 2 to 75 years\n6. The expect time of survive is above 3 months;\n7. KPS\\>60\n8. No serious mental disorders ;\n9. Left ventricular ejection fraction ≥50%\n10. Sufficient hepatic function defined by ALT\u002FAST≤3 x ULN and bilirubin≤2 x ULN;\n11. Sufficient renal function defined by creatinine clearance≤2 x ULN;\n12. Sufficient pulmonary function defined by indoor oxygen saturation≥92%;\n13. With single or venous blood collection standards, and no other cell collection contraindications;\n14. Ability and willingness to adhere to the study visit schedule and all protocol requirements.\n\nExclusion Criteria:\n\n1. Previous history of other malignancy;\n2. Presence of uncontrolled active infection;\n3. Evidence of disorder that need the treatment by glucocorticoids;\n4. Active or chronic GVHD\n5. The patients treatment by inhibitor of T cell\n6. Pregnant or breasting-feeding women;\n7. Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.","2 Years",{"count":466,"type":21},40,[24,107],"This is a single arm study to evaluate the efficacy and safety of CD19 and CD22 targeted prime CAR-T cells therapy for patients with relapsed\u002Frefractory B -ALL",[166],[471,472,416],"CD19","CD22","2025-02-23",{"date":475,"type":36},"2025-02-25",{"date":477,"type":36},"2021-03-07",{"date":479,"type":21},"2027-07-01",{"name":481,"class":258},"Chongqing Precision Biotech Co., Ltd",{"id":483,"slug":484,"hasResults":11,"nctId":485,"briefTitle":370,"officialTitle":486,"acronym":4,"eligibilityCriteria":487,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":373,"enrollmentInfo":488,"targetDuration":4,"studyType":22,"phases":489,"briefSummary":376,"conditions":490,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":497,"locationsCount":44},"100568212","jy231jy231-injection-for-the-treatment-of-relapsed-or-refractory-b-cell-lymphoma-leukemia-100568212","NCT06678282","JY231 Injection for the Treatment of Relapsed or Refractory B Cell Lymphoma\u002F Leukemia - A Safety, Tolerability, and Efficacy Study","Inclusion Criteria：\n\n1. Subject voluntarily sign informed consent and are willing and able to comply with all trial requirements;\n2. Age is 18-75 years old and gender is not limited;\n3. Malignancy cells in bone marrow or peripheral blood are Cluster of Differentiation 19 - positive(CD19+) detected by flow cytometric analysis;\n4. Meet the clinical criteria for relapsed or refractory B-cell lymphoma, including: indolent lymphoma (iNHL), such as follicular lymphoma (FL) and marginal zone lymphoma (MZL); aggressive B-cell lymphoma, like diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed follicular lymphoma (TFL), and T-rich lymphocyte-bearing large B-cell lymphoma (TCRBCL), or have a diagnosis of acute B-lymphocytic leukemia (B-ALL) and meet one of the following conditions:\n\n   * Refractory B-ALL: those who did not achieve complete remission after 2 courses of standard induction regimen chemotherapy, or those who did not achieve complete remission after first-line or multi-line salvage chemotherapy;\n   * Relapsed B-ALL: relapse within 12 months after first remission, or relapse after first-line \u002F multi-line salvage chemotherapy;\n   * Relapse after autologous or allogeneic hematopoietic stem cell transplantation; In addition, patients with Philadelphia chromosome positive (Ph +) should be relapsed after at least two tyrosine kinase inhibitors (TKI) treatment, or they could not tolerate TKI therapy, or have a t315i mutation, resistant to TKI drugs.\n5. Morphological examination of bone marrow cells showed the proportion of primitive and naive lymphocytes was\\> 5%;\n6. No Hematopoietic Stem Cell Transplantation(HSCT) within 6 months before enrollment;\n7. At least one measurable lesion was imaging for relapsed or refractory B cell lymphoma, long diameter of\\> 15mm, or extranodal lesion of\\> 10mm, along with a positive Positron Emission Tomography - Computed Tomography(PET-CT) examination.\n8. More than 12 weeks of expected survival period\n9. Baseline Eastern Cooperative Oncology Group(ECOG) score was 0-1;\n10. Adequate organ function (criteria regarding liver and kidney function can be moderately relaxed):\n\n    * Glutamic aminotransferase (ALT) ≤3 times upper limit of normal (ULN);\n    * Grass aminotransferase (AST) ≤3 times ULN;\n    * Total bilirubin ≤1.5 times ULN;\n    * Serum creatinine ≤ 1.5 times ULN, or creatinine clearance ≥ 60 mL\u002Fmin;\n    * Indoor oxygen saturation ≥ 92%;\n    * Left ventricular ejection fraction (LVEF)≥55%, echocardiography confirmed no pericardial effusion and no clinically significant ECG findings;\n    * There is no clinically significant pleural effusion;\n11. Adequate bone marrow reserve without transfusion, defined as:\n\n    * Absolute neutrophil count (ANC)\\>1.000 \u002F mm3;\n    * Absolute lymphocyte count (ALC)≥ 300 \u002F mm3;\n    * Platelet≥50.000\u002Fmm3;\n    * Hemoglobin\\>8.0 g\u002Fdl;\n12. Subjects using the following drugs need to meet the following conditions:\n\n    * Steroids: The therapeutic dose of steroids must be stopped 72 hours before JY231 infusion. However, physiological alternative doses of steroids are allowed;\n    * Immunosuppression: Any immunosuppressive drug must be stopped at ≥4 weeks prior to enrollment;\n    * Antiproliferative therapy other than lymphodepletion chemotherapy within two weeks of infusion;\n    * Cluster of Differentiation 20(CD20) antibody-related therapy must be stopped within 4 weeks before infusion or 5 half-lives after the CD20 antibody;\n    * CNS disease prophylaxis must be stopped 1 week before JY231 infusion (e. g. intrathecal methotrexate).\n\nReproductive men, sexual partners ensure effective contraception; fertile women, adopted effective contraception and agreed to use contraception throughout the study period.\n\nExclusion Criteria：\n\n1. Subjects with active cerebrospinal fluid malignant cells or brain metastases, or subjects with active central nervous system (CNS) lymphoma, or CNS leukaemia;\n2. Subjects with a history of active CNS disease, such as seizures, cerebrovascular ischemia \u002F hemorrhage, dementia, cerebellar disease, or any autoimmune disease associated with CNS involvement;\n3. Subjects who have received other study drugs within 30 days before screening, or are still in the washout period;\n4. Patients who have previously received any anti-CD19 \u002F anti-Cluster of Differentiation 3(CD3) therapy or any other anti-CD19 therapy (except for those with normal T cell numbers and function and with CD19-positive tumors);\n5. Patients who have been previously treated with any gene therapy product, including Chimeric Antigen Receptor T(CAR-T) therapy (except patients who do not have CAR-T cells in vivo and have normal T cell number and function and are with CD19 positive tumors);\n6. Subjects with radiation therapy within 2 weeks prior to the infusion;\n7. Subjects with active hepatitis B (defined as Hepatitis B Virus(HBV) DNA test value\\> 500 IU \u002F mL) or hepatitis C (HCV RNA positive); subjects with HIV positive or treponema pallidum positive;\n8. Subjects with uncontrolled acute life-threatening bacterial, viral, or fungal infection (e. g. positive blood culture 72 hours before infusion);\n9. Subjects with unstable angina pectoris and \u002F or myocardial infarction within the 6 months prior to screening;\n10. Subjects with concurrent or previously diagnosed with other malignancies, except for the patients under following conditions:\n\n    * Well treated basal cells, papillary thyroid carcinoma, squamous cell carcinoma (adequate wound healing is required before enrollment into this study);\n    * Carcinoma in situ of cervical cancer or breast cancer, after curative treatment, showed no signs of recurrence for at least 3 years before the study;\n    * The primary malignancy has been completely removed and is in complete remission for 5 years.\n11. Arrhythmic subjects without medical management control;\n12. Subjects receiving oral anticoagulation within 1 week before JY231 injection infusion;\n13. Having active neurological autoimmune or inflammatory conditions (such as Guillain-Barre syndrome, amyotrophic lateral sclerosis);\n14. Female subjects in pregnant or lactating, or women with planned pregnancy within 2 years after JY231 infusion or male partner with planned pregnancy within 2 years after JY231 infusion;\n15. Subjects with taboo study procedures or other medical conditions that may put them at unacceptable risk according to the investigator's judgment and \u002F or clinical criteria.\n\nOther conditions that the investigator believes that the subjects should not be enrolled in this clinical trial, such as poor compliance.",{"count":140,"type":21},[57],[110,166],"2024-11-06",{"date":493,"type":36},"2024-11-07",{"date":495,"type":36},"2023-09-07",{"date":384,"type":21},{"name":498,"class":258},"Shenzhen Genocury Biotech Co., Ltd.",{"id":500,"slug":501,"hasResults":11,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":4,"eligibilityCriteria":505,"healthyVolunteers":11,"sex":16,"minAge":506,"maxAge":4,"enrollmentInfo":507,"targetDuration":4,"studyType":22,"phases":508,"briefSummary":509,"conditions":510,"keywords":511,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":514,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":4},"100566727","blinatumomab-as-maintenance-therapy-in-patients-with-high-risk-b-lineage-acute-lymphoblastic-leukemia-post-allogeneic-hematopoietic-cell-transplantation-100566727","NCT06658938","Blinatumomab as Maintenance Therapy in Patients With High-risk B-lineage Acute Lymphoblastic Leukemia Post Allogeneic Hematopoietic Cell Transplantation","A Prospective, Single-arm Clinical Study of Blinatumomab in the Maintenance Treatment of High-risk Patients With Acute B-lymphoblastic Leukemia After Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n* 1．Age ≥ 14 years, male or female; 2．CD19 + acute B lymphoblastic leukemia treated with allogeneic hematopoietic stem cell transplantation \\[Patients, the types of transplantation include fully matched sibling transplantation, haploidentical related donor transplantation and unrelated donor transplantation; 3．CD19 + acute B-lymphoblastic leukemia at risk of relapse before transplantation \\[including but not limited to: refractory leukemia: failure to achieve complete remission (CR)\u002FCR with partial hematological recovery (CRh)\u002FCR with incomplete hematological recovery (CRi) or CR\u002FCRh\u002FCRi after the end of induction therapy (generally refers to 4-week regimen or Hyper-CVAD regimen), but still positive for measurable residual disease (MRD); relapsed leukemia: patients who have achieved CR have blasts in peripheral blood or bone marrow (proportion \\> 5%), or extramedullary disease; onset of white blood cells \\> 30 × 109\u002FL; patients with poor prognosis cytogenetic abnormalities; patients with positive residual leukemia before transplantation, etc.\\] 4．The disease is in complete remission, and residual leukemia is negative, absolute neutrophil count ≥ 1.0 × 109\u002FL, platelet count ≥ 50 × 109\u002FL, lasting for more than a week; 5．Freedom from ≥ Grade 3 acute GVHD or uncontrolled moderate to severe chronic GVHD within 30 days prior to enrollment; Awareness and willingness to sign written informed consent.\n\nExclusion Criteria:\n\n* 1.Patients with hematological relapse or minimal residual disease relapse of B-ALL after transplantation; 2.Presence of serious uncontrolled active infection (e.g., sepsis, pulmonary infection, etc.).\n\n  3.Markedly abnormal screening laboratory tests: A) Alanine aminotransferase (ALT) ≥ 5 × ULN (upper limit of normal); B) Aspartate aminotransferase (AST) ≥ 5 × ULN; C) Total bilirubin (TBIL) ≥ 3 × ULN; D) Creatinine clearance \\\u003C 70 mL\u002Fmin at screening; Patients with active hepatitis B (hepatitis B surface antigen positive and peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥ 1 × 102 copies\u002FmL); F) Hepatitis C antibody positive; G) Human immunodeficiency virus (HIV) positive; h) Treponema pallidum antibody positive; 4.ECOG performance status ≥ 3 5.Estimated survival less than 3 months This study may not be completed for other reasons, or the investigator considers it inappropriate to participate in this study.","14 Years",{"count":355,"type":21},[57],"Patients ≥ 14 years of age after B-ALL allogeneic transplantation received 4 cycles of maintenance therapy with blinatumomab +\u002F- TKI and were followed for more than 1 year to assess overall survival (OS), relapse-free survival (RFS), incidence of acute and chronic GVHD, safety, etc.",[166],[512],"allogeneic hematopoietic stem cell transplantation","2024-10-23",{"date":515,"type":36},"2024-10-26",{"date":517,"type":21},"2024-11-01",{"date":519,"type":21},"2026-10-01",{"name":521,"class":179},"Institute of Hematology & Blood Diseases Hospital, China",{"id":523,"slug":524,"hasResults":11,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":4,"eligibilityCriteria":528,"healthyVolunteers":11,"sex":16,"minAge":506,"maxAge":4,"enrollmentInfo":529,"targetDuration":4,"studyType":22,"phases":530,"briefSummary":531,"conditions":532,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":534,"startDateStruct":536,"completionDateStruct":538,"leadSponsor":540,"locationsCount":4},"100554830","the-use-of-blinatumomab-in-patients-with-ngs-mrd-relapsed-b-all-after-autologousallogeneic-transplantation-100554830","NCT06504186","The Use of Blinatumomab in Patients With NGS-MRD Relapsed B-ALL After Autologous\u002FAllogeneic Transplantation","A Prospective, Single-arm Clinical Study of the Use of Blinatumomab in Patients With NGS-MRD Relapsed B-ALL After Autologous\u002FAllogeneic Transplantation","Inclusion Criteria:\n\n* 1.CD19 + acute B-lymphoblastic leukemia (Ph- or Ph + ALL); 2.Age ≥ 14 years, male or female 3.B-ALL includes any of the following:\n\n  1. The cytogenetic prognosis of adult acute B lymphoblastic leukemia in accordance with NCCN 2023 at initial diagnosis was divided into poor prognosis group;\n  2. Patients with relapsed and refractory ALL and MRD-positive ALL before transplantation,\n\n  \u003C!-- -->\n\n  1. Refractory ALL is one of the following conditions. A）Failure to achieve CR\u002FCRi at the end of induction therapy (generally referred to as 4-week regimen or Hyper-CVAD regimen).\n  2. Relapsed ALL is defined as the appearance of blasts in the peripheral blood or bone marrow (\\> 5%), or the development of extramedullary disease in patients who have achieved CR.\n  3. A positive MRD before transplantation is one of the following conditions. A）Proportion of abnormal blasts \\> 0.01% by flow cytometry within 45 days prior to transplantation B）Positive molecular biology related tests before transplantation; 4.NGS-IGH Conspicuous Clonal Sequences Collected (Timepoint: At initial diagnosis or prior to transplant) 5.MRD relapse (≥ 10-6, IGH-VDJ rearrangement by NGS) and \\\u003C 5% bone marrow blasts at 3 and 6 months post auto\u002Fallo HSCT 6.ECOG score of 0 or 1\u002F≤ 2 7.Adequate organ function (ALT\u002FAST \\\u003C 5 x upper limit of normal (ULN), serum bilirubin \\\u003C 3.0 x ULN, creatinine clearance \\> 30ml\u002Fmin) 8.Negative test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), and hepatitis C virus (anti-HCV) 9.Negative pregnancy test for women of childbearing potential 10.Awareness and willingness to sign written informed consent\n\nExclusion Criteria:\n\n\\- Subjects who met any of the following criteria were not to be enrolled in the study: 6.CNSL or other extramedullary involvement after transplantation, other malignancies 7.Relevant central nervous system pathology (eg, seizure, paresis, aphasia, cerebrovascular ischemia\u002Fhemorrhage, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, or coordination or dyskinesia) 8.Co-infection active 9.Concomitant active GVHD requiring treatment 10.Product component allergy 11.Treatment with an investigational product 4 weeks prior to treatment",{"count":140,"type":21},[57],"To explore the efficacy and safety ofblinatumomab± TKI in B-ALL patients aged ≥ 14 years with NGS-MRD relapse (sensitivity: 10-6) after auto\u002Fallo HSCT, and to observe the disease-free survival (DFS), recurrence rate and toxicity after transplantation.",[166],"2024-07-10",{"date":535,"type":36},"2024-07-16",{"date":537,"type":21},"2024-07",{"date":539,"type":21},"2026-10",{"name":521,"class":179}]