[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"b-acute-lymphoblastic-leukemialymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:b-acute-lymphoblastic-leukemialymphoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100634432","phase-1-evaluation-of-the-safety-and-efficacy-of-sup19-car-t-cells-in-patients-with-previously-failed-cd19-targeted-therapy-or-cd19-weakly-expressed-hematologic-tumors-100634432",false,"NCT07539610","Evaluation of the Safety and Efficacy of Sup19 CAR-T Cells in Patients With Previously Failed CD19-Targeted Therapy or CD19-Weakly Expressed Hematologic Tumors","Evaluation of the Safety and Efficacy of Sup19 CAR-T Cells in Patients With Previously Failed CD19-Targeted Therapy or CD19-Weakly Expressed Hematologic Tumors: A Prospective, Single-Arm Clinical Study","Inclusion Criteria:\n\n* Patients aged ≥18 and \\\u003C70 years, of any gender;\n* diagnosed with B-ALL\u002FLBL according to the criteria of the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2020.v1) and B-cell Lymphoma Clinical Practice Guidelines (2020.v1);\n* meeting either of the following two criteria: (1) Previous targeted CD19 therapy, including bispecific antibodies, ADC drugs, and CAR-T, with continued CD19 expression; (2) Patients with hematological malignancies who have not received CD19-targeted therapy in the past, with weakly positive CD19 expression;\n* At the time of screening, the number of blasts in the bone marrow is 25% (bone marrow morphology) and\u002For extramedullary lesions;\n* Meeting the diagnosis of relapsed\u002Frefractory B-ALL\u002FLBL, including any of the following situations: a. Primary refractory patients who have not achieved complete remission after two cycles of standardized chemotherapy or patients who have not achieved complete remission after multiple salvage chemotherapy regimens; b. Patients who relapse within 12 months after achieving complete remission or relapse after 12 months of achieving complete remission and have not achieved complete remission after one or more courses of standard treatment induction; c. Patients who relapse after hematopoietic stem cell transplantation or after CAR-T therapy targeting the same target;\n* Other relapsed\u002Frefractory CD19 weakly expressing hematological malignancies;\n* Creatinine clearance rate \\> 60 ml\u002Fmin (Cockcroft and Gault formula); for patients without liver involvement, total serum bilirubin \\\u003C 3 times the upper limit of normal, and both serum ALT and AST \\\u003C 5 times the upper limit of the normal range.\n* Echocardiography shows left ventricular ejection fraction (LVEF) of 250%;\n* Finger pulse oxygen saturation \\> 92%;--Estimated survival period of more than 3 months;\n* Estimated survival period of more than 3 months;\n* ECOG score of 0-2;\n* The subject or his\u002Fher legal guardian voluntarily participates in this trial and signs the informed consent form.\n\nExclusion Criteria:\n\n* Acute promyelocytic leukemia (APL);\n* presence of hereditary syndromes such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known myelodysplastic syndrome;\n* uncontrolled active central nervous system leukemia (CNSL), i.e., cerebrospinal fluid (CSF) classification CNS 3;\n* prior administration of antineoplastic therapy before infusion; exclusion criteria include: a. Received systemic chemotherapy within 1 week (excluding pre-treatment); b. Those who have received monoclonal antibody treatment, with the time from the last monoclonal antibody infusion to the screening being less than 5 half-lives or 4 weeks (whichever is shorter); c. Received donor lymphocyte infusion (DLI) within 6 weeks;\n* Had uncontrolled severe active infection at screening;\n* Had a history of severe heart disease, including: severe heart dysfunction (according to the New York Heart Association (NYHA) cardiac function classification criteria, subjects with grade III or V cardiac dysfunction), myocardial infarction within 12 months or undergoing coronary angioplasty or stent placement, unstable angina pectoris, or electrocardiogram indicating a significantly prolonged QT interval (\\>480ms) or the investigator determined severe arrhythmia;\n* Had a history of head trauma, consciousness disorder, epilepsy, cerebrovascular ischemia, or cerebrovascular hemorrhagic disease, and required medication within the past 6 months;\n* Had hepatitis B surface antigen (HBsAg) greater than 10E6 IU\u002FmL at screening; positive hepatitis C virus (HCV) antibody; positive human immunodeficiency virus (HIV) antibody; positive syphilis antibody; EBER positive or EBV copy number \\> upper limit of normal;\n* Those who require the use of steroid hormones during CAR-T infusion (except for those using inhaled steroid hormones locally); subjects who are receiving systemic steroid treatment before screening and whose study investigators determine that they need long-term systemic steroid treatment during the treatment period (excluding those using inhaled or local steroid hormones);\n* Subjects with treatable autoimmune diseases, immunodeficiency or those requiring immunosuppressive therapy;\n* Subjects who had acute graft-versus-host disease (GvHD) or moderate to severe chronic GvHD within 4 weeks before screening;\n* Subjects with a history of allergy to any component of the cell product;\n* Pregnant or lactating women, as well as male or female subjects who have reproductive capacity and cannot take effective contraceptive measures within 1 year after cell infusion (regardless of gender); male subjects who plan to conceive within 1 year after cell infusion; female subjects or their partners who plan to conceive within 1 year after cell infusion;\n* Any situation that the investigator considers may increase the risk for the subject or interfere with the test results.","ALL","18 Years","69 Years",{"count":20,"type":21},9,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","Evaluation of Sup19 CAR-T cells in cases where previous CD19-targeted therapy has failed or where CD19 Evaluation of Safety and Efficacy in the Treatment of Low-Grade Hematological Malignancies: A Prospective, Single-Arm Clinical Study Research",[27,28],"B-Acute Lymphoblastic Leukemia","B Acute Lymphoblastic Leukemia\u002FLymphoma","NOT_YET_RECRUITING","2026-04-13",{"date":32,"type":33},"2026-04-20","ACTUAL",{"date":35,"type":21},"2026-04",{"date":37,"type":21},"2027-11",{"name":39,"class":40},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":41},"100601150","phase-1-cd180-cart-for-relapsed-or-refractory-cd180-positive-hematologic-malignancies-100601150","NCT07106749","CD180 CART for Relapsed or Refractory CD180 Positive Hematologic Malignancies","CD180 CART Cell Injection in the Treatment of Relapsed or Refractory CD180 Positive Hematologic Malignancies: a Prospective, Single-arm, Single-center Clinical Study.","Inclusion Criteria:\n\n1. Age ≥18 and \\\u003C70 years, regardless of gender;\n2. B-ALL\u002FLBL was diagnosed according to the criteria of NCCN Clinical Practice Guidelines for Acute Lymphocytic Leukemia (2020.v1) and B-cell Lymphoma Clinical Practice Guidelines (2020.v1);\n3. Patients diagnosed with AML with reference to the Guidelines for Diagnosis and Treatment of Adult Acute Myeloid Leukemia (2018 Edition) issued by the Health Commission;\n4. Cytology confirmed that the tumor cells were CD180 positive.\n5. Number of blasts in bone marrow ≥5% at screening (bone marrow morphology);\n6. Complies with the diagnosis of relapsed\u002Frefractory AML, including any of the following conditions according to China Guidelines for Diagnosis and Treatment of Relapsed\u002FRefractory Acute Myeloid Leukemia (2021 Edition):\n\n   1. Primary refractory patients who did not achieve CR after two cycles of standard induction chemotherapy;\n   2. CR after consolidation chemotherapy, relapse within 12 months;\n   3. Relapse 12 months after remission but ineffective after conventional chemotherapy;\n   4. 2 or more relapses;\n   5. Relapse after hematopoietic stem cell transplantation.\n7. Meet the diagnosis of relapsed\u002Frefractory B-ALL\u002FLBL, including any of the following:\n\n   1. Primary refractory patients who have not achieved complete response after two cycles of standard chemotherapy, or patients who have not achieved complete response after multi-line rescue chemotherapy;\n   2. Relapse within \\\u003C12 months after complete remission or ≥12 months after complete remission and fail to achieve complete remission induced by 1 or more cycles of standard treatment;\n   3. Relapse after hematopoietic stem cell transplantation or relapse after CAR-T therapy at the same target;\n8. Complies with diagnosis of other relapsed\u002Frefractory CD180 positive hematologic malignancies\n9. Creatine clearance \\>60ml\u002Fmin (Cockcroft and Gault formula); serum total bilirubin ≤3 times the upper limit of normal, serum ALT and AST ≤5 times the upper limit of normal range for patients without liver invasion;\n10. Echocardiography showing left ventricular ejection fraction (LVEF) ≥50%;\n11. Pulse oxygen saturation ≥92%;\n12. The estimated survival time is more than 3 months;\n13. ECOG score 0-2;\n14. Subjects or their legal guardians voluntarily participate in this trial and sign the informed consent form.\n\nExclusion Criteria:\n\nSubjects who met any of the following criteria were excluded from the study:\n\n1. acute promyelocytic leukemia (APL);\n2. Presence of a genetic syndrome such as Fanconi's anemia, Kostmann's syndrome, Shwachman syndrome or any other known syndrome of bone marrow failure;\n3. Patients with uncontrolled active central nervous system leukemia (CNSL), i.e. cerebrospinal fluid grades CNS 2 and CNS 3;\n4. Patients who have received anti-tumor therapy before infusion should be excluded if any of the following conditions are met:\n\n   1. Systemic chemotherapy (except for pretreatment) within 1 week;\n   2. For those who have received monoclonal antibody therapy, the last time of monoclonal antibody infusion is less than 5 half-lives or 4 weeks (whichever is shorter) at screening;\n   3. Received donor lymphocyte infusion (DLI) within 6 weeks;\n5. Presence of uncontrolled, serious, active infection at screening;\n6. Patients with a history of serious heart disease, including: severe cardiac insufficiency (subjects with cardiac insufficiency of Class III or IV according to the New York Heart Association (NYHA) cardiac function classification standard), myocardial infarction within 12 months or cardiac angioplasty or stenting, unstable angina pectoris, ECG indicating significant QT interval prolongation (\\>480ms) or serious arrhythmia judged by the investigator;\n7. Previous craniocerebral trauma, disturbance of consciousness, epilepsy, cerebral ischemia, cerebral vascular hemorrhagic disease and other medical history, and within six months of the need for drug treatment;\n8. Patients with hepatitis B surface antigen (HBsAg) greater than 10E6 IU\u002FmL, hepatitis C virus (HCV) antibody positive, human immunodeficiency virus (HIV) antibody positive, syphilis antibody test positive, EBER positive or EBV copy number greater than the upper limit of normal at screening;\n9. Patients who must use steroid hormones during CAR-T infusion (except for local or inhaled steroid hormones); subjects who are receiving systemic steroid therapy before screening and need long-term systemic steroid therapy during treatment according to the investigator's judgment (except for inhaled or local use);\n10. Subjects with autoimmune diseases requiring treatment, immunodeficient subjects, or subjects requiring immunosuppressive treatment;\n11. Patients with acute graft-versus-host disease (GvHD) or moderate-to-severe chronic GvHD within 4 weeks prior to screening;\n12. Patients with a history of allergy to any component of cell products;\n13. Pregnant, lactating females, and subjects (male or female) of childbearing potential who are unable to use effective contraception within 1 year after cell infusion; male subjects who plan to become pregnant within 1 year after cell infusion; female subjects or partners who plan to become pregnant within 1 year after cell infusion;\n14. Any condition that, in the opinion of the investigator, may increase the risk to the subject or interfere with the results of the trial.","70 Years",{"count":51,"type":21},12,[24],"The objective of this study was to evaluate the safety and efficacy of CD180 CART cells in the treatment of patients with relapsed\u002Frefractory CD180-positive hematological malignancies. In this single-arm, open-label, single-center, Phase I clinical trial, two cohorts were set up: (1) relapsed and refractory AML cohort; and (2) relapsed and refractory B-ALL\u002FLBL cohort. CD180 CART cells will be administered intravenously using a 3+3 dose escalation and rapid titration design, with CART dose groups of (1) 0.5×10\\^6 CART cells\u002Fkg;(2)1×10\\^6 CART cells\u002Fkg; and (3) 3×10\\^6 CART cells\u002Fkg. Each cohort was planned to enroll 6-12 patients.",[55,28],"Acute Myeloid Leukemia",[57,58,59,60,61],"CD180 CAR-T","Acute myeloid leukemia (AML)","B acute lymphoblastic leukemia\u002Flymphoma (B-ALL\u002FLBL)","Prospective study","Single-arm Clinical Study","RECRUITING","2025-07-30",{"date":65,"type":33},"2025-08-06",{"date":67,"type":33},"2025-06-28",{"date":69,"type":21},"2030-06-28",{"name":39,"class":40}]