[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"t-alllymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:t-alllymphoma":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100586156","phase-1-the-application-of-car-t-cell-therapy-in-relapsed-and-refractory-malignant-hematologic-tumors-100586156",false,"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.","ALL","18 Years",{"count":19,"type":20},90,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","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.",[27,28,29,30,31,32],"Lymphoma, B-cell, Aggressive Non-Hodgkin (B-NHL)","AML (Acute Myelogenous Leukemia)","Myeloma Multiple","B-ALL","T-ALL\u002FLymphoma","T-lymphocyte Lymphoma","RECRUITING","2025-04-03",{"date":36,"type":37},"2025-04-04","ACTUAL",{"date":39,"type":37},"2024-11-09",{"date":41,"type":20},"2027-02-28",{"name":43,"class":44},"Tianjin Medical University General Hospital","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":72,"leadSponsor":74,"locationsCount":45},"100585984","phase-1-clinical-trial-of-cd5-targeted-car-nk-therapy-for-relapserefractory-t-cell-hematologic-malignancies-100585984","NCT06909474","Clinical Trial of CD5-targeted CAR-NK Therapy for Relapse\u002FRefractory T-Cell Hematologic Malignancies","Clinical Study of CD5 Targeting Chimeric Antigen Receptor NK Cells (CAR-NK) in the Treatment of Relapse\u002FRefractory T-Cell Hematologic Malignancies","Inclusion Criteria:\n\n\\-\n\n1.Gender and Age: No gender restriction; age 18-75 years (inclusive). 2.Diagnosis: Confirmed diagnosis of T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoma, including:\n\n1. T-ALL Patients: Bone marrow morphology during screening shows ≥5% blasts\u002Fimmature lymphocytes and\u002For flow cytometry confirms minimal residual disease (MRD)+, and meets any of the following:\n\n   1. Refractory to ≥2 cycles of standard induction chemotherapy (failure to achieve CR).\n   2. Relapsed within 12 months after achieving CR with first-line induction therapy.\n   3. Failure to achieve CR or relapse after ≥2 lines of chemotherapy.\n   4. Relapse after hematopoietic stem cell transplantation (HSCT).\n2. T-cell Lymphoma Patients: Confirmed diagnosis of T-lymphoblastic lymphoma (T-LBL) or T-cell non-Hodgkin lymphoma (including but not limited to: peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell lymphoma (ALCL), extranodal NK\u002FT-cell lymphoma (ENKL), T-cell prolymphocytic leukemia (T-PLL), adult T-cell leukemia\u002Flymphoma (ATLL), mycosis fungoides\u002FSézary syndrome (MF\u002FSS) stage IIB or higher), and meets both:\n\n   1. At least one bidimensionally measurable lesion per Lugano 2014 criteria: nodal lesions \\>1.5 cm in long axis; extranodal lesions \\>1.0 cm in long axis.\n   2. Refractory to ≥2 lines of chemotherapy, primary resistance, or relapse post-HSCT.\n\n      3.CD5 Positivity: Confirmed by flow cytometry (≥80% tumor cells express CD5 with mean fluorescence intensity \\[MFI\\] equivalent to normal T cells; Dim defined as MFI ≥1 log lower than normal T cells; partial positivity defined as 20-80% tumor cells expressing CD5) or immunohistochemistry (\\>30% tumor cells express CD5).\n\n      4.ECOG Performance Status: 0-2 . 5.Life Expectancy: ≥12 weeks. 6.Organ Function:\n\n   \u003C!-- -->\n\n   1. Cardiac: Left ventricular ejection fraction (LVEF) ≥50% by echocardiography; no significant ECG abnormalities.\n   2. Renal: Serum creatinine ≤2.0×ULN.\n   3. Hepatic: ALT\u002FAST ≤3.0×ULN (≤5.0×ULN if liver involvement); total bilirubin ≤2.0×ULN.\n   4. Pulmonary: Oxygen saturation ≥92% (room air). 7.No Contraindications: To leukapheresis, venipuncture, or cell collection. 8.No Severe Psychiatric Disorders. 9.Contraception: Agreement to use effective contraception from informed consent until 1 year post-CAR-NK infusion (for patients of childbearing potential).\n\n      10.Informed Consent: Signed by the patient or legal guardian, confirming understanding of the trial's purpose and procedures.\n\nExclusion Criteria:\n\n1. Prior CAR-NK therapy or genetically modified cell therapy.\n2. Active CNS involvement at screening (prior CNS involvement with resolved status post-treatment is allowed).\n3. Recent Anticancer Therapy:\n\n   1. Chemotherapy, targeted therapy, or investigational drugs within 2 weeks or 5 half-lives prior to screening.\n   2. Radiotherapy within 2 weeks prior to screening.\n4. Active\u002FUncontrolled Infection: Within 1 week prior to screening.\n5. Cerebrovascular Event or Seizure: Within 6 months prior to screening.\n6. Viral Infections:\n\n   1. HBV DNA \\> ULN (if HBsAg+ or HBcAb+).\n   2. HCV RNA \\> ULN (if HCV Ab+).\n   3. HIV+, syphilis+, or active tuberculosis.\n7. Cardiac Disease:\n\n   1. NYHA Class III\u002FIV congestive heart failure.\n   2. Myocardial infarction or CABG ≤6 months prior.\n   3. Clinically significant ventricular arrhythmia or unexplained syncope (excluding vasovagal\u002Fdehydration-related).\n   4. Severe cardiomyopathy.\n8. Active\u002FUncontrolled Autoimmune Disease.\n9. Prior Malignancy: Within 5 years, except for cured cervical carcinoma in situ, basal\u002Fsquamous skin cancer, localized prostate cancer, or ductal carcinoma in situ.\n10. Live Vaccination: Within 4 weeks prior to screening.\n11. Pregnancy\u002FLactation: Pregnant, breastfeeding, or planning pregnancy within 1 year post-CAR-NK infusion.\n12. Other: Investigator-determined ineligibility.","75 Years",{"count":55,"type":20},15,[23],"This is a clincal trial initiated by investigator to evaluate the safety and efficacy of anti-CD5 CAR-NK in the treatment of patients with relapsed\u002Frefractory T-Cell hematologic malignancies.",[31],[60,61,62,63,64,65,66,67,68],"T-ALL","T-LBL","PTCL-NOS","AITL","ALCL","ENKL","T-PLL","ATLL","MF\u002FSS","2025-03-27",{"date":34,"type":37},{"date":69,"type":37},{"date":73,"type":20},"2028-03-31",{"name":75,"class":76},"Chongqing Precision Biotech Co., Ltd","INDUSTRY"]