[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"UCARsgen Biotech Limited\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100651379","phase-1-a-clinical-study-of-ct0596-car-t-in-relapsedrefractory-multiple-myeloma-100651379",false,"NCT07760454","A Clinical Study of CT0596 CAR-T in Relapsed\u002FRefractory Multiple Myeloma","A Phase I\u002FII Clinical Trial to Evaluate the Safety, Efficacy, and Cellular Kinetics of CT0596 CAR-T Cell Injection in Patients With Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\n* Voluntarily participate in the trial; fully understand and sign the informed consent form (ICF); willing and able to comply with all trial procedures.\n* Age ≥ 18 years, male or female.\n* Patients with relapsed\u002Frefractory multiple myeloma (R\u002FR MM) who have received at least 3 prior lines of therapy, including at least one proteasome inhibitor (PI), at least one immunomodulatory agent (IMiD), and at least one anti-CD38 monoclonal antibody.\n* Relapsed\u002Frefractory disease defined per IMWG 2016 response criteria,.\n* Must have measurable disease:\n* Life expectancy ≥ 12 weeks.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Must have Adequate organ function\n* Female participants of childbearing potential must have a negative pregnancy test at screening and prior to lymphodepletion, and must agree to use highly effective contraception for at least 1 year after CT0596 infusion, and absolutely refrain from oocyte donation. Male participants with active sexual life with WOCBP must agree to use highly effective contraception for at least 1 year after infusion and absolutely refrain from sperm donation。\n\nExclusion Criteria:\n\n* Pregnant or lactating women.\n* Positive for HIV, syphilis, active hepatitis B (HBV-DNA above LLoD), or active hepatitis C (positive for both HCV antibody and HCV-RNA).\n* Presence of any uncontrolled active infection, including but not limited to active tuberculosis (per investigator), active CMV and\u002For EBV infection, etc.\n* Toxicity from prior therapy not recovered to ≤ Grade 1 per Common Terminology Criteria for Adverse Events(CTCAE) V5.0 (except alopecia and other events deemed tolerable by the investigator).\n* Prior BCMA-targeted therapy (refer to the protocol for exceptions).\n* Prior allogeneic stem cell transplantation; or autologous SCT within 3 months prior to signing ICF; or planned Hematopoietic Stem Cell Transplantation(HSCT) during the trial.\n* Received disease-directed therapy within 14 days or 5 half-lives (whichever is shorter) prior to lymphodepletion.\n* Received any cell therapy within 6 months prior to ICF; or prior CAR-T with best response \\\u003C PR.\n* Received systemic corticosteroids equivalent to \\> 15 mg\u002Fday of prednisone within 7 days prior to lymphodepletion (excluding topical use).\n* Received live-attenuated, inactivated, or RNA vaccines within 4 weeks prior to lymphodepletion.\n* Major surgery within 2 weeks prior to lymphodepletion, or planned major surgery during trial or within 4 weeks after treatment (excluding local anesthesia surgeries).\n* Allergy or intolerance to lymphodepletion agents, tocilizumab, or any component of infusion (e.g., DMSO); or history of severe allergy such as anaphylactic shock.\n* Diagnosed with secondary plasma cell leukemia, solitary extramedullary plasmacytoma, Waldenström macroglobulinemia, POEMS syndrome, or primary light chain amyloidosis at screening.\n* Severe cardiac diseases within 6 months prior to screening.\n* Severe pulmonary disease that may jeopardize the patient's life per investigator.\n* Inability to tolerate an adequate lymphodepletion regimen.\n* Secondary primary malignancy requiring treatment or not in complete remission within 2 years prior to screening, except for successfully treated non-metastatic basal\u002Fsquamous cell skin carcinoma, non-metastatic prostate cancer, carcinoma in situ (breast\u002Fcervix), non-muscle-invasive bladder cancer, or low-grade thyroid cancer.\n* Known symptomatic central nervous system (CNS) disease or suspected CNS metastasis.\n* Patients assessed by the investigator as unable or unwilling to comply with protocol requirements, or otherwise unsuitable for participation.","ALL","18 Years",{"count":19,"type":20},68,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a Phase I\u002FII, single-arm, open-label, multicenter clinical trial in patients with relapsed\u002Frefractory multiple myeloma (R\u002FR MM). The study aims to evaluate the safety, tolerability, efficacy, cellular kinetics, and immunogenicity of CT0596.",[27],"Relapsed\u002FRefractory Multiple Myeloma","NOT_YET_RECRUITING","2026-08-09",{"date":31,"type":32},"2026-08-12","ACTUAL",{"date":34,"type":20},"2026-09-01",{"date":36,"type":20},"2031-04-30",{"name":38,"class":39},"UCARsgen Biotech Limited","OTHER",2,""]