Tests CT0596 CAR-T cell therapy in people with relapsed multiple myeloma

Trial details

Who runs it

UCARsgen Biotech Limited

Trial code

NCT07760454

Record updated

17 September 2026

Original description

This is a Phase I/II, single-arm, open-label, multicenter clinical trial in patients with relapsed/refractory multiple myeloma (R/R MM). The study aims to evaluate the safety, tolerability, efficacy, cellular kinetics, and immunogenicity of CT0596.Read full original descriptionShow less

A Phase I/II Clinical Trial to Evaluate the Safety, Efficacy, and Cellular Kinetics of CT0596 CAR-T Cell Injection in Patients With Relapsed/Refractory Multiple Myeloma

This is a Phase I/II, single-arm, open-label, multicenter clinical trial in patients with relapsed/refractory multiple myeloma (R/R MM). The study aims to evaluate the safety, tolerability, efficacy, cellular kinetics, and immunogenicity of CT0596.

Inclusion: Voluntarily participate in the trial; fully understand and sign the informed consent form (ICF); willing and able to comply with all trial procedures; Age ≥ 18 years, male or female; Patients with relapsed/refractory multiple myeloma (R/R 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; Relapsed/refractory disease defined per IMWG 2016 response criteria,; Must have measurable disease:; Life expectancy ≥ 12 weeks; Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; Must have Adequate organ function; 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。.

Exclusion: 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); Prior BCMA-targeted therapy (refer to the protocol for exceptions); 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; Received disease-directed therapy within 14 days or 5 half-lives (whichever is shorter) prior to lymphodepletion; Received any cell therapy within 6 months prior to ICF; or prior CAR-T with best response < PR; Received systemic corticosteroids equivalent to > 15 mg/day of prednisone within 7 days prior to lymphodepletion (excluding topical use); Received live-attenuated, inactivated, or RNA vaccines within 4 weeks prior to lymphodepletion; Major surgery within 2 weeks prior to lymphodepletion, or planned major surgery during trial or within 4 weeks after treatment (excluding local anesthesia surgeries); Severe cardiac diseases within 6 months prior to screening; Secondary primary malignancy requiring treatment or not in complete remission within 2 years prior to screening, except for successfully treated non-metastatic basal/squamous cell skin carcinoma, non-metastatic prostate cancer, carcinoma in situ (breast/cervix), non-muscle-invasive bladder cancer, or low-grade thyroid cancer; Positive for HIV, syphilis, active hepatitis B (HBV-DNA above LLoD), or active hepatitis C (positive for both HCV antibody and HCV-RNA); Presence of any uncontrolled active infection, including but not limited to active tuberculosis (per investigator), active CMV and/or EBV infection, etc; Allergy or intolerance to lymphodepletion agents, tocilizumab, or any component of infusion (e.g., DMSO); or history of severe allergy such as anaphylactic shock; Diagnosed with secondary plasma cell leukemia, solitary extramedullary plasmacytoma, Waldenström macroglobulinemia, POEMS syndrome, or primary light chain amyloidosis at screening; Severe pulmonary disease that may jeopardize the patient's life per investigator; Known symptomatic central nervous system (CNS) disease or suspected CNS metastasis; Pregnant or lactating women; Inability to tolerate an adequate lymphodepletion regimen; Patients assessed by the investigator as unable or unwilling to comply with protocol requirements, or otherwise unsuitable for participation.

ClinicalTrials.gov NCT07760454