AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

A Clinical Study of CT0596 CAR-T in Relapsed/Refractory Multiple Myeloma

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllUCARsgen Biotech Limited
💬

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * Pregnant or lactating women. * 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. * 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). * 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 cardiac diseases within 6 months prior to screening. * Severe pulmonary disease that may jeopardize the patient's life per investigator. * Inability to tolerate an adequate lymphodepletion regimen. * 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. * Known symptomatic central nervous system (CNS) disease or suspected CNS metastasis. * Patients assessed by the investigator as unable or unwilling to comply with protocol requirements, or otherwise unsuitable for participation.
💊

What it tests

  • CT0596
📍

Where

2 sites
The First Affiliated Hospital of Soochow University
Suzhou, China
Renji Hospital,Shanghai Jiao Tong University School Of Medicine
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy