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.
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,.
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).
Single group
CT0596
DrugCAR-T cells
Phase I:Adverse Events (AE) after CT0596 infusion
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria.
Phase I:Maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D)
Evaluate Dose limited toxicity and recommended dosage range after CT0596 infusion.
Phase II:Overall response rate (ORR)
Overall response rate (ORR) at Week 12 post-infusion, assessed by an Independent Review Committee (IRC) per IMWG 2016 criteria.
Overall response rate (ORR) as assessed by IRC and investigator
Overall response rate (ORR) defined as proportion of patients achieving partial response or better based on International Myeloma Working Group defined response criteria by IRC and investigator.
Complete response/stringent complete response (CR/sCR) rate
Rate of complete response/stringent complete response (CR/sCR) defined as proportion of patients achieving CR or better based on IMWG defined response criteria.
Rate of very good partial response (VGPR) and above
the proportion of patients achieving very good partial response, complete response or stringent complete response per IMWG response criteria.
Duration of response (DOR)
DOR is defined as the time from first achieving Partial Response (PR) or better to confirmed disease progression or death from any cause.
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