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.
Phase I employs a BOIN design for dose escalation to determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D). Phase II will further confirm the clinical efficacy of CT0596 at the RP2D in R/R MM, with the primary efficacy endpoint being the overall response rate (ORR) at Week 12 post-infusion, assessed by an Independent Review Committee (IRC) per International Myeloma Working Group(IMWG) 2016 criteria.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
68
CAR-T cells
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
NOT_YET_RECRUITINGRenji Hospital,Shanghai Jiao Tong University School Of Medicine
Shanghai, China
RECRUITINGPhase I:Adverse Events (AE) after CT0596 infusion
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria.
Time frame: 24months after CT0596 infusion
Phase I:Maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D)
Evaluate Dose limited toxicity and recommended dosage range after CT0596 infusion.
Time frame: 28 days 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.
Time frame: Week 12 after CT0596 infusion
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.
Time frame: 24 months after CT0596 infusion
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.
Time frame: 24 months after CT0596 infusion
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.
Time frame: 24 months after CT0596 infusion
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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.
Time frame: 24 months after CT0596 infusion
Minimal residual disease (MRD) negative rate
MRD negative rate is defined as the proportion of patients achieve a MRD negative by NGF(Next Generation Flow) at a sensitivity of 10-5.
Time frame: 24 months after CT0596 infusion
Time to response (TTR)
TTR defined as the time from the date of infusion to the date of initial assessment of PR or better according to IMWG2016 criteria.
Time frame: 24 months after CT0596 infusion
Progression-free survival (PFS)
PFS defined as the time from the date of infusion of the subject to the first assessment of confirmed disease progression or death from any cause according to IMWG2016 criteria, whichever occurs first.
Time frame: 24 months after CT0596 infusion
Overall survival (OS)
OS defined as the time from the date of infusion of the subject to death from any cause.
Time frame: after CT0596 infusion
Pharmacokinetic parameters of CT0596, including CAR copy number, peak value, AUC (area under the curve), in vivo persistence, etc
Time to peak expansion, peak expansion, area under the curve (AUC) and duration in plasma after infusion of CT0596 cells.
Time frame: 24 months after CT0596 infusion
Cytokines in the peripheral blood
Serum concentrations of interleukin (IL)-6 after CT0596 infusion.
Time frame: up to 24 months after CT0596 infusion
Immunogenicity (anti-drug antibodies)
Serum concentrations of anti-drug antibodies after CT0596 infusion
Time frame: up to 24 months after CT0596 infusion