This is a Phase I, single-center, single-arm, open-label clinical study to evaluate the safety, tolerability, and preliminary efficacy of SL4903 autologous T-cell injection (CAR-T cell therapy) in adult patients with relapsed or refractory multiple myeloma (r/r MM) who have failed prior standard therapies. The study employs a "3+3" dose-escalation design with three planned dose levels (1×10⁶, 2×10⁶, and 3×10⁶ CAR+ cells/kg). Approximately 9 to 18 evaluable subjects will be enrolled to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D), and to characterize the safety profile and potential anti-myeloma activity of SL4903.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Eligible subjects, identified through application of inclusion/exclusion criteria, will be evaluated for tumor type, tumor burden, vital-sign status, and other comprehensive factors before receiving SL4903(1×10⁶ CAR⁺ cells/kg) cellular therapy.
Eligible subjects, identified through application of inclusion/exclusion criteria, will be evaluated for tumor type, tumor burden, vital-sign status, and other comprehensive factors before receiving SL4903(2×10⁶ CAR⁺ cells/kg) cellular therapy.
Eligible subjects, identified through application of inclusion/exclusion criteria, will be evaluated for tumor type, tumor burden, vital-sign status, and other comprehensive factors before receiving SL4903(3×10⁶ CAR⁺ cells/kg) cellular therapy.
Number and incidence rate of adverse events following intravenous infusion of SL4903 cells
Within one month after cell infusion, all documented adverse events-including cytokine-release syndrome and neurotoxicity-will be analyzed for incidence, frequency, and severity to evaluate the safety of SL4903 and to determine the maximum tolerated dose (MTD).
Time frame: one month
Overall response rate (ORR)
Percentage of subjects who achieved partial response (PR) or better according to IMWG Uniform Response Criteria for Multiple Myeloma
Time frame: at 3, 6, 9, 12, 18, and 24-month after CAR-T infusion
Complete response rate (CRR)
Percentage of subjects who achieved complete response (CR) or stringent complete response (sCR) according to IMWG Uniform Response Criteria for Multiple Myeloma
Time frame: at 3, 6, 9, 12, 18, and 24-month after CAR-T infusion
Time to Response (TTR)
Time from SL4903 CAR-T infusion to first documentation of response evaluated by investigators
Time frame: Minimum of 2 years post SL4903 CAR-T infusion
Progression-free Survival (PFS)
Time from SL4903 CAR-T infusion to first documentation of progressive disease (PD), or death due to any cause, whichever occurs first
Time frame: Minimum of 2 years post SL4903 CAR-T infusion
Duration of Response (DOR)
Time from first response evaluated by investigators to disease progression or death from any cause
Time frame: Minimum of 2 years post SL4903 CAR-T infusion
Overall Survival (OS)
Time from SL4903 CAR-T infusion to time of death due to any cause
Time frame: Minimum of 2 years post SL4903 CAR-T infusion
Minimal Residual Disease (MRD) negative rate
Proportion of subjects who achieved MRD negative
Time frame: at 3, 6, 9, 12, 18, and 24-month after CAR-T infusion
Pharmacokinetic (Cmax)
Testing CARgene copies and CAR-T/T% in peripheral blood by qPCR and Flow cytometry,then analysising the Cmax.
Time frame: at day0 to day28 after CAR-T infusion
Pharmacokinetic (Tmax)
Testing CARgene copies and CAR-T/T% in peripheral blood by qPCR and Flow cytometry,then analysising the time to peak (Tmax).
Time frame: at day0 to day28 after CAR-T infusion
Pharmacokinetic (AUCday0~28)
Testing CARgene copies and CAR-T/T% in peripheral blood by qPCR and Flow cytometry,then analysising the AUC(day0\~28).
Time frame: at day0 to day28 after CAR-T infusion
proportion of peripheral plasma cells
The proportion of peripheral plasma cells at various time points
Time frame: at day0 , day7, day10, day14 and day28 after CAR-T infusion
cytokines level
The release amount of cytokines at various time points
Time frame: at day0 , day7, day10, day14 and day28 after CAR-T infusion
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.