To Evaluate Safety and Efficacy of S103 for Treating Relapsed or Refractory Multiple Myeloma
This study is a Phase I/II, single-arm, open-label, single-infusion clinical trial designed to evaluate the clinical efficacy and safety of S103 in patients with Relapsed or Refractory Multiple Myeloma
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Administration method: intravenous infusion;Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.
Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) after S103 infusion
Safety
Time frame: 28 days
Incidence, severity, and relationship of DLTs, AEs and SAEs.
Safety. To evaluate the possible adverse events occurred within 2 years after S103 infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity
Time frame: 2 years
Pharmacokinetic data parameters.Analysis using CAR DNA copy number measured by qPCR; the highest concentration of S103 cells expanded in peripheral blood after administration
PK.To characterize the in vivo expansion kinetics of S103.
Time frame: 2 years
Pharmacodynamics data parameters. Proportion of BCMA-positive cells and Cytokine release.
PD.To assess the ability of S103 to eliminate BCMA-positive B cells.
Time frame: 2 years
Objective response rate after S103 infusion
Efficacy
Time frame: 3 months
Best overall response after S103 infusion
Effectiveness. Best overall response means the proportion of patients with the best efficacy after S103 cell therapy.
Time frame: 2 years
Duration of Response after S103 infusion
Effectiveness. The time from the first documented objective response to the first documented disease progression or death from any cause, whichever occurs first
Time frame: 2 years
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Progression-Free Survival after S103 infusion
Effectiveness. The time from the initiation of S103 infusion to the first documented disease progression or death from any cause, whichever occurs first.
Time frame: 2 years
Overall survival after S103 infusion
Effectiveness. Overall survival means the time from infusion of S103 cells to death of subjects from any cause.
Time frame: 2 years
Time to Response after S103 infusion
Effectiveness. The time from the initiation of S103 infusion to the first documented objective response.
Time frame: 2 years
MRD-negative ORR at Month 3 post-infusion by flow cytometry
Effectiveness
Time frame: 3 months
MRD-negative ORR at Day-28 post-infusion by flow cytometry.
Effectiveness
Time frame: 28 days