This study is a prospective, single-arm, multicenter trial designed to evaluate the hematologic response rate and safety of BCMA/CD3 bispecific antibody bridging therapy prior to CAR-T cell infusion in patients with relapsed/refractory multiple myeloma (RRMM).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
CM336 is a BCMA × CD3 bispecific antibody.
Overall Response Rate (ORR)
The proportion of subjects achieving stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) after treatment with CM336 injection
Time frame: Minimum 2 years after infusion
Safety and Tolerability
The incidence of treatment-emergent adverse events (TEAES)
Time frame: Minimum 2 years after infusion
Time to Response (TTR)
Time from first BCMA × CD3 bispecific antibody infusion to first hematologic response, Depth of best hematologic response: The highest-level response achieved at any timepoint.
Time frame: Minimum 2 years after infusion.
Duration of Response (DOR)
Duration of response (DOR) was defined as the time from first documented hematologic response (≥ partial response \[PR\]) to disease progression or death due to progression, whichever occurred first
Time frame: Minimum 2 years after infusion
Overall Survival (OS)
Time frame: Minimum 2 years after infusion
Progression-Free Survival (PFS)
Time frame: Minimum 2 years after infusion
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