This study is a multicenter, open-label, dose-escalation/dose-expansion clinical Phase I trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy profile of SHR-9539 Injection in patients with multiple myeloma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
138
SHR-9539 for dose escalation/dose extension
West China Hospital of Sichuan University
Chengdu, Sichuan, China
RECRUITINGRP2D of SHR-9539 injection
Determination of the recommended phase 2 dose (RP2D) of SHR-9539 injection in patient with multiple myeloma.
Time frame: Approximately 24 months
Incidence and severity of AE
Assessing the incidence of adverse events (AEs) mainly using the Common Terminology Criteria for Adverse Events (CTCAE Version 5), and CRS and ICANS were graded according to ASTCT standards.
Time frame: Up to follow-up period, approximately 24 months
Cmax
Maximum serum concentration
Time frame: Up to follow-up period, approximately 24 months
Tmax
Time to reach maximum plasma concentration.
Time frame: Up to follow-up period, approximately 24 months
Overall Response Rate (ORR)
ORR assessed by the IMWG response criteria.
Time frame: Up to follow-up period, approximately 24 months
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