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NOT YET RECRUITING
NCT07911748
PHASE1/PHASE2

A Study of MBS314 for Injectionin Participants With Relapsed/Refractory Multiple Myeloma.

Sponsor: Beijing Mabworks Biotech Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a Phase I/II, multicenter, open-label, dose-escalation and dose-expansion study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of MBS314, a novel asymmetric trivalent trispecific humanized antibody targeting GPRC5D, BCMA and CD3, administered by subcutaneous (SC) injection in participants with relapsed or refractory multiple myeloma. The investigational drug is MBS314 for Injection (high-concentration lyophilized formulation, 90 mg/vial, reconstituted to 90 mg/mL); this study is the first-in-human (FIH) study of this formulation. The study is divided into 2 parts: a dose escalation part (Phase I) and a dose expansion part (Phase II). In Phase I, eligible participants will be sequentially assigned to 1 of the 3 planned dose cohorts and receive MBS314 by SC injection using a step-up dosing (SUD) strategy, and dose escalation follows the Bayesian Optimal Interval (BOIN) design with a target toxicity rate of 33%. In Phase II, 1 to 3 dose groups will be selected based on Phase I results to further evaluate the efficacy of MBS314 at the recommended dose(s).

Official title: A Phase Ⅰ/Ⅱ Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of MBS314 for Injection in Patients With Relapsed/Refractory Multiple Myeloma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

78

Start Date

2026-11

Completion Date

2028-11

Last Updated

2026-11-03

Healthy Volunteers

No

Interventions

DRUG

MBS314 for Injection

Phase I: Eligible participants will be sequentially assigned to one of three dose groups under BOIN design (Dose Group 1: 3-step SUD \[0.5/3.0/15.0 mg\], target dose 90.0 mg; Dose Group 2 \[tentative\]: 3-step SUD \[1.5/9.0/45.0 mg\], target dose 135.0 mg; Dose Group 3 \[tentative\]: 3-step SUD \[2.5/15.0/90.0 mg\], target dose 180.0 mg). MBS314 is given subcutaneously (single injection volume ≤2.0 mL; injection sites ≥2 cm apart). Step-up dosing is used in Cycle 1: priming doses on C1D1, C1D4, C1D7 and target dose on C1D10. From Cycle 2 onwards, target dose is administered Q4W. Phase II: Based on Phase I findings, 1-3 dose groups will be selected for dose expansion (10-20 participants per group, total 10-60).