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

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of MBS314, a new asymmetric trivalent tri-specific humanized antibody, in people with relapsed or refractory multiple myeloma. This Phase I/II, multicenter, open-label study is the first time this drug is being tested in humans and is sponsored by Beijing Mabworks Biotech Co., Ltd. The study is divided into two parts: a dose escalation phase (Phase Ia) and an expansion phase (Phase Ib/II). During Phase Ia, participants will receive MBS314 in one of seven different dose groups ranging from 0.03 mg to 60 mg, given by intravenous infusion according to the assigned schedule. Based on the results from this phase, one or two doses will be chosen for the Phase Ib/II part, where the recommended Phase II dose (RP2D) will be selected. The treatment involves receiving the study drug through IV infusions at specified doses and schedules. Participants will undergo assessments including monitoring for adverse events, dose-limiting toxicities, and determination of maximum tolerated dose. Efficacy will be evaluated by overall response rates and other measures such as complete response rates and minimal residual disease negativity over up to four years. Safety and tolerability will be followed for up to 29 months, with ongoing evaluations during the study. Participant involvement includes regular clinical visits for drug administration and detailed monitoring of health status and treatment effects throughout the study period.

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