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A Study of MBS314 in Participants With Relapsed/Refractory Multiple Myeloma.
Sponsor: Beijing Mabworks Biotech Co., Ltd.
Summary
This is a Phase I/Ⅱ, multicenter, open-label, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics(PD) and efficacy of a novel asymmetric trivalent tri-specific humanized antibody, MBS314, administered by intravenous (IV) infusion in participants with relapsed or refractory multiple myeloma. This entry-to-human study is divided in 2 parts: a dose escalation part (Phase Ⅰa) and an expansion part (Phase Ⅰb/Ⅱ).
Official title: A Phase Ⅰ/Ⅱ Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of MBS314 Injection in Patients With Relapsed/Refractory Multiple Myeloma.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
154
Start Date
2024-02-22
Completion Date
2028-03
Last Updated
2024-03-15
Healthy Volunteers
No
Conditions
Interventions
MBS314 Injection
Phase Ia: The patients confirming to the eligibility criteria will be assigned to 1 of the 7 dose groups (0.03/0.09/0.3/0.9 mg \~ 0.3/1.5/9.0/60 mg, respectively) based on the sequence of inclusion. Each patient will receive MBS314 as per the schedule specified in the respective arms. Phase Ib/Ⅱ: Based on the results of Phase Ⅰa, 1 or 2 recommended doses will be selected for Phase Ⅰb. Recommended Phase II Dose (RP2D) will be selected for Phase Ⅱ.
Locations (1)
Institute of Hematology and Blood Diseases Hospital
Beijing, China