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Brief Title: A Study of MBS314 in Participants With Relapsed/Refractory Multiple Myeloma.
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.
Study ID: NCT06232096
Brief 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).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Institute of Hematology and Blood Diseases Hospital, Beijing, , China
Name: Lugui Qiu, Doctor
Affiliation: Institute of Hematology & Blood Diseases Hospital, China
Role: PRINCIPAL_INVESTIGATOR