RecruitingPhase 1Phase 2NCT06232096

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

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

Sponsor

Beijing Mabworks Biotech Co., Ltd.

Enrollment

154 participants

Start Date

Feb 22, 2024

Study Type

INTERVENTIONAL

Conditions

Relapsed or Refractory Multiple Myeloma

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new drug called MBS314 for people with multiple myeloma (a blood cancer) that has come back or stopped responding to previous treatments. **You may be eligible if...** - You are 18 years old or older - You have been diagnosed with multiple myeloma that has relapsed (come back) or is refractory (not responding to treatment) - Your cancer shows measurable signs in blood or urine tests - You are in good general health (able to carry out normal activities) - Your blood counts, liver, and kidneys are functioning adequately **You may NOT be eligible if...** - Your myeloma has spread to the brain or spinal fluid - You have an active infection - You have HIV or active hepatitis B or C - You have received recent cancer treatment, live vaccines, or major surgery within 28 days - You have a history of serious autoimmune conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMBS314 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

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NCT06232096

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