NCT07537049

BR101 in Patients With Relapsed/Refractory Multiple Myeloma

An Open-Label, Single-Arm Clinical Study Evaluating the Safety and Efficacy of BR101 Injection in Patients With Relapsed/Refractory Multiple Myeloma

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is an open-label, single-arm, dose-escalation and dose-expansion clinical trial designed to evaluate the maximum tolerated dose, safety, pharmacokinetic profile following administration of BR101 injection, and preliminary efficacy in subjects with relapsed or refractory multiple myeloma.

Detailed description

This study is a single-center, open-label, single-arm, phase 1 clinical trial consisting of a dose-escalation phase followed by a dose-expansion phase.The primary objectives are to determine the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), and to characterize the safety and tolerability profile of BR101 injection in subjects with relapsed or refractory multiple myeloma.Secondary objectives include evaluating the pharmacokinetic (PK) characteristics of BR101 after intravenous administration and exploring the preliminary anti-tumor efficacy of the investigational product in this patient population.Throughout the study, adverse events, vital signs, laboratory parameters, and disease status will be closely monitored to comprehensively assess the safety, pharmacokinetics, and preliminary clinical activity of BR101.

Conditions

• Multiple Myeloma (MM)

Interventions

Type	Name	Description
BIOLOGICAL	BR101 injection	Single doses and Multiple doses of BR101 injection will be infused.

Timeline

• Start date: 2026-04-30
• Primary completion: 2027-04-30
• Completion: 2029-04-30
• First posted: 2026-04-17
• Last updated: 2026-04-17

Locations

1 site across 1 country: China