Universal CAR-T Cell Therapy for MM

November 28, 2025 updated by: Bioray Laboratories

A Clinical Study on the Safety and Efficacy of Allogeneic CAR T Cells Targeting BCMA in the Treatment of Adult r/r Multiple Myeloma

This trial aims to evaluate the safety and efficacy of BCMA-UCART in treating patients with r/r multiple myeloma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a non-randomized, open-label, single-arm clinical trial designed to assess the efficacy and safety of combination therapy for r/r multiple myeloma using universal CAR-T cells targeting BCMA .

Study Type

Interventional

Enrollment (Estimated)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China, 620000
        • Recruiting
        • Shanghi Tongji Hospital (Tongji Hospital of Tongji University)
        • Contact:
          • Ping Li, phD
          • Phone Number: 13564181131

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Expected survival of at least 3 months;
  2. Subjects should have measurable disease that meets the IMWG 2016 criteria;
  3. Previously received at least two lines of prior anti-myeloma therapy ；
  4. Relapse , failure to achieve at least a minimal response, or disease progression after the last treatment ；
  5. BCMA positive；
  6. ECOG score 0-1；
  7. No severe impairment or suppression of liver, kidney, coagulation, bone marrow, or lung function.

Exclusion Criteria:

  1. Pregnant or breastfeeding women;
  2. History of other malignant tumors;
  3. Active autoimmune diseases requiring immunotherapy;
  4. Previously received allogeneic stem cell transplantation;
  5. Previous use of CAR-T cells or other genetically modified T cell therapies;
  6. Previously received targeted BCMA therapy;
  7. Severe cardiovascular disease;
  8. Active infection;
  9. Positive virology test;
  10. Clinically significant central nervous system (CNS) diseases or pathological changes.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group
5.0-10×10^6cells/kg
Drug: Targeted BCMA Gene-Modified Allogeneic Chimeric Antigen Receptor T-Cell Injection
The study drug is administered intravenously at a fixed dose within 1-2 days after lymphocyte depletion, and its efficacy and safety are observed.
Other Names:
  • BRL-305

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DLT
Time Frame: Within 28 Days After BRL-305 Infusion
The number and severity of dose-limiting toxicity (DLT) events
Within 28 Days After BRL-305 Infusion
AEs
Time Frame: Up to 24 Months After BRL-305 Infusion
The total number, incidence, and severity of AEs
Up to 24 Months After BRL-305 Infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bioray Laboratories

Collaborators

Shanghai Tongji Hospital (Tongji Hospital of Tongji University)

Investigators

  • Study Director: Ping Li, PhD, 13564181131

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2025

Primary Completion (Estimated)

March 15, 2027

Study Completion (Estimated)

April 18, 2028

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Estimated)

November 25, 2025

Study Record Updates

Last Update Posted (Actual)

December 1, 2025

Last Update Submitted That Met QC Criteria

November 28, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-BRL-305-01-IIT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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