Universal CAR-T Cell Therapy for MM

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: Multiple Myeloma; Multiple Myeloma in Relapse; Multiple Myeloma, Refractory
• Intervention / Treatment: Drug: Targeted BCMA Gene-Modified Allogeneic Chimeric Antigen Receptor T-Cell Injection

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

• Study Contact: Name: Ping Li, phD; Phone Number: 13564181131; Email: lilyforever76@126.com

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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

Collaborators and Investigators

• Sponsor: Bioray Laboratories
• Collaborators: Shanghai Tongji Hospital (Tongji Hospital of Tongji University)
• Investigators: Study Director: Ping Li, PhD, 13564181131

Study record dates

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: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma
• 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