Universal CAR-T Cell Therapy for MM

NCT07248176 | Recruiting

• 1 other identifier: 2025-BRL-305-01-IIT
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Myeloma; Multiple Myeloma in Relapse; Multiple Myeloma, Refractory

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Treatment group

EXPERIMENTAL

5.0-10×10\^6cells/kg

Drug: Targeted BCMA Gene-Modified Allogeneic Chimeric Antigen Receptor T-Cell Injection

Interventions

Targeted BCMA Gene-Modified Allogeneic Chimeric Antigen Receptor T-Cell Injection DRUG

The study drug is administered intravenously at a fixed dose within 1-2 days after lymphocyte depletion, and its efficacy and safety are observed.

Also known as: BRL-305

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bioray Laboratories: lead
• Shanghai Tongji Hospital (Tongji Hospital of Tongji University): collaborator

Study Sites (1)

Shanghi Tongji Hospital (Tongji Hospital of Tongji University)

Shanghai, 620000, China

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

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

Study Officials

• Ping Li, PhD

  13564181131

  STUDY DIRECTOR

Central Study Contacts

Ping Li, phD

CONTACT

13564181131; lilyforever76@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: April 10, 2025
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): April 18, 2028
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)