Universal CAR-T Cell Therapy for MM

NCT ID: NCT07248176

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-10
• Study Completion Date: 2028-04-18

Brief Summary

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

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 .

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

5.0-10×10\^6cells/kg

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

BRL-305

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Tongji Hospital (Tongji Hospital of Tongji University)

UNKNOWN

Sponsor Role: collaborator

Bioray Laboratories

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ping Li, PhD

Role: STUDY_DIRECTOR

13564181131

Locations

Shanghi Tongji Hospital (Tongji Hospital of Tongji University)

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Ping Li, phD

Role: CONTACT

lilyforever76@126.com

13564181131

Facility Contacts

Ping Li, phD

Role: primary

13564181131

Other Identifiers

2025-BRL-305-01-IIT

Identifier Type: -

Identifier Source: org_study_id