Universal CAR-T Cell Therapy for MM

Bioray Laboratories

Status: Enrolling

Conditions: Multiple Myeloma in Relapse; Multiple Myeloma; Multiple Myeloma, Refractory

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

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07248176

2025-BRL-305-01-IIT

Details and patient eligibility

About

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

Full 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 .

Enrollment: 6 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Treatment group

Experimental group

Description:

5.0-10×10\^6cells/kg

Treatment:

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