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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07248176

Enrollment

Registered

2025-11-25

Start date

2025-04-10

Completion date

2028-04-18

Last updated

2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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 .

Interventions

DRUGTargeted 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

Countries

China

Contacts

Primary ContactPing Li, phD

lilyforever76@126.com13564181131

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026