Universal CAR-T Cell Therapy for MM
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Targeted BCMA Gene-Modified Allogeneic Chimeric Antigen Receptor T-Cell Injection.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma, Multiple Myeloma in Relapse, Multiple Myeloma, Refractory. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Clinical Study on the Safety and Efficacy of Allogeneic CAR T Cells Targeting BCMA in the Treatment of Adult r/r Multiple Myeloma
Overview
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
- 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.
Primary outcome measures
- DLT [Time frame: Within 28 Days After BRL-305 Infusion]
- AEs [Time frame: Up to 24 Months After BRL-305 Infusion]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghi Tongji Hospital (Tongji Hospital of Tongji University) — Shanghai
Identifiers
NCT: NCT07248176 · 2025-BRL-305-01-IIT