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