To evaluate the safety and tolerability of chimeric antigen receptor gene-modified T cells targeting BCMA for the treatment of relapsed/refractory multiple myeloma
Age 18-80 years, no gender restrictions;
Diagnosed with refractory/relapsed multiple myeloma through physical examination, pathological examination, laboratory tests, and imaging studies;
Flow cytometry or histology confirms positive BCMA expression in myeloma cells;
As judged by the investigator, the expected survival time is >3 months;
Pregnant or nursing women, as well as women planning to become pregnant within the next six months;
Positive virology tests for hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus;
History of other tumors (except for those with skin or cervical in situ cancers that have been cured by radical treatment and show no evidence of disease activity);
Previously received treatment targeting BCMA;
Single group
CAR-T treatment
Biological/VaccinePeripheral blood lymphocyte collection, PBMC separation, BCMA CAR-T cell preparation/storage, lymphodepletion chemotherapy pretreatment for the subject, and BCMA CAR-T cell infusion.
Complete remission rate (CR)
Negative serum and urine immunofixation electrophoresis, disappearance of soft tissue plasmacytoma, and less than 5% plasma cells in the bone marrow. For patients who rely solely on serum FLC levels as a measurable lesion, in addition to meeting the above CR criteria, it is also required that the ratio of serum FLC is restored to normal in two consecutive evaluations.
Adverse events (AE)
Any adverse and unexpected signs, symptoms, or diseases.
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