Chimeric Antigen Receptor Modified T Cells Targeting BCMA for the Treatment of Relapsed/Refractory Multiple Myeloma

A Clinical Study of the Safety and Efficacy of Chimeric Antigen Receptor-modified T Cells Targeting BCMA for the Treatment of Relapsed/Refractory Multiple Myeloma

To evaluate the safety and tolerability of chimeric antigen receptor gene-modified T cells targeting BCMA for the treatment of relapsed/refractory multiple myeloma

Subjects who meet the eligibility criteria, PBMC will be collected by blood cell separator and 50 mL of plasma will be collected for preparation of CAR-T and frozen storage of CAR-T preparations; patients will be treated with autologous BCMA CAR-T transfusion and followed up for a period of 3 years, with specific efficacy judgments referring to the IMWG Clinical Efficacy Evaluation Criteria.

Inclusion Criteria:

1. Age 18-80 years, no gender restrictions;
2. Diagnosed with refractory/relapsed multiple myeloma through physical examination, pathological examination, laboratory tests, and imaging studies;
3. Flow cytometry or histology confirms positive BCMA expression in myeloma cells;
4. As judged by the investigator, the expected survival time is >3 months;
5. ECOG performance status score ≤2, KPS >60%;
6. The patient has good liver, kidney, heart, and lung function: ALT and AST ≤2.5×ULN, those with liver involvement can be relaxed to ≤5×ULN; serum total bilirubin <34 μmol/L; creatinine clearance rate >30 mL/min; heart ejection fraction (EF) ≥40%, no pericardial effusion and significant arrhythmia; indoor SpO2 ≥92%;
7. Peripheral blood lymphocyte absolute count ALC ≥0.5 ×10^9/L, PLT >30×10^9/L, Hb >80 g/L and has a single collection venous access, and there are no other contraindications for hematopoietic cell separation;
8. Those with fertility must agree to use highly effective contraceptive methods;
9. The subject or their legal guardian can understand and is willing to sign a written informed consent form voluntarily.

Exclusion Criteria:

1. Pregnant or nursing women, as well as women planning to become pregnant within the next six months;
2. Positive virology tests for hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus;
3. 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);
4. Previously received treatment targeting BCMA;
5. Underwent autologous hematopoietic stem cell transplantation within the last 6 weeks;
6. Presence of uncontrolled active bacterial or fungal infection;
7. Allergic to research-related drugs or cell components;
8. Presence of active autoimmune diseases;
9. Currently have unstable or active ulcers or gastrointestinal bleeding;
10. Unable to cooperate with treatment and efficacy evaluation due to mental or psychological disorders;
11. Received other experimental drug treatments within the last 3 months;
12. The researcher believes that for other reasons, the individual is not suitable for the clinical trial.