CELL INTELLIGENCE · 肿瘤细胞治疗研究

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.

主要终点：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. · Up to 36 months
次要终点：Adverse events (AE)

• CAR-T · EXPERIMENTAL

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