Multicenter Clinical Study on the Safety and Effectiveness of CAR-T in the Treatment of Relapsed/Refractory Plasma Cell Tumors

Inclusion Criteria:

1. Fully understand and voluntarily sign the informed consent form, and be willing andable to comply with the visits, treatment plans, laboratory inspections, and otherrequirements of the research as specified in the test procedure;
2. Patients with relapsed/refractory plasma cell tumors determined by clinical diagnosis; The definition of relapsed/refractory plasma cell tumors is:
3. Primary resistance to standard treatment regimens;
4. Or PD occurs after standard treatment with at least second-line standardtreatment plan;
5. Or the last treatment effect is SD and the duration does not exceed 6 months;
6. Or treatment with proteasome inhibitors and immunomodulators is ineffective orrelapses;
7. Patients who have PD after autologous hematopoietic stem cell transplantation orconfirmed recurrence by biopsy within 12 months, or patients who undergo salvagetreatment after autologous hematopoietic stem cell transplantation have noremission or relapse after treatment.
8. According to RECIST version 1.1 , there should be at least one measurable tumor (softtissue mass) or serum M protein ≥10g/L or urine M protein ≥200mg/24h;
9. Subjects whose physical status scored by the Eastern Cooperative Oncology Group (ECOG)is 0~2;
10. 14 years old ≤ age ≤ 75 years old, both male and female;
11. Immunohistochemistry or flow cytometry detects tumor cells as BCMA or CD19/CD22/CD79positive;
12. The estimated survival period from the date of signing the informed consent form isgreater than 3 months;
13. Laboratory examinations meet the following conditions: hemoglobin ≥80g/L, plateletcount ≥50 × 109/L, absolute neutrophil count (ANC) ≥1.0 × 109/L, if the investigatorbelieves that the above inspection value is below the lower limit It is caused bytumor invading bone marrow and can be included in the group after consultation withthe sponsor;
14. The main organ function indicators meet the following conditions: AST (aspartateaminotransferase)/ALT (alanine aminotransferase)/ALP (alkaline phosphatase) ≤2.5 ULN,serum creatinine ≤1.5 ULN, total bilirubin ≤1.5 ULN, left Ventricular ejectionfraction (LVEF) ≥50%, and minimum pulmonary function reserve (dyspnea is not higherthan grade 1 and blood oxygen saturation> 92% under indoor conditions).

Exclusion Criteria:

1. Severe cardiac insufficiency, left ventricular ejection fraction <50%;
2. There is a history of severe lung dysfunction diseases;
3. The patient has had other malignant tumors in the past 5 years, except for skin basalcell carcinoma, breast carcinoma in situ and cervical carcinoma in situ that haveundergone radical treatment;
4. Combined with severe or persistent infection and cannot be effectively controlled;Severe infection: Refers to sepsis or uncontrolled infection of the infected foci, andcan be included in the group after infection is controlled
5. Combined metabolic diseases (except diabetes);
6. Combined with severe autoimmune disease or innate immune deficiency;
7. Untreated active hepatitis (hepatitis B, defined as hepatitis B virus surface antigen [HBsAg] test results are positive, HBV-DNA ≥ 500 IU/ml and abnormal liver function;hepatitis C, defined as hepatitis C antibody [ HCV-Ab] positive, HCV-RNA higher thanthe detection limit of the analysis method and abnormal liver function) or combinedwith hepatitis B and C co-infection;
8. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiencysyndrome (AIDS), or syphilis infection;
9. A history of severe allergies to biological products (including antibiotics);
10. Participate in any other clinical drug trials at the same time within one month;
11. There are other serious physical or mental illnesses or laboratory abnormalities thatmay increase the risk of participating in the research, or interfere with the resultsof the research, and patients who the researcher believes are not suitable forparticipating in this research.