Human BCMA Targeted T Cells Injection Therapy for BCMA-positive Relapsed/Refractory Multiple Myeloma

Inclusion Criteria:

1. Subjects volunteer to participate in clinical research, understand and know theresearch and sign informed consent document, willing to complete all the trialprocedures;
2. 18 to 70 Years Old, Male and female;
3. Expected survival > 12 weeks;
4. Previously diagnosed as multiple myeloma by IMWG updated criteria (2014);
5. Patients with positive pathological test results or flow cytometry proving that BCMAexpression of malignant plasma cells in bone marrow or plasma cell tumors ≥30%;
6. One of the following indicators is satisfied:
7. Serum M protein IgG ≥ 10 g/L, or IgA > 10 mg/L, or IgD > 5 mg/L;
8. Urine M protein ≥ 200 mg/24h;
9. Serum free light chain ≥ 100 mg/L;
10. Patients with relapsed/refractory multiple myeloma. Relapsed is defined as: Patients have disease progression after at least three-line treatment regimens.Patients previously received at least 3 different mechanisms treatment regimens formultiple myeloma, including protease inhibitors and immunomodulators, and have diseaseprogression within 60 days of the latest treatment ; Refractory is defined as:Patients who achieved remission in the piror therapies, have disease progressionwithin 60 days, or after the latest therapy.
11. Those who relapse 90 days after stem cell transplantation
12. ECOG score 0-1;
13. Liver, kidney and cardiopulmonary functions meet the following requirements:
14. Creatinine clearance (estimated by Cockcroft Gault formula) ≥ 40 mL/min;
15. Left ventricular ejection fraction >50%;
16. Baseline peripheral oxygen saturation >95%;
17. Total bilirubin ≤ 2×ULN; ALT and AST ≤2.5 × ULN;
18. The venous access required for collection can be established, and no leukocytecollection contraindications.

Exclusion Criteria:

1. Accompanied by other uncontrolled malignancies;
2. Subjects with positive HBsAg or HBcAb and peripheral blood HBV DNA titer is higherthan the lower limit of detection of the research institution; HCV antibody positiveand peripheral blood HCV RNA positive; HIV antibody positive; syphilis primaryscreening antibody positive;
3. Any instability of systemic disease, including but not limited to unstable angina,cerebrovascular accident, or transient cerebral ischemic (within 6 months prior toscreening), myocardial infarction (within 6 months prior to screening), congestiveheart failure (New York heart association (NYHA) classification ≥ III), severearrhythmia, liver, kidney or metabolic disease with poor drug control;
4. Patients who are accounted to be not appropriate for this trail by investigator;
5. Pregnant or lactating, or planning to have a pregnancy during or within 1 year aftertreatment;
6. Received CAR-T treatment or other gene therapies before enrollment;
7. Those who failed to sign informed consent form or comply with the research procedures;Unwilling or unable to comply with research requirements;
8. Have had severe immediate hypersensitivity reactions to any drugs used in thisresearch;
9. The presence or suspicion of fungi, bacteria, viruses or other infections that areuncontrollable or requiring intravenous treatment;
10. In the past two years, the terminal organ was damaged due to autoimmune diseases (suchas crohn's disease, rheumatoid arthritis, systemic lupus erythematosus), or thesystemic use of immunosuppressive or other systemic disease control drugs wasrequired;
11. Have a history of central nervous system (CNS) disease, such as epilepsy, seizures,paralysis, aphasia, stroke, severe brain damage, dementia, Parkinson's disease,psychosis.