Study of FasT CAR-T GC012F Injection NDMM Patients

Inclusion Criteria: Age ≥18 when signing informed consent form（ICF） Documented evidence of multiple myeloma at diagnosis as defined by IMWG guidelines ,monoclonal plasma cells in the bone marrow ≥10% and/or serum M protein ≥ 3 g/dL and/or 24h urine light chain ≥ 500 mg and/or presence of a biopsy proven plasmacytomas, not meet evidence of Smoldering Myeloma with SLiM/CRAB syptoms, and meet at least 2 of a-c or meet d of the following criteria at screening: Serum M protein ≥ 2 g/dL; Serum involved / uninvolved free light chain ratio ≥ 20; Bone marrow involved with monoclonal plasma cells ≥20% ; With Cytogenetic high-risk markers. Documented evidence of multiple myeloma at diagnosis as defined by IMWG guidelines CRAB (calcium elevation, renal insufficiency, anemia, and bone abnormalities)/SLiM criteria, monoclonal plasma cells in the bone marrow ≥10% or presence of a biopsy proven plasmacytomas, and measurable secretory disease according to IMWG criteria meet one or more of the following criteria at screening: Serum M protein ≥ 1 g/dL; Urine M protein ≥ 200 mg/24h; Serum free light chain sFLC ≥ 10 mg/dL with abnormal serum immunoglobulin κ/λ free light chain ratio. ECOG score was 0-2 at screen; Estimated life expectancy ≥3 months; Absolute neutrophil count (ANC) ≥ 1.5×10^9/L without use of growth factors; Platelet count ≥ 50×10^9/L without transfusion support within 7 days before the screen; Hemoglobin≥ 60 g/L; Adequate functional reserve of organs: ALT/AST ≤ 2.5× ULN(Upper Limit of Normal); Creatinine clearance ≥ 20mL/min; Serum total bilirubin ≤ 1.5×ULN, except in subjects with congenital bilirubinemia,then direct bilirubin ≤ 1.5×ULN; The left ventricular ejection fraction (LVEF)≥50%, and no clinically significant ECG abnormalities were found; Basic oxygen saturation in natural indoor air: SPO2>92%. Adequate venous access for apheresis collection, and no other contraindications to apheresis; Subjects and sexual partner with fertility are willing to use effective and reliable method of contraception for at least 1 year after CAR-T cell infusion, serum HCG should be negative in females with fertility both at screening and baseline; Subjects must sign a written informed consent. Exclusion Criteria: Patients who are transplant eligible high-risk patients and plan to adopt auto/allo-transplantation Subject has had radiation therapy within 14 days of screening; Subjects has plasma cell leukemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes); Subjects has a diagnosis of primary amyloidosis, Waldenstroem's disease, monoclonal gammopathy of undetermined significance, or smoldering multiple myeloma; Having other tumors (excluding non-melanoma skin cancer and cervical cancer in situ bladder cancer and breast cancer that have been disease-free for more than 5 years); Evidence of serious mental disorders or changes in mental status, or the presence of central nervous system or diseases, such as seizures, cerebrovascular ischemia/hemorrhage, dementia, cerebellar diseases, or autoimmune diseases involving CNS; History of hereditary diseases such as Fanconi anemia, Schrader syndrome, Costerman syndrome, or any other known bone marrow failure syndrome; Clinically significant cardiac disease including: uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities, grade III-IV heart failure or myocardial infarction cardiac angioplasty or stenting unstable angina or other clinically significant cardiac conditions within one year prior to enrollment; Presence of any indwelling catheter or drainage tube (e.g., percutaneous nephrostomy catheter indwelling catheter bile drainage tube or pleural/peritoneal/pericardial catheter) The use of a dedicated central venous catheter is permitted; Confirmed or suspected CNS involved; A positive virological result for any of the following: HIV, HCV, HBsAg（If HBcAg positive, DNA copies must below the LOQ）, TPPA; Other severe viral or bacterial infections or uncontrolled systemic fungal infections are present; Severe allergic history or allergic constitution; There is a history of an autoimmune disease (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) that has resulted in terminal organ damage or requires systemic immunosuppressive/disease modulating drugs in the past 2 years; Presence of lung disease (such as pulmonary fibrosis); Subjects has had major surgery within 2 weeks before screen or has not fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study; Poor compliance due to physiological, family, social, and geographical factors, etc., and inability to comply with the research program and follow-up plan; Pregnant or lactating women; Investigator assessment deemed to be ineligible.