CAR-T Injection in Transplant In-Eligible Newly Diagnosed Multiple Myeloma Patients
This is a single-arm, single-center, open-label clinical study to evaluate the safety and efficacy of CAR-T in patients with NDMM.
• 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.
• Or 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 0-3 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 ≥ 15mL/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.