Clinical Study of CAR-BCMA T in Patients With Refractory or Relapsed Multiple Myeloma

Inclusion Criteria

• •Patients aged between 18 \~ 70 with relapsed or refractory multiple myeloma.
• •Bone marrow sample is confirmed as BCMA-positive by flow cytometry or pathological examination.
• •Patients with relapsed or refractory multiple myeloma who meet the following conditions:
• •1. Curative efficacy is little or disease progressed after 2 courses of standard treatment regimen;
• •2. Disease relapsed after chemotherapy or HSCT. Curative efficacy is little or disease progressed after 2 courses of original treatment regimen;
• •3. More than 60 days between last treatment and disease progression;
• •4. Autologous or allogeneic SCT is not available at present, or patient refuses to receive SCT;
• •5. No response to treatment is defined according to International Myeloma Working Group 2014 version as not achieving CR (including CR, sCR, ICR, MCR) or PR (including VGPR, PR, MR) after 2 consecutive cycles of treatment with current therapy, and the interval between the 2 cycles is no more than 60 days. Disease progression is defined as per 《Chinese Guidelines for Diagnosis and Treatment of Multiple Myeloma》 (Revision in 2015). At least one of the following conditions should be met:Serum M-protein increases ≥ 25% (absolute increase should be ≥ 5 g/L); If serum M protein is ≥ 50 g/L at baseline, increase of serum M protein can be ≥ 10 g/L; Urine M-protein increases ≥ 25% (absolute increase should be ≥ 200 mg/24 h); If the serum and urine M-protein are not detectable, a ≥ 25% increase in the difference between involved and uninvolved FLC levels is required (absolute increase should be ≥ 100 mg/L); Bone marrow plasma cell percentage increases ≥ 25% (absolute increase should be ≥ 10%); Size of existing bone lesions or soft tissue plasmacytomas increases by ≥ 25%, or development of new lytic bone lesions or soft tissue plasmacytomas; Development of hypercalcemia that can be attributed to plasma cell proliferative disorder (corrected calcium is \> 2.8 mmol/L or 11.5 mg/dL); Disease progression must be confirmed by 2 sequential assessments.
• •Expected survival \> 12 weeks.
• •Disease is measurable, and at least one of the following conditions should be satisfied:
• •Serum M-protein is ≥ 10 g/L;
• •24-hour urine M-protein is ≥ 200 mg;
• •Serum FLC is ≥ 5 mg/dL;
• •Plasmacytomas that can be evaluated by tests or imaging;
• •Bone marrow plasma cell percentage is ≥ 20%.
• •ECOG scores 0 - 1.
• •Adequate venous access for apheresis and venous blood sampling, and no other contraindications for leukapheresis.
• •WBC ≥ 1.5×10\^9/L;PLT ≥ 45×10\^9/L; Hb≥9.0g/dL
• •Serum creatinine ≤ 1.5 ULN.
• •ALT ≤ 2.5 ULN;AST ≤ 2.5 ULN. The above lab results should not include those obtained from continuous supportive treatment that is ongoing.