Multiple myeloma
Conditions
Interventions
Low dose group:1.0*10^6 CAR+T cells/kg
High dose group:5.0*10^6 CAR+T cells/kg
Sponsors
Shanxi Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Participants must meet all of the following criteria for the can into the group of this study: 1. Volunteered for the clinical study, understanding and knowledge of this study and signed informed consent, and willing to finish all the test procedure. 2. Aged >= 18 years, gender not limited; 3. According to IMWG diagnostic criteria for diagnosis of multiple myeloma patients; 4. ECOG score 2 points or less; 5. Recurrence in patients with multiple myeloma: always received at least 3 lines for patients with disease progression after treatment (including the proteasome inhibitors and immune modulators); In patients with refractory multiple myeloma: early treatment has never reached more than MR and curative effect; Or early treatment has reached more than MR and curative effect, but the subsequent treatment process or within 60 days after the last treatment disease progress; 6. Screening are measurable lesions (conform to one of the following standards: (1) the serum M protein: IgG protein, 10 g/L or higher, or IgA M protein 5 g/L or higher, or IgD M protein 5 g/L or higher; (2) M protein urine or 200 mg / 24 hours. (3) such as serum or urine M protein is measured, is under the condition of the abnormal serum free light chain ratio of serum immunoglobulin free light chain or 100 mg/L; 7. When screening test results: (1) blood routine: 60 g/L or higher hemoglobin (7 days before the inspection without blood transfusion), platelet 50 x 10 ^9 or higher/L (7 days before the inspection without blood transfusion), lymphocyte acuity 0.3 * 10^9 / L, and neutrophil count acuity 0.75 * 10^9 / L; (2) the liver and kidney function, cardiopulmonary function meet the following requirements; ALT, AST 3 or less uln, total bilirubin 2 or less uln (except congenital bilirubin in patients with anemia, such as Gilbert's syndrome). The endogenous creatinine clearance 30 ml/min / 1.73 m2 or; Correction of serum calcium or less tendency for 3.1 / L (12.5 mg/dL) or less; Left ventricular ejection fraction 40% or higher; Baseline peripheral blood oxygen saturation 95% or higher; 8. Have fertile women screening period, qing shower before pregnancy blood test results are negative; 9. Survival is expected to more than 3 months.
Exclusion criteria
Exclusion criteria: Comply with any of the following items were not into the group of patients exclusion criteria: 1. The active hepatitis b, HBV - DNA detection lower limit of the subjects above research center; Hepatitis c virus (HCV) antibody positive and peripheral blood HCV - RNA positive subjects; Antibodies to HIV positive people; Early syphilis screening antibody positive; 2. There are other significant clinical significance of active virus, bacterial infection, or failing to control systemic fungal infection; 3. Any instability of systemic disease, including but not limited to, unstable angina, cerebrovascular accident, or transient ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), New York heart association (NYHA) classification level III or higher congestive heart failure, drug control of serious arrhythmia, liver, kidney or metabolic diseases, as well as the standard treatment cannot control high blood pressure; 4. In the past two years, because of autoimmune diseases such as crohn's disease, rheumatoid arthritis and systemic lupus erythematosus (sle), etc.) causing end-organ damage, or need systemic application of immunosuppressive drugs; 5. A history of the central nervous system diseases, such as epilepsy, serious brain damage, dementia, Parkinson's disease, psychosis, such as impact test evaluation of disease; 6. Always with other active malignancy within five years (have to cure and does not require follow-up treatment of basal or scaly skin cancer, except for superficial bladder cancer, breast cancer in situ); 7. Known for cyclophosphamide, fluorine dara marina or CAR - T cell preparation including accessories, DMSO patients with severe allergic reactions; 8 patients with pregnancy or lactation, the cells back within 6 months after losing patients are reluctant to take effective contraceptive measures; 9. Other researchers determine doesn't fit to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 0RR;MRD negative percentage, and duration; | — |
Secondary
| Measure | Time frame |
|---|---|
| DOR;PFS;OS; | — |
Countries
China
Contacts
Public ContactLiping Su
Shanxi Cancer Hospital
Outcome results
None listed