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
Shanghai Changzheng Hospital Onset
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be enrolled in this study: 1. The subjects who voluntarily participate in the clinical study know and know about the study and sign the informed consent, and are willing to complete all the trial procedures. 2. Subjects aged 18 or above, regardless of gender; 3. Patients diagnosed as multiple myeloma according to IMWG diagnostic criteria; 4. Subjects with ECoG score = 10 g / L, IgA type M protein >= 5 g / L, or IgD type M protein >= 5 g / L; (2) Urine M protein >= 200mg / 24h; (3) If M protein in serum or urine can not be measured, the free light chain of serum immunoglobulin is more than or equal to 100 mg / L when the ratio of serum free light chain is abnormal; 7. Screening results: (1) Blood routine: hemoglobin >= 60g / L (no blood transfusion 7 days before examination), platelet >= 50 * 10^9 / L (no blood transfusion 7 days before examination), lymphocyte >= 0.3 * 10^9 / L, neutrophil count >= 0.75 * 10^9 / L; (2) Liver and kidney function, cardiopulmonary function meet the following requirements; alt, AST = 30ml / min / 1.73m2; corrected serum calcium = 40%; baseline peripheral oxygen saturation >= 95%; 8. The results of blood pregnancy test in screening period and pre - gonorrhea of fertile women were negative; 9. Subjects with an expected survival of more than 3 months.
Exclusion criteria
Exclusion criteria: Patients who met any of the following exclusion criteria were excluded from the study 1. Subjects of pregnant or lactating women; 2. Active hepatitis B, active hepatitis C, HIV / AIDS infection, syphilis positive patients; other active infection with significant clinical significance; 3. Subjects with the following previous or concomitant diseases: Patients who were diagnosed as severe autoimmune diseases and met any of the following exclusion criteria were excluded from the study: (1) Subjects of pregnant or lactating women (2) Active hepatitis B, active hepatitis C, HIV / AIDS infection, syphilis test positive; other significant clinical significance of active infection; (3) Subjects with the following previous or concomitant diseases: Subjects diagnosed with severe autoimmune diseases need systemic immunosuppressive therapy (steroids) for a long time (more than 2 months), or have immune-mediated symptomatic diseases, including ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus (SLE), autoimmune vasculitis (such as Wegener's granulomatosis); Patients with any mental illness, including dementia and mental state changes, may affect the informed consent and understanding of the questionnaire; (4) Subjects with central nervous system involvement; (5) Subjects allergic to immunotherapy or related drugs; (6) Subjects with any unstable systemic disease: including but not limited to unstable angina pectoris, cerebrovascular accident or transient cerebral ischemia (within 6 months before screening), myocardial infarction (within 6 months before screening), congestive heart failure (NYHA classification = III), severe arrhythmia requiring drug treatment, liver, kidney or metabolic disease (7) The subjects who had received car-t therapy or other gene modified cell therapy before screening; (8) Other subjects judged by researchers not suitable for this study need systemic immunosuppressant (steroid) treatment for a long time (more than 2 months), or have immune-mediated symptomatic diseases, including ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus (SLE), autoimmune vasculitis (such as Wegener's granulomatosis); Patients with any mental illness, including dementia and mental state changes, may affect the informed consent and understanding of the questionnaire; 4. Subjects with central nervous system involvement; 5. Subjects allergic to immunotherapy or related drugs; 6. Subjects with any unstable systemic diseases: including but not limited to unstable angina pectoris, cerebrovascular accident or transient cerebral ischemia (within 6 months before screening), myocardial infarction (within 6 months before screening), congestive heart failure (NYHA classification >= III), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases; 7. The subjects who had received car-t or other gene modified cell therapy before screening; 8. Other subjects judged by the researcher not suitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 0RR; | — |
Secondary
| Measure | Time frame |
|---|---|
| MRD negative percentage, and duration;DOR;PFS;OS; | — |
Countries
China
Contacts
Public ContactWeijun Fu
Hematology Department of Shanghai Changzheng Hospital
Outcome results
None listed