Multiple myeloma
Conditions
Interventions
Low dose level :Infuse 0.5×10^6 CAR+ T Cells/kg
Middle dose level :Infuse 1.0×10^6 CAR+ T Cells/kg
High dose level:Infuse 2.0×10^6 CAR+ T Cells/kg
Sponsors
Zhongshan People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in clinical trial; 2. Aged >=18 years men and women; 3. Previously received at least 3 regimens to treat multiple myeloma, including at least one proteasome inhibitor and an immunomodulator, and after the above treatment, they did not reach PR (PR (partial remission)): (1) serum M Protein reduction >=50%, 24 hours urine M protein reduction >=90% or to =50% to replace the M protein standard; (3) If the serum protein and urine M protein and serum FLC are not measurable, and the baseline bone marrow plasma cell ratio is >=30%, the number of bone marrow plasma cells is required to be reduced by 50% or more; (4) In addition to the above criteria, if soft tissue plasmacytoma is present at the baseline, it is required that the measurable lesion SPD (the sum of the maximum vertical diameter product) be reduced by 50% or more.); 4. Expected survival time> 12 weeks; 5. ECOG score 0-1 points; 6. Adequate venous access for apheresis; 7. Sufficient liver and kidney function, cardiovascular and respiratory function; 8. Women of childbearing age must undergo a serum pregnancy test at the time of screening and before receiving cyclophosphamide and fludarabine treatment with a negative result; 9. Male subjects are willing to use very effective and reliable methods of contraception within 1 year of using study treatment.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. HBV sAg, HCV-RNA, HIV antibody or syphilis serology test positive; 3. Any uncontrollable active infection; 4. The toxic and side effects caused by the subject's previous treatment did not return to CTCAE = 1 level; 5. Have ever received CAR-T therapy for any target; 6. Have ever received any treatment that targets CD19 and / or BCMA; 7. For the treatment of multiple myeloma, have previously received allogeneic stem cell transplantation; 8. Have received autologous stem cell transplantation within 12 weeks before apheresis; 9. Receive treatment for the research disease within 14 days of apheresis; 10. Receive systemic steroids equivalent to> 15 mg of prednisone within 14 days of aspirin; 11. Plasma cell leukemia, Fahrenheit macroglobulinemia, POEMS syndrome, or primary light chain amyloidosis at the time of screening; 12. Live attenuated vaccine within 4 weeks before apheresis; 13. Allergy or intolerance to fludarabine, cyclophosphamide, tocilizumab; 14. Uncontrollable cardiovascular and cerebrovascular diseases in the 6 months before signing the informed consent; 15. Left ventricular ejection fraction (LVEF) =95%; 18. Have other uncured malignancies in the past 5 years or at the same time; 19. suffering from a known symptomatic CNS disease; 20. The researcher evaluates that the subject is unable or unwilling to comply with the requirements of the research protocol; 21. Major surgery performed within 2 weeks before apheresis; 22. Relatives of the researcher or his staff, subjects who may have a stake in the researcher or his staff.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity; | — |
Countries
China
Contacts
Public ContactZiwen Guo
Zhongshan People's Hospital
Outcome results
None listed