R/RMultiple myeloma
Conditions
Interventions
High dose level: 2.0×10^6 UCAR+ T Cells/kg
Sponsors
Zhongshan People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in clinical trials; 2. Age from 18 to 70 years old (including the cut-off value), regardless of gender; 3. The subjects tumor specimens (blood, bone marrow or plasmacytoma specimens) have been tested by immunohistochemistry (IHC) or flow cytometry to detect positive BCMA expression on the plasma cell membrane; 4. Those who have not achieved complete remission after standard chemotherapy, or relapse early after complete remission; 5. The estimated survival time is not less than 2 months; 6. ECOG score 0-2 points; 7. Liver and kidney function, heart and lung function meet the following requirements: a) Creatinine is within the normal range; b) Left ventricular ejection fraction > 50%; c) Baseline blood oxygen saturation > 92%; d) Total bilirubin <= 2 times the upper limit of normal; ALT and AST <= 2.5 times the upper limit of normal; 8. Female subjects of childbearing age must undergo a serum pregnancy test and the result is negative during screening and before receiving cyclophosphamide and fludarabine treatment; 9. Male subjects are willing to use a very effective and reliable method of contraception within 1 year after using the study treatment.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Subjects with positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood HBV DNA titer test >= 3 x 10^2 copies/L; hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; HIV antibody positive; CMV DNA test positive; syphilis test positive; 3. Any uncontrollable active infection; 4. The toxic and side effects caused by the subject's previous treatment have not recovered to CTCAE <= 1; 5. Have received allogeneic stem cell transplantation in the past; 6. Suffered from plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome or primary light chain amyloidosis during screening; 7. Allergy or intolerance to fludarabine, cyclophosphamide, tocilizumab; 8. Uncontrollable cardiovascular and cerebrovascular diseases within 6 months before signing the informed consent; 9. Left ventricular ejection fraction (LVEF) < 45% at screening; 10. Suffer from active autoimmune diseases; 11. Suffered from other uncured malignant tumors within the past 5 years or at the same time; 12. Suffer from known symptomatic CNS disease; 13. The investigator assesses that the subject is unable or unwilling to comply with the requirements of the research protocol; 14. Relatives of the investigator or its staff, and subjects who may have interests related to the investigator or its staff. 15. Those who have graft versus host disease (GVHD) or need to use immunosuppressive agents.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in tumor lesions;Immunogenicity;Overall response rate;Overall survival;Progression-free survival;Overall response time; | — |
Countries
China
Contacts
Public ContactZiwen Guo
Outcome results
None listed