Relapsed or Refractory Multiple Myeloma
Conditions
Interventions
1:BCMA-CD38 Dual Chimeric Antigen Receptor (CAR)-Modified T Cells
Sponsors
Shenzhen Nanshan Hospital, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years old, regardless of gender; 2. Patients must meet the diagnostic criteria for relapsed or refractory multiple myeloma as defined by the IMWG(2017),who have received at least two courses of treatment, and progressed or relapsed after the last treatment; 3. Detection of bone marrow or plasmacytoma by flow cytometry or immunohistochemistry shows BCMA and/or CD38 expression on more than 50% of malignant plasma cells; 4. The disease can be measured at screening, and it meets any of the following definitions: Abnormal serum monoclonal protein (M protein) >= 1.0g/dL; Urine M protein >= 200mg/24h; Serum involvement FLC >= 10mg/dL and abnormal serum ?/? FLC ratio; 5. The toxicity of previous treatment must be stable and restored to = 1 x 10^9/L; Platelet count >= 50 x 10^9/L; Absolute lymphocyte count >= 100/µL; Hemoglobin >= 8.0g/dL; 8. Good functions of kidney, liver, lungs and heart; 9. Female patients around childbearing age, negative pregnancy test before trial, and agreed to take effective contraceptive measures during the trial until the last visit; 10. Voluntarily participate in this experiment and sign informed consent by themself, or legally authorized representative.
Exclusion criteria
Exclusion criteria: 1. Autologous or allogeneic stem cell transplantation was performed within 3 months prior to enrollment; 2. Asymptomatic myeloma (Smouldering Multiple Myeloma); 3. Previously received chimeric antigen receptor therapy or other lentivirus-mediated transgene therapy; 4. There are fungi, bacteria, viruses or other infections that cannot be controlled or that require anti-infective treatment; 5. Subjects requiring treatment with systemic corticosteroids (prednisone >= 5 mg/day, or equivalent doses of other corticosteroids) or other immunosuppressive drugs during the study, including treatment with MM (except for the treatment of adverse events); 6. Patients with HBV-DNA >= 100 IU/L or HIV or hepatitis C virus (anti-HCV positive) 7. There are any indwelling catheters or drainage tubes (such as percutaneous nephrostomy tube, indwelling urinary catheter, bile drainage tube or pleural/peritoneal/pericardial catheter), allowing the use of dedicated central venous catheters; 8. Malignant cells in the cerebrospinal fluid or brain metastases can be detected, or multiple myeloma is known to involve the meninges; 9. There is a history or disease of CNS, such as epileptic seizure disease, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving CNS; 10. There is a clinically significant cardiovascular disease, such as uncontrolled or symptomatic arrhythmia, congestive heart failure, or any heart function grade 3 (moderate) or grade 4 (severe) heart disease (according to the New York Heart Society function Classification method NYHA); persons with a history of myocardial infarction, cardiovascular angioplasty or stent implantation, unstable angina or other clinically significant heart diseases within 12 months before enrollment; 11. Subjects receiving hemodialysis or peritoneal dialysis; 12. Known to have primary immunodeficiency diseases (such as severe combined immunodeficiency disease, etc.); 13. People with a history of pulmonary embolism; 14. Have a history of severe hypersensitivity to the main therapeutic drugs in this study (including fludarabine, cyclophosphamide, mesna used during pretreatment, and anti-IL-6R monoclonal antibodies and anti-infective drugs for the prevention and treatment of CRS) 15. Pregnant or breastfeeding women; 16. Male and female subjects who are unwilling to take birth control measures within 6 months from the signing of the consent form to the completion of CAR-T administration; 17. Participating in other intervention studies; 18. According to the judgment of the investigator, the subject is unlikely to complete all the research visits or procedures required by the protocol, including follow-up visits or comply with the requirements for participating in the research; 19. In the past 2 years, there is a history of autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) that cause terminal organ damage or require systemic immunosuppressive/systemic disease modulating drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ;chimeric antigen receptor T-cell;ORR; | — |
Countries
China
Contacts
Public ContactLiqiong Liu
Department of Hematology, Shenzhen Nanshan Hospital, Huazhong University of Science and Technology
Outcome results
None listed