Relapsed or Refractory Multiple Myeloma (MM)
Conditions
Interventions
Case series:BCMA CART
Sponsors
Henan Province Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 years male and female; 2. Patients with relapsed or refractory myeloma that must meet the IMWG Multiple Myeloma Diagnostic Criteria (2016) that meet the following criteria: (1) Subjects undergoing adequate prior treatment with at least 2 regimens (Note: 1 induction regimen, stem cell transplant and maintenance treatment if no disease progression is present); (2) disease progression (PD) or recurrence during or at the end of the most recent treatment (as judged by the investigator based on the 2016 version of IMWG criteria, Appendix A); 3. Flow cytometry or immunohistochemical detection of bone marrow or plasmacytoma specimens required> 50% of malignant plasma cells can be detected BCMA expression; 4. Screening disease measurable, which meets any of the following definitions: (1) serum monoclonal abnormal protein (M protein) level = 1.0 g/dL; (2) Urine M protein level =200 mg/24 h; (3) Serum FLC = 10 mg/dL and abnormal serum ?/? FLC ratio; 5. The toxicity resulting from previous treatment must be stable and returned to =1 (except clinically significant toxicity, such as hair loss); 6. Eastern Cooperative Oncology Group (ECOG) physical status score of 0 to 2 (tumor-induced bone pain, except); 7. Absolute neutrophil count = 1×10^9/L; 8. Platelet count = 50×10^9/L; 9. Absolute lymphocyte count = 100/uL; 10. Hemoglobin = 8.0 g/dl; 11. Kidney, liver, lung and heart functionally adequate, defined as follows: (1) Creatinine clearance (estimated by Cockcroft Gault method) =30 mL / min, serum creatinine =2.5 mg / dL; (2) serum ALT / AST = 2.5 times the upper limit of normal; (3) Total bilirubin = 2 times upper limit of normal except for subjects with Gilbert's disease; (4) Cardiac ejection fraction = 45%, echocardiography confirmed no pericardial effusion, no clinically significant ECG findings; There is no clinically significant pleural effusion (5) Baseline oxygen saturation> 92% when indoors; 12. Fertility women must have a serum or urine pregnancy test that is negative (women who have undergone sterilization or who have been at least 2 years post-menopausal may be considered unproductive); 13. Sign the informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1. Autologous or allogeneic stem cell transplantation (SCT) was performed within 3 months prior to enrollment; 2. Asymptomatic myeloma (Smoldering Multiple Myeloma); 3. Previously received BCMA targeted cell therapy; 4. Previously received chimeric antigen receptor therapy or other transgenic T cell therapy; 5. There are fungi, bacteria, viruses or other infections that can not be controlled or require anti-infective treatment. 6. Subjects to be treated with systemic corticosteroid therapy (=5 mg / d of prednisone or equivalent corticosteroid doses) or other immunosuppressive drugs during the study, including treatment with MM, for treatment failure Except for events 7. Known to be HIV or HBsAg positive or anti-HCV positive [Note: Hepatitis B (HBsAg positive) or Hepatitis C virus (anti-HCV positive) in patients, even if no detectable viral load can not be enrolled] ; 8. There are any indwelling catheters or drains (eg, percutaneous nephrostomy tubes, indwelling catheters, bile ducts, or pleural / peritoneal / pericardial catheters). Allow use of a dedicated central venous catheter; 9 can detect cerebrospinal fluid malignant cells or brain metastases, or known multiple myeloma involving the meninges; 10. There is a CNS history or disease, such as seizure disease, cerebrovascular ischemia / hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving the CNS; 11. There are clinically significant cardiovascular diseases, such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or any cardiac function Grade 3 (moderate) or grade 4 (severe) heart disease (according to New York Heart Association function Grading method NYHA); myocardial infarction, angioplasty or stenting, unstable angina pectoris or other clinically relevant history of heart disease within 12 months before enrollment; 12. Subjects undergoing hemodialysis or peritoneal dialysis; 13. Known is the existence of primary immunodeficiency disease (such as severe combined immunodeficiency disease, etc.); 14 have a history of pulmonary embolism; 15. Have a history of severe hypersensitivity reactions to the major therapeutic agents used in this study, including fludarabine, cyclophosphamide, mesna, and tocilizumab in the prevention and treatment of CRS and anti-infectives during the pretreatment; 16. Pregnant or lactating women; 17. Male and female subjects who are unwilling to take birth control measures within six months from the signing of the consent form until completion of the administration of BCMA-CART; 18. are participating in other interventional studies; 19. At the investigator's discretion, subjects were less likely to complete the study visits or procedures required for all programs, including follow-up visits or compliance with the study participation requirements; 20. Over the past 2 years there is a history of autoimmune diseases (eg, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) leading to damage to the terminal organ or requiring systemic immunosuppressive / systemic disease modifying drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tumor burden in bone marrow; | — |
Countries
China
Contacts
Public ContactBaijun Fang
He'nan Provincial Tumor Hospital
Outcome results
None listed