Multiple Myeloma
Conditions
Interventions
Low-dose group:CAR-T cells are infused intravenously
High-dose group:CAR-T cells are infused intravenously
the extended group:CAR-T cells are infused intravenously
Sponsors
The Affiliated Cancer Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Set of criteria for the participants, including the diagnosis of multiple myeloma patients with effective treatment options (such as autologous or allogeneic stem cell transplantation and in the existing overall survival after therapy is limited, specific requirements are as follows: 1. Subject aged 18 to 75 years for chinese people. 2. Documented diagnosis of multiple myeloma, according to the diagnostic criteria of IMWG. 3. Subjects must have measurable disease, including at least one of the criteria below: Serum M-protein greater or equal to 1.0 g/dL Urine M-protein greater or equal to 200 mg/24 h Serum free light chain (FLC) assay: involved FLC level greater or equal to 10 mg/dL (100 mg/L) provided serum FLC ratio is abnormal. 4. Must have received at least 3 prior MM treatment regimens, unless PD was the best response to the regimen, according to the diagnostic criteria of IMWG. 5. Must have received a proteasome inhibitor or an immunomodulatory agent. 6. In the recent myeloma therapy, during or after 12 months, the objective examination data demonstrates the disease progression. 7. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2. 8. Subject must have adequate organ functions and meet requirements on laboratory values: Hb >= 60g/L (no infusion of red blood cells before 7 days of Laboratory examination; allows the use of EPO); platelet count (PLT) >= 30x10^9/L (Not received infusion of blood components); PMN >= 0.75x10^9/L (Allows the use of growth factors, but not received the support treatment before 7 days of Laboratory examination); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =40 mL/min; Correction of serum calcium is 12.5 mg/dL or less or free calcium ions 6.5 mg/dL or less; 9. Recovery to Grade 1 or baseline of any non-hematologic toxicities due to prior treatments, excluding alopecia and Grade 2 neuropathy. 10. Fertile women in screening and treated with cyclophosphamide and fluorine for the first time#the high sensitivity of serum pregnancy test (beta human chorionic gonadotropin (beta hCG)) must be negative. 11. Whoever has the ability of fertility should be received effective medical contraception (both men and women, from signed informed consent to accept BCMA CAR-T cells therapy to 3 month after the infusion) 12. The subjects had to sign a consent form, shows that the understanding of the purpose of this study and the procedure, and willing to participate in research. 13. Obey the plan.
Exclusion criteria
Exclusion criteria: 1. Subjectis receive any CAR-T cell therapy . 2. Subjects receive BCMA targeted therapy. 3. Subjects have been diagnosed with or treated in addition to multiple myeloma of other invasive malignant tumor, except the following: received radical treatment of malignant tumor, and three years or more before signing the informed consent, without known active disease; Or through full treatment of non melanoma skin cancer, now there is no disease evidence; 4. Subjects ever received the following anti-tumor therapy (before signing the informed consent): within 5 half-lives or at least within 14 days (the shorter time shall prevail) received targeted therapies, epigenetic therapy or experimental drug therapy, or the use of invasive pilot medical apparatus and instruments. Cytotoxic therapy within 14 days. Proteasome inhibitor treated within 14 days. Immune regulator treatment within 7 days. Radiotherapy within 14 days. 5. Subjects with a history of class III or IV congestive heart failure (CHF) or severe non-ischemic cardiomyopathy, history of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia within the previous 6 months. 6. 2 weeks before signing the informed consent, subjects received prednisone therapy, the dose is greater than 60 mg/d (or the equivalent dose of corticosteroids) other systemic corticosteroids. 7. Subjects with known central nervous system involvement with myeloma. 8. Previous history of an allogeneic hematopoietic stem cell transplantation. 9. History or presence of clinically relevant central nervous system (CNS) pathology. 10. Subjects with active or history of plasma cell leukemia, fahrenheit, gigantic globulin hematic disease, POEMS syndrome (multiple neuropathy, viscera swelling, endocrine disease, monoclonal protein and skin changes) or primary AL amyloidosis. 11. Evidence of human immunodeficiency virus (HIV) infection. 12. Seropositive for and with evidence of active viral infection with hepatitis B virus (HBV). 13. Seropositive for and with evidence of active viral infection with hepatitis B virus (HBV) and Hepatitis C virus (HCV). 14. Six months before signing the informed consent subjects suffer stroke or seizure. 15. Four weeks before signing the informed consent vaccinated live attenuated, such as: live attenuated measles, live attenuated hepatitis a vaccine. 16. The subjects' check syphilis antibody and rapid plasma reagin syphilis is positive. 17. Need oxygen to maintain adequate blood oxygen saturation. 18. Known against BCMA CAR - T cells (SKB394) or its accessories (including dimethyl sulfoxide (DMSO)) have a life-threatening allergic reactions. 19. Serious diseases, such as: there are serious active virus infection, bacterial infection and/or uncontrolled systemic fungal infection;Active autoimmune disease or 3 years history of autoimmune disease. 20. Women during pregnancy or lactation. 21. Researchers believe subjects are unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety;ORR;CRR;PRR; | — |
Countries
China
Contacts
Public ContactSong Yongping
The Affiliated Cancer Hospital of Zhengzhou University
Outcome results
None listed