Acute B lymphocytic leukemia
Conditions
Interventions
Low dose group:1.0 x 10^5 CAR + T Cell/kg
Middle dose group:5.0 x 10^5 CAR + T Cell/kg
High dose group:2×10^6 CAR+T Cell/kg
Amplification dose group:1.0×10^5 to 2×10^6 CAR+T Cell/kg
Sponsors
Shanxi Cancer Hospital
Eligibility
Sex/Gender
All
Age
6 Years to 70 Years
Inclusion criteria
Inclusion criteria: All participants must satisfy the following criteria can into groups: 1. 6-70 -year- old male or female subjects (contains 6 and 70 years old, 6-18 subjects only recommended dose treatment); 2. Clinical diagnosis of recurrent/refractory acute B lymphocytic leukemia, after 2 courses of treatment at least part of ease, still in the continuous phase and progress including tiny residual (MRD) positive; Or intramedullary recurrence patients; 3. Flow cytometry or histopathologic bone marrow samples tested positie CD19 cell membrane surface antigens and/or CD22; 4. ECOG score of 0 to 2 points; 5. Expected lifetime is more than 12 weeks; 6. The screening of clinical laboratory tests (without blood transfusion) 7 days before the results meet the following criteria: Before 60 g/L or higher hemoglobin (allows the use of recombinant human erythropoietin); The platelet count 50 x 10^9/L or higher; Lymphocyte acuity 0.3 * 10^9/L; Neutrophil count absolutely acuity 0.75 * 10^9/L (allows the use of granulocyte colony stimulating factor); Aspartate aminotransferase (AST) or less 3 times the upper limit of normal (ULN); Alanine aminotransferase (ALT)3 x ULN or less; Total bilirubin 2 x ULN or less; Creatinine clearance 30 mL/min / 1.73 m2 or; 7. Cardiopulmonary function: left ventricular ejection fraction > 40%; Baseline blood oxygen saturation > 95%; 8. Has a history of allogeneic/allogeneic hematopoietic stem cell transplantation patients: transplantation in 3 months ago, no grade 2 or more active graft versus host disease (GVHD), more than a month without immune inhibitors.
Exclusion criteria
Exclusion criteria: Comply with any of the following items were not into the group of patients exclusion criteria: 1. The active hepatitis b, HBV - DNA detection lower limit of the subjects above research center; Hepatitis c virus (HCV) antibody positive and peripheral blood HCV - RNA positive subjects; Antibodies to HIV positive people; Early syphilis screening antibody positive; 2. There are other significant clinical significance of active virus, bacterial infection, or failing to control systemic fungal infection; 3. Any instability of systemic disease, including but not limited to, unstable angina, cerebrovascular accident, or transient ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), New York heart association (NYHA) classification level III or higher congestive heart failure, drug control of serious arrhythmia, liver, kidney or metabolic diseases, as well as the standard treatment cannot control high blood pressure; 4. In the past two years, because of autoimmune diseases such as crohn's disease, rheumatoid arthritis and systemic lupus erythematosus (sle), etc.) causing end-organ damage, or need systemic application of immunosuppressive drugs; 5. A history of the central nervous system diseases, such as epilepsy, serious brain damage, dementia, Parkinson's disease, psychosis, such as impact test evaluation of disease; 6. Always with other active malignancy within five years (have to cure and does not require follow-up treatment of basal or scaly skin cancer, except for superficial bladder cancer, breast cancer in situ); 7. Known for cyclophosphamide, fluorine dara marina or CAR - T cell preparation including accessories, DMSO patients with severe allergic reactions; 8 patients with pregnancy or lactation, the cells back within 6 months after losing patients are reluctant to take effective contraceptive measures; 9. Other researchers determine doesn't fit to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS/DFS;ORR;OS;DOR; | — |
Countries
China
Contacts
Public ContactLiping Su
Shanxi Cancer Hospital
Outcome results
None listed