Status:
UNKNOWN
Targeting CD19 and CD22 CAR-T Cells Immunotherapy in Patients With Relapsed or Refractory Acute B Lymphocytic Leukemia
Lead Sponsor:
Shanxi Province Cancer Hospital
Collaborating Sponsors:
Shanghai Ultra-T Immune Therapeutics Co. LTD
Conditions:
Acute Lymphocytic Leukemia， B-Cell
Eligibility:
All Genders
6-70 years
Phase:
PHASE1
PHASE2
Brief Summary
Evaluation the safety,tolerability, preliminary efficacy,and PK/PD of CD19-CD22 CAR-T cells for the treatment of acute B lymphocytic leukemia.
Detailed Description
A non randomized study ,plans to enrollment 24 subjects of acute B lymphocytic leukemia .The subjects will divide into low, medium and high dose groups，to evaluate the safety and tolerability of CD19-...
Eligibility Criteria
Inclusion
- 6-70 - year - old male or female subjects (including 6 years old and 70 years old, 6-18 subjects use only the recommended dose of treatment);
- The Clinical diagnosis of recurrent/refractory acute B lymphocytic leukemia, after at least 2 courses of treatment, has not been achieved partial response, still in the continuous phase and progress, including the MRD positive, or recurrent intramedullary patients；
- Bone marrow samples inspection by using flow cytometry or organization pathology ，the cell membrane surface antigen CD19 and/or CD22 positive；
- ECOG physical status score of 0 to 2 points;
- Expected lifetime is more than 12 weeks;
- The clinical laboratory test results of screening phase meet the following criteria: (7 days before the inspection without blood transfusion) Hb≥60 g/L (allowed to use recombinant human erythropoietin); PLT≥ 50 x 10 \^ 9 / L ; ALC≥0.3×10\^9/L; ANC≥0.75×10\^9/L (allowed to use granulocyte colony stimulating factor); AST≤3ULN,ALT≤3ULN,TBIL≤2ULN；Ccr≥30 mL/min/1.73 m2；
- Cardiopulmonary function: left ventricular ejection fraction \> 40%; Baseline blood oxygen saturation \> 95%;
- 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
- 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 subjects; Early syphilis screening antibody positive;
- The other clinical significance of active virus, bacterial infection, or failing to control systemic fungal infection;
- 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;
- In 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;
- Had a history of the central nervous system diseases, such as epilepsy, serious brain damage, dementia, Parkinson's disease, psychosis,etc which influence the appraising of test,;
- Diagnosed with other active malignancy in past five years(the basal or scaly skin cancer, superficial bladder cancer, breast cancer in situ, which has been cured and does not require follow-up treatment are not included );
- Known allergic to cyclophosphamide, fluorine dara marina or CAR - T cell s including accessories, DMSO ;
- Patients with pregnancy or lactation, patients do not want to take effective contraceptive measures within 6months after infusion CAR-T cells;
- The other situations that researchers determined doesn't fit to participate in this study.
Key Trial Info
Start Date :
January 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04714593
Start Date
January 15 2021
End Date
December 31 2023
Last Update
January 22 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hematology Department of ShanXi Cancer Hospital
Taiyuan, Shanxi, China, 030013