Targeting CD19 and CD22 CAR-T Cells Immunotherapy in Patients With Relapsed or Refractory Acute B Lymphocytic Leukemia

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    24
  • sponsor
    Shanxi Province Cancer Hospital
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Updated on 29 January 2021
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Summary

Evaluation the safety,tolerability, preliminary efficacy,and PK/PD of CD19-CD22 CAR-T cells for the treatment of acute B lymphocytic leukemia.

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 groupsto evaluate the safety and tolerability of CD19-CD22 CAR - T cellsto evaluate the preliminary efficacy and observe PK/PD parameters of CD19-CD22 CAR -T cells immunotherapy in patients with relapsed or refractory acute B lymphocytic leukemia .

Details
Condition Acute Lymphocytic Leukemia， B-Cell
Treatment CD19-CD22 CAR-T cells
Clinical Study IdentifierNCT04714593
SponsorShanxi Province Cancer Hospital
Last Modified on29 January 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

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) Hb60 g/L (allowed to use recombinant human erythropoietin); PLT 50 x 10 ^ 9 / L ; ALC0.310^9/L; ANC0.7510^9/L (allowed to use granulocyte colony stimulating factor); AST3ULN,ALT3ULN,TBIL2ULNCcr30 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 Criteria

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
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