Overview

CD19 CAR-T Cells for Patients With Relapse and Refractory CD19+ B-ALL.

Status:
Unknown status
Trial end date:
2019-07-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to infusion CD19 CAR-T cells to the patients with relapsed and refractory CD19+ B cell leukemia, to assess the safety and feasibility of this strategy. The CAR enables the T cell to recognize and kill the leukemic cell through the recognition of CD19, a protein expressed of the surface of the leukemic cell in patients with CD19+ leukemia.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Henan Cancer Hospital
Collaborator:
The Pregene (ShenZhen) Biotechnology Company, Ltd.
Treatments:
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Criteria
Inclusion Criteria:

- 1. 2 years to 70 years, expected survival > 3 months;

- 2. CD19 positive B-cell acute lymphoblastic leukemia;

- 3. ECOG < 2；

- 4. The tumor load in the bone marrow is less than 60%;

- 5. Cardiac function: 1-2 levels; Liver: TBIL≤3ULN，AST ≤2.5ULN，ALT ≤2.5ULN; kidney:
Cr≤1.25ULN; Peripheral Blood: WBC ≥ 2.0×109/L, Hb ≥80 g/L, PLT ≥ 30×109/L）;

- 6. No leukemia cells in the central nervous system;

- 7. No serious allergic constitution;

- 8. No other serous diseases that conflicts with the clinical program;

- 9. No other cancer history;

- 10. No serious mental disorder;

- 11. female participants of reproductive potential must have a negative serum pregnancy
test;

- 12. Informed consent is signed by a subject or his lineal relation.

Exclusion Criteria:

- 1. Pregnant or lactating women;

- 2. Uncontrolled active infection, HIV infection, syphilis serology reaction positive;

- 3. Active hepatitis B or hepatitis C infection;

- 4. Recent or current use of glucocorticoid or other immunosuppressor;

- 5. With severe cardiac, liver, renal insufficiency, diabetes and other diseases;

- 6. Participate in other clinical research in the past three months; previously
treatment with any gene therapy products;