The Safety and Efficacy of CART-19 Cells in B-cell Acute Lymphoblastic Leukemia (B-ALL).

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a study for patients who have been previously treated for B-ALL. The purpose of this study is to determine the safety and feasibility of CART-19 cells to the patients with relapsed and refractory CD19+ B-ALL.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henan Cancer Hospital
• Collaborator: The Beijing Pregene Science and Technology Company, Ltd.
• Treatments: Cyclophosphamide; Fludarabine; Fludarabine phosphate

Criteria

Inclusion Criteria:

1. 4 years to 70 years, expected survival > 3 months

2. CD19 positive B-cell acute lymphoblastic leukemia

3. Karnofsky Performance Status (KPS) >70

4. Relapsed after allogeneic or autologous stem cell transplantation (SCT);

5. Cardiac function: 1-2 levels; Liver: TBIL≤3 Upper Limit of Normal (ULN)，aspartate aminotransferase (AST) ≤2.5 ULN，ALT ≤2.5 ULN; kidney: Cr≤1.25 ULN; bone marrow: White Blood Cell (WBC) ≥ 3.0×109/L, Hb ≥90 g/L, Platelet (PLT) ≥ 80×109/L）

6. No serious allergic constitution

7. No other serous diseases that conflicts with the clinical program

8. No other cancer history

9. No serious mental disorder

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

Exclusion Criteria:

1. Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test)

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. Transaminase >2.5 ULN, Bilirubin >3 ULN，Creatinine>1.25 ULN

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

8. Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results