Overview

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