Status:
UNKNOWN
CD19 CAR-T Cells for Patients With Relapse and Refractory CD19+ B-ALL.
Lead Sponsor:
Henan Cancer Hospital
Collaborating Sponsors:
The Pregene (ShenZhen) Biotechnology Company, Ltd.
Conditions:
B-cell Acute Lymphocytic Leukemia
Eligibility:
All Genders
2-70 years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed Description
Upon meeting the eligibility requirements and enrolling on study, Subjects will be collected large numbers of peripheral blood mononuclear cells (PBMC) for the generation of the CD19 CAR-T cells. The ...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
August 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03263208
Start Date
August 16 2017
End Date
July 1 2019
Last Update
October 20 2017
Active Locations (2)
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1
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
2
Henan Cancer Hospital
Zhengzhou, Henan, China