Status:
COMPLETED
CD19-CART Treatment for ALL
Lead Sponsor:
Bioray Laboratories
Collaborating Sponsors:
Second Xiangya Hospital of Central South University
Conditions:
Acute Leukemia
Eligibility:
All Genders
6-70 years
Phase:
PHASE1
PHASE2
Brief Summary
This study aims to evaluate the safety and efficacy of a novel CD19-CART in the treatment of refractory or recurrent ALL.
Detailed Description
Chimeric antigen receptor T cell (CART) is a kind of engineered immunotherapy by transferring an artificial antigen binding receptor and also intercellular co-stimulating molecules into T cells. This ...
Eligibility Criteria
Inclusion
- previously identified as CD19+ ALL.
- ALL patients not eligible for allogeneic SCT or relapse after allogeneic SCT.
- Expected survival \>12W.
- Creatinine \< 2.5 mg/dl.
- Alanine transaminase (ALT)/Aspartate Aminotransferase (AST) \< 3x normal
- Bilirubin \<2.0 mg/dl
- Voluntary informed consent is given.
Exclusion
- Pregnant or lactating women.
- Uncontrolled active infection.
- Active hepatitis B or hepatitis C infection.
- Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
- Previously treatment with any gene therapy products.
- Any uncontrolled active medical disorder that would preclude participation as outlined.
- HIV infection.
Key Trial Info
Start Date :
August 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2020
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03232619
Start Date
August 1 2018
End Date
September 15 2020
Last Update
September 22 2020
Active Locations (1)
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1
Shanghai Bioray Inc.
Shanghai, Shanghai Municipality, China, 200240