Status:
UNKNOWN
CD38-targeted Chimeric Antigen Receptor T Cell (CART) in Relapesd or Refractory Acute Myeloid Leukemia
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
6-65 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a single center, open-label phase 1/2 study to evaluate the safety and efficacy of targeted CD38 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CD38 posit...
Detailed Description
The patients will receive infusion of CAR T-cells targeting CD38 to confirm the safety and efficacy of CD38 CAR T-Cells in relapsed or refractory acute myeloid leukemia.
Eligibility Criteria
Inclusion
- CD38 positive relapsed/refractory acute myeloid leukemia
- age 6-65 years.
- left ventricular ejection fractions ≥ 0.5 by echocardiography
- creatinine \< 1.6 mg/dL
- aspartate aminotransferase/aspartate aminotransferase \< 3x upper limit of normal
- Total bilirubin \<2.0 mg/dL
- karnofsky performance status ≥ 60
- expected survival time ≥ 3 months (according to investigator's judgement)
Exclusion
- patients are pregnant or lactating
- uncontrolled active infection
- class III/IV cardiovascular disability according to the New York Heart Association Classification
- active hepatitis B or hepatitis C infection
- patients with HIV infection
- patients with history of seizure
- active central nervous system leukemia
Key Trial Info
Start Date :
July 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04351022
Start Date
July 1 2017
End Date
December 31 2023
Last Update
April 24 2020
Active Locations (1)
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1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China