Status:
UNKNOWN
Anti-CLL1 CAR T-cell Therapy in CLL1 Positive Relapsed/Refractory Acute Myeloid Leukemia (AML)
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 anti-CLL1 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CLL1 positive ...
Detailed Description
The patients will receive infusion of anti-CLL1 CAR T-cells to confirm the safety and efficacy of anti-CLL1 CAR T-cells in relapsed or refractory acute myeloid leukemia.
Eligibility Criteria
Inclusion
- CLL1 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 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04884984
Start Date
July 1 2017
End Date
December 31 2024
Last Update
May 13 2021
Active Locations (1)
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1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006