This is an open label, phase I study to assess the safety and efficacy of CLL1 CAR-T in patients with relapsed and refractory acute myeloid leukemia
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
A single infusion of autologous CLL1 CAR-T cells administered intravenously
The First Affiliated Hospital, Zhejiang University
Hangzhou, China
Evaluation of Safety
Count the Incidence of adverse events
Time frame: Up to 2 years after CLL1 CAR-T infusion
Changes in cytokine level after CLL1 CAR-T infusion
Calculate the change of cytokine level in peripheral blood by flow cytometry after CLL1 CAR-T infusion. Cytokines include IL-2、IL-6、IL-10、IFN-γ.
Time frame: Up to 2 years after CLL1 CAR-T infusion
Complete response rate(CRR)
Proportion of subjects who achieved morphological complete response (CR) and complete response with hematologic incomplete recovery (CRi)
Time frame: Up to 2 years after CLL1 CAR-T infusion
Partial response Rate (PRR)
Proportion of subjects who achieved a partial response (PR)
Time frame: Up to 2 years after CLL1 CAR-T infusion
Overall response Rate(ORR)
Proportion of subjects who achieved CR, CRi, or PR
Time frame: Up to 2 years after CLL1 CAR-T infusion
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