This is an open label, phase I study to assess the safety and efficacy of ADGRE2 CAR-T in patients with relapsed and refractory acute myeloid leukemia
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
ADGRE2 CAR-T is a new type CAR-T cells therapy for patients with acute myeloid leukemia.
Mingming Zhang Zhang
Hangzhou, China
Changes in cytokine level after ADGRE2 CAR-T infusion.
Calculate the change of cytokine level in peripheral blood by flow cytometry after CAR-T infusion. Cytokines include IL-2、IL-6、TNF-α、IFN-γ.
Time frame: Up to 2 years after ADGRE2 CAR-T infusion
The change characteristics of chimeric antigen receptor(CAR)-T cell number and copy number in patients after infusion.
Track CAR-T cells expansion in patients after infusion by flow cytometry and qPCR.
Time frame: Up to 2 years after ADGRE2 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 ADGRE2 CAR-T infusion
Partial response Rate (PRR)
Proportion of subjects who achieved a partial response (PR)
Time frame: Up to 2 years after ADGRE2 CAR-T infusion
Overall response Rate(ORR)
Proportion of subjects who achieved CR, CRi, or PR
Time frame: Up to 2 years after ADGRE2 CAR-T infusion
He Huang, MD
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