This is a single-center, single-arm, open, intravenous drug administration of the safety and efficacy of clinical study.
The primary objective of the clinical trial was to evaluate the safety and efficacy of single dose infusion of anti-CLL1 /+CD33 CAR T cells in patients with refractory/recurrent acute myeloid leukemia. A total of about 5 patients with refractory/recurrent acute myeloid leukemia were enrolled in this study, and the target dose range was 1.00\~2.50x10\^6/kgCAR-positive T cells.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
CLL1/+CD33 CAR T is a type of CAR T cell therapy for patients with treating/relapsed acute myeloid leukemia.
Fujian Provincial Children's Hospital
Fuzhou, Fujian, China
Changes in cytokine level after CLL1/+CD33 CAR-T infusion
Calculate the change of cytokine level in peripheral blood by flow cytometry after CAR-T infusion.
Time frame: CAR T cell infusion before and 12 months after infusion
The change characteristics of chimeric antigen receptor(CAR)-T cell number in patients after infusion.
Track CAR-T cells expansion in patients after infusion by flow cytometry
Time frame: CAR T cell infusion before and 12 months after infusion
The change characteristics of chimeric antigen receptor(CAR)-T cell copy number in patients after infusion.
Track CAR-T cells expansion in patients after infusion by Real-time Quantitative Polymerase Chain Reaction(qPCR)
Time frame: CAR T cell infusion before and 12 months after infusion
Event-free survival
Counting from the beginning of cell transfusion until treatment failure, recurrence, or death (various causes). Subjects without any of these events were counted up to the last follow-up examination date. For patients without CR or CRi, EFS is calculated from the beginning of cell transfusion until disease progression or death. Based on the initial event.
Time frame: Up to 12 months after CLL1/+CD33 CAR-T infusion
Overall survival
Death from any cause from the beginning of cell transfusion
Time frame: Up to 12 months after CLL1/+CD33 CAR-T infusion
Duration of Overall Response
The time from the start of cell infusion when CR or PR is first achieved to disease progression.
Time frame: Up to 12 months after CLL1/+CD33 CAR-T infusion
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MRD negative rate
The rate of MRD negative subjects was determined by flow cytometry.
Time frame: Up to 12 months after CLL1/+CD33 CAR-T infusion