Relapsed/Refractory Acute Myeloid Leukemia Clinical Trial
Official title:
Clinical Study of UTAA06 Injection in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia
Main research purpose： Evaluate the safety and tolerance of UTAA06 injection in the treatment of patients with relapsed/refractory acute myeloid leukemia. Secondary research purpose： Evaluate the expansion and persistence of gdT cells targeting B7-H3 chimeric antigen receptor after UTAA06 injection administration in vivo; Evaluate the efficacy of UTAA06 injection in the treatment of patients with relapsed/refractory acute myeloid leukemia; Evaluate the content of B7-H3 positive cells in the peripheral blood after administration of UTAA06 injection; Evaluate the immunogenicity of UTAA06 injection.
This study is a single arm, open label, dose increasing study to explore the characteristics of drug safety, tolerance and cell kinetics, and preliminarily observe the efficacy of the study drug in patients with relapsed/refractory B7-H3 positive acute myeloid leukemia, so as to explore the formal clinical appropriate dose. After the subjects who signed the informed consent form were screened by the inclusion/exclusion criteria, the qualified subjects will enter 1.0 in order of priority × 108，3.0 × 108 and 6.0 × 108 CAR gdT groups were administered once. The "3+3" design was adopted in the dose increasing study, that is, 3-6 subjects in each group completed a single dose. After the last subject in each dose group completed the dose limiting toxicity (DLT) assessment window 28 days after the single administration, the next dose group can be started after the Safety Monitoring Committee (SRC) agrees to enter the next dose group based on the evaluation of clinical safety data. When 1 DLT occurs in 3 subjects in a certain dose group, 3 subjects need to be added in the same dose group (up to 6 subjects in this dose group complete DLT evaluation): if the added 3 subjects have no DLT, the dose will continue to increase; If one of the three additional subjects has DLT, stop the dose increase; If more than one of the three additional subjects has DLT, stop the dose increase, and at the same time, reduce one dose to continue the DLT evaluation of the three subjects. The SRC can decide whether to increase or decrease the dose groups or adjust the dose of groups according to the pharmacokinetic results obtained during the study. ;
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