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NCT05432401

Clinical Study of TAA05 Injection in the Treatment of Adult Patients With FLT3-positive Relapsed/Refractory Acute Myeloid Leukemia

Study Summary

This is a single arm , open-label, dose-escalation clinical study with the primary objective of evaluating the safety and tolerability of TAA05 injection in adult subjects with FLT3-positive relapsed/refractory acute myeloid leukemia. The secondary objectives are as follows: to evaluate the in vivo expansion and persistence of FLT3-targeted chimeric antigen receptor T (CAR-T) cells after injection of TAA05;to evaluate the proportion of FLT3-positive cells in peripheral blood after injection of TAA05;to preliminarily evaluate the efficacy of TAA05 injection in adult subjects with FLT3-positive relapsed/refractory acute myeloid leukemia;to evaluate the immunogenicity of TAA05 injection;and to explore the applicable dose in the formal clinical phase.

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Interventions

T cell injection targeting FLT3 chimeric antigen receptorBIOLOGICAL
The subjects, who sign the informed consent forms and been screened by inclusion/exclusion criteria, will be assigned into 1.0 × 10\^8, 2.0 × 10\^8 and 4.0 × 10\^8 CAR-T groups in order of sequence. And the subjects will be administered once.

Study Locations

FacilityCityStateCountry
Union Hospital, affiliated with TongJi Medical College, HuaZhong University of Science and TechnologyWuhanHubeiChina

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026