drugset / Trial / NCT05432401

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

NCT05432401 ↗

Phase 0 Unknown 18 enrolled PersonGen BioTherapeutics (Suzhou) Co., Ltd.
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2022-06-09
Primary completion
2023-06-09
Completion
2025-06-09

Drugs

EvaluationDrugModalityDoseRoute
Subject TAA05 Unknown 1e+08 cells —
Subject TAA05 Unknown 2e+08 cells —
Subject TAA05 Unknown 4e+08 cells —