RE: NCT0678653322 Jan 2025 23:00
Study Overview
Brief Summary
This is a phase 1 dose escalation study to determine the safety of anti-FLT3 CAR-T in subjects with R/R AML. The primary objective is to assess safety. Up to 18 evaluable subjects will be enrolled. Evaluable subjects are defined as those who have received an infusion of HG-CT-1.
Primary clinical objectives:
i. Determine the safety of HG-CT-1 based on the proportion of subjects infused with HG-CT-1 who experience a dose limiting toxicity (DLT).
Secondary clinical objectives:
i. Estimate the efficacy of HG-CT-1 according to standard clinical response criteria for AML.
ii. Estimate overall survival of evaluable subjects. iii. Estimate progression-free survival of evaluable subjects. iv. Estimate duration of response in evaluable subjects who achieve a response.
Secondary scientific objectives:
i. Describe the persistence and trafficking of HG-CT-1. ii. Describe HG-CT-1 bioactivity and its predictors.