NCT06786533

Clinical Study of Anti-FLT3 CAR-T Cells for the Treatment of Relapsed/Refractory AML

Phase 1 Study of Anti-FLT3 Chimeric Antigen Receptor-redirected T Cells in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Hemogenyx Pharmaceuticals LLC · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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 adult and 18 evaluable pediatric 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.

Conditions

• Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)

Interventions

Type	Name	Description
DRUG	Anti-FLT3 CAR-T cells	Anti-FLT3 CAR-T cells is administered by intravenous infusion following standard lymphodepleting chemotherapy consisting of fludarabine and cyclophosphamide.

Timeline

• Start date: 2025-01-23
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2025-01-22
• Last updated: 2025-08-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study