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

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

Trial Details

NCT ID
NCT06786533
Phase
PHASE1
Sponsor
Hemogenyx Pharmaceuticals LLC
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Anti-FLT3 CAR-T cells
Locations (sample)
  • Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

  • 18 years of age or older at enrollment. Patients ≥12 and \<18 12 to 17 years of age weighing ≥ 35 kg at enrollment may be included once safety eval…
  • Subjects with AML unlikely to be cured with currently available therapies. Specifically, the following groups are eligible:
  • Refractory AML: i.e., newly diagnosed AML that after two cycles of intensive chemotherapy has not achieved a complete remission or morphologic leuk…
  • Patients with FLT3 ITD must also have failed treatment with a FLT3 inhibitor and patients with IDH1 or IDH2 mutations must have failed treatment co…

For full eligibility, visit ClinicalTrials.gov.

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