drugset / Trial / NCT07668557

Anti-CD33-CLL1 CAR-T Cells (ICG415) for the Treatment of Relapsed/Refractory Acute Myeloid Leukemia

NCT07668557 ↗

Phase 1 Recruiting 18 enrolled iCell Gene Therapeutics
NaSequentialOpen-labelTreatment

Summary

This single-arm, open-label phase I trial evaluates the safety and tolerability of ICG415, autologous CAR-T cells targeting CD33 and CLL1, in patients with relapsed or refractory acute myeloid leukemia (AML). Subjects receive lymphodepleting chemotherapy followed by autologous CAR-T infusion. The primary goal is to assess safety and preliminary anti-leukemic efficacy in patients failing standard AML therapies.

Timeline

Start
2026-06-10
Primary completion
2028-07-04
Completion
2029-07-04

Drugs

EvaluationDrugModalityDoseRoute
Subject ICG415 Cell therapy — —
Background Cyclophosphamide Other / unclassified — —
Background Fludarabine Small molecule — —