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NCT05066165

Phase 1/2a, Single Dose Study Investigating NTLA-5001 in Subjects With Acute Myeloid Leukemia

Study Summary

This study will be conducted to evaluate the safety, tolerability, cellular kinetics (CK), activity, and pharmacodynamics (PD) of NTLA-5001 in participants with Acute Myeloid Leukemia (AML).

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Interventions

Arm 1: NTLA-5001GENETIC
Autologous WT1-directed TCR T cells engineered ex vivo using CRISPR/Cas9 as intravenous infusion after pre-conditioning chemotherapy. Cyclophosphamide and Fludarabine will be administered on Day -5, -4, and -3 as intravenous infusion.
Arm 2: NTLA-5001GENETIC
Autologous WT1-directed TCR T cells engineered ex vivo using CRISPR/Cas9 as intravenous infusion after pre-conditioning chemotherapy. Cyclophosphamide and Fludarabine will be administered on Day -5, -4, and -3 as intravenous infusion.

Study Locations

FacilityCityStateCountry
Research Site 2Los AngelesCaliforniaUnited States
Research Site 5TampaFloridaUnited States
Research Site 1BostonMassachusettsUnited States
Research Site 6PortlandOregonUnited States
Research Site 3HoustonTexasUnited States
Research Site 4MilwaukeeWisconsinUnited States
Research Site 10LeedsUnited Kingdom
Research Site 8LondonUnited Kingdom
Research Site 9LondonUnited Kingdom
Research Site 7ManchesterUnited Kingdom

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026