drugset
drugset / Trial / NCT04714372

FT538 in Combination With Daratumumab in AML Acute Myeloid Leukemia

NCT04714372 ↗

Phase 1 Completed 9 enrolled Masonic Cancer Center, University of Minnesota
Non-randomizedSequentialOpen-labelTreatment

Summary

This Phase I open-label dose escalation study is conducted in two stages with a primary endpoint to identify the maximum tolerated dose (MTD) of FT538 when administered with daratumumab in patients 12 years and older with advanced acute myeloid leukemia (AML) and related myeloid diseases.

Timeline

Start
2021-11-03
Primary completion
2024-01-09
Completion
2024-10-15

Drugs

EvaluationDrugModalityDoseRoute
Subject FT538 Cell therapy 5e+07 cells Intravenous
Subject FT538 Cell therapy 1e+08 cells Intravenous
Subject FT538 Cell therapy 3e+08 cells Intravenous
Subject FT538 Cell therapy 1e+09 cells Intravenous
Subject FT538 Cell therapy 1.5e+09 cells Intravenous
Background Cyclophosphamide Other / unclassified 300 mg/m2 Intravenous
Background Daratumumab Monoclonal antibody 1800 mg Subcutaneous
Background Fludarabine Small molecule 25 mg/m2 Intravenous

Indications

acute myeloid leukemia monocytic leukemia