NCT04614636

FT538 in Subjects With Advanced Hematologic Malignancies

A Phase I, Open-Label, Multicenter Study of FT538 as Monotherapy in Relapsed/Refractory Acute Myelogenous Leukemia and in Combination With Monoclonal Antibodies in Relapsed/Refractory Multiple Myeloma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Fate Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I dose-finding study of FT538 as monotherapy in acute myeloid leukemia (AML) and in combination with monoclonal antibodies in multiple myeloma (MM). The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.

Conditions

• Acute Myeloid Leukemia
• AML, Adult
• Multiple Myeloma
• Myeloma

Interventions

Type	Name	Description
DRUG	FT538	Experimental Interventional Therapy, Allogeneic Cell Therapy NK Cell
DRUG	Cyclophosphamide	Lympho-conditioning Agent
DRUG	Fludarabine	Lympho-conditioning Agent
DRUG	Daratumumab	Monoclonal Antibody, CD38, Anti-CD38
DRUG	Elotuzumab	Monoclonal Antibody

Timeline

• Start date: 2020-10-17
• Primary completion: 2023-07-13
• Completion: 2023-08-08
• First posted: 2020-11-04
• Last updated: 2023-09-21

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study