NCT05182073

FT576 in Subjects With Multiple Myeloma

A Phase I Study of FT576 as Monotherapy and in Combination With Daratumumab in Subjects With Relapsed/Refractory Multiple Myeloma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Fate Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I dose-finding study of FT576 as monotherapy and in combination with the monoclonal antibody daratumumab in multiple myeloma (MM). The study will consist of a dose-escalation stage and an expansion stage.

Conditions

• Multiple Myeloma
• Myeloma

Interventions

Type	Name	Description
DRUG	FT576 (Allogenic CAR NK cells with BCMA expression)	Experimental Interventional Therapy: FT576 comprises allogeneic natural killer (NK) cells, derived from a clonal, CD38-knockout, human-induced pluripotent stem cell line (iPSC) that expresses anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR), high-affinity, non-cleavable CD16 (hnCD16), and IL-15/IL-15 receptor fusion protein (IL-15RF).
DRUG	Cyclophosphamide	Conditioning Agent
DRUG	Fludarabine	Conditioning Agent
DRUG	Daratumumab	Anti-CD38 Monoclonal Antibody
DRUG	Bendamustine	Conditioning Agent

Timeline

• Start date: 2021-11-10
• Primary completion: 2024-09-20
• Completion: 2024-10-18
• First posted: 2022-01-10
• Last updated: 2025-12-12

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study