NCT05069935

FT538 in Combination With Monoclonal Antibodies in Advanced Solid Tumors

A Phase I, Open-Label, Multicenter Study of FT538 in Combination With Monoclonal Antibodies in Subjects With Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Fate Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1 dose-finding study of FT538 in combination with monoclonal antibodies.

Detailed description

This is a Phase 1 dose-finding study of FT538 given in combination with a monoclonal antibody following lymphodepletion in subjects with advanced solid tumors. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
DRUG	FT538	FT538 is an allogeneic natural killer (NK)-cell immunotherapy
DRUG	Cyclophosphamide	Lympho-conditioning agent
DRUG	Fludarabine	Lympho-conditioning agent
COMBINATION_PRODUCT	Monoclonal antibody - Dose Escalation	either avelumab, trastuzumab or cetuximab
COMBINATION_PRODUCT	Monoclonal antibody - Dose Expansion	either avelumab, atezolizumab, nivolumab, pembrolizumab, trastuzumab or cetuximab

Timeline

• Start date: 2021-10-15
• Primary completion: 2023-08-11
• Completion: 2023-08-11
• First posted: 2021-10-06
• Last updated: 2023-09-21

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study