NCT03841110

FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors

FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors (Phase 1)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Fate Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

FT500 is an off-the-shelf, iPSC-derived NK cell product that can bridge innate and adaptive immunity, and has the potential to overcome multiple mechanisms of immune checkpoint inhibitor (ICI) resistance. The preclinical data provide compelling evidence supporting the clinical investigation of FT500 as monotherapy and in combination with ICI in participants with advanced solid tumors.

Conditions

• Advanced Solid Tumors
• Lymphoma
• Gastric Cancer
• Colorectal Cancer
• Head and Neck Cancer
• Squamous Cell Carcinoma
• EGFR Positive Solid Tumor
• HER2-positive Breast Cancer
• Hepatocellular Carcinoma
• Small Cell Lung Cancer
• Renal Cell Carcinoma
• Pancreas Cancer
• Melanoma
• NSCLC
• Urothelial Carcinoma
• Cervical Cancer
• Microsatellite Instability
• Merkel Cell Carcinoma

Interventions

Type	Name	Description
DRUG	FT500	FT500 is an allogeneic, iPSC-derived Natural Killer (NK) cell cancer immunotherapy
DRUG	Nivolumab	Immune Checkpoint Inhibitor
DRUG	Pembrolizumab	Immune Checkpoint Inhibitor
DRUG	Atezolizumab	Immune Checkpoint Inhibitor
DRUG	Cyclophosphamide	Lympho-conditioning agent
DRUG	Fludarabine	Lympho-conditioning agent
DRUG	IL-2	Biologic response modifier

Timeline

• Start date: 2019-02-15
• Primary completion: 2022-11-15
• Completion: 2022-11-15
• First posted: 2019-02-15
• Last updated: 2023-05-01

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study