NCT07216105

FT836 With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid Tumors

A Phase 1, Open-Label Study of FT836, an Off-the-Shelf CAR T-Cell Therapy, With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 113 (estimated)
• Sponsor: Fate Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1 study of FT836 administered in participants with advanced solid tumors. The primary objectives of the study are to evaluate the safety and tolerability of FT836 with or without paclitaxel and/or trastuzumab or cetuximab, and to determine the recommended phase 2 dose (RP2D) of FT836 in combination with trastuzumab or cetuximab; each objective will be assessed with or without paclitaxel chemotherapy.

Conditions

• Non-Small Cell Lung Cancer
• Colorectal Cancer
• Breast Cancer
• Ovarian Cancer
• Endometrial Carcinoma
• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	FT836	FT836 drug product is administered as an intravenous infusion on multiple days schedule at treatment cycle.
DRUG	Paclitaxel	IV infusion ; 80 mg/m2 QW; Days -21, -14, and -7
DRUG	Cetuximab	Cetuximab administration will begin on Day -4 at the recommended initial dose of 400 mg/m2 as a 120-minute IV infusion
DRUG	Trastuzumab	trastuzumab administration will begin on Day -4 at an initial dose of 4 mg/kg as a 90-minute IV infusion.

Timeline

• Start date: 2025-11-04
• Primary completion: 2028-01-01
• Completion: 2030-01-01
• First posted: 2025-10-14
• Last updated: 2026-04-07

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study