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RECRUITING
NCT07216105
PHASE1

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

Sponsor: Fate Therapeutics

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

113

Start Date

2025-11-04

Completion Date

2030-01

Last Updated

2026-04-07

Healthy Volunteers

No

Interventions

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.

Locations (5)

University of Southern California

La Jolla, California, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

University of Minnesota Masonic Cancer Center

Minneapolis, Minnesota, United States

Thomas Jefferson University, Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, United States

M. D. Anderson Cancer Center

Houston, Texas, United States