RecruitingPhase 1NCT07216105

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


Sponsor

Fate Therapeutics

Enrollment

113 participants

Start Date

Nov 4, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new cell therapy called FT836, given alone or in combination with chemotherapy and/or antibody treatments, in people with advanced solid tumors that have progressed despite prior treatments. FT836 is a type of engineered immune cell designed to attack cancer. **You may be eligible if...** - You have advanced solid tumor cancer that cannot be cured and has progressed after at least one prior systemic treatment - Your cancer is measurable on scans - You are reasonably functional (ECOG 0 or 1) - You are willing to undergo biopsies during the study - Your blood counts, kidney, liver, and organ function are adequate **You may NOT be eligible if...** - You have significant untreated heart disease (heart failure, recent heart attack, arrhythmia, or low ejection fraction) - You have active brain metastases - You have a non-cancer brain or nervous system condition (like stroke or epilepsy) - You have received cancer treatments within 2 weeks or 5 drug half-lives before starting the study - You require long-term immune-suppressing steroids - You have had a prior severe immune-related reaction to cancer immunotherapy - You have significant peripheral neuropathy (nerve damage affecting daily function) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFT836

FT836 drug product is administered as an intravenous infusion on multiple days schedule at treatment cycle.

DRUGPaclitaxel

IV infusion ; 80 mg/m2 QW; Days -21, -14, and -7

DRUGCetuximab

Cetuximab administration will begin on Day -4 at the recommended initial dose of 400 mg/m2 as a 120-minute IV infusion

DRUGTrastuzumab

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

View Full Details on ClinicalTrials.gov

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NCT07216105


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