NCT07216105

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

Study 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.

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Interventions

FT836DRUG
FT836 drug product is administered as an intravenous infusion on multiple days schedule at treatment cycle.
PaclitaxelDRUG
IV infusion ; 80 mg/m2 QW; Days -21, -14, and -7
CetuximabDRUG
Cetuximab administration will begin on Day -4 at the recommended initial dose of 400 mg/m2 as a 120-minute IV infusion
TrastuzumabDRUG
trastuzumab administration will begin on Day -4 at an initial dose of 4 mg/kg as a 90-minute IV infusion.

Study Locations

FacilityCityStateCountry
University of Southern CaliforniaLa JollaCaliforniaUnited States
UC San Diego Moores Cancer CenterLa JollaCaliforniaUnited States
University of Minnesota Masonic Cancer CenterMinneapolisMinnesotaUnited States
Thomas Jefferson University, Sidney Kimmel Cancer CenterPhiladelphiaPennsylvaniaUnited States
M. D. Anderson Cancer CenterHoustonTexasUnited States

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026