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

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

Age range

18+ years

Sex

All

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)