Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
study ends around

Description

Summary

This is a phase 1 study designed to evaluate the safety, tolerability, and antitumor activity of FT825 (also known as ONO-8250) with or without monoclonal antibody therapy following chemotherapy in participants with advanced human epidermal growth factor receptor 2 (HER2)-positive or other advanced solid tumors. The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT825 in indication-specific cohorts.

Official Title

A Phase 1 Study of FT825/ONO-8250, an Off-the-Shelf CAR T-Cell Therapy, With or Without Monoclonal Antibodies, in HER2-Positive or Other Advanced Solid Tumors

Keywords

Advanced Solid Tumor, fludarabine, fludarabine phosphate, Cyclophosphamide, Bendamustine Hydrochloride, Docetaxel, Cisplatin, Cetuximab, Bendamustine, FT825, FT825 + Cetuximab

Eligibility

You can join if…

Open to people ages 18 years and up

  • Histopathological or cytologically confirmed locally advanced or metastatic cancer that meets protocol-defined criteria
  • Disease that is not amenable to curative therapy, with prior therapies defined by specific tumor types
  • Contraceptive use by women and men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
  • Presence of measurable disease by RECIST, v1.1 assessed within 28 days prior to start of first study intervention
  • Anticipated life expectancy of at least 3 months

You CAN'T join if...

  • Females who are pregnant or breastfeeding
  • Evidence of inadequate organ function
  • Clinically significant cardiovascular disease
  • Known active central nervous system (CNS) involvement by malignancy
  • Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease or receipt of medications for these conditions within 2 years prior to study enrollment
  • Active bacterial, fungal, or viral infections
  • Prior receipt of chimeric antigen receptor (CAR) T-cell therapy, other cellular therapy, or a FATE investigational human induced pluripotent stem cell (iPSC) product
  • History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out based on imaging at screening
  • Any history of Grade ≥3 immune-related AE or Grade ≥2 eye toxicity attributed to prior cancer immunotherapy, other than endocrinopathy managed with replacement therapy or asymptomatic elevation of serum amylase or lipase
  • Active or history of autoimmune disease or immune deficiency
  • Receipt of an allograft organ transplant

Locations

  • University of California San Diego Moores Cancer Center accepting new patients
    La Jolla 5363943 California 5332921 92037 United States
  • Banner MD Anderson Cancer Center accepting new patients
    Gilbert 5295903 Arizona 5551752 85234 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Fate Therapeutics
ID
NCT06241456
Phase
Phase 1 Solid Tumor Research Study
Study Type
Interventional
Participants
Expecting 351 study participants
Last Updated