Off-the-shelf CAR-T therapy for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1 study evaluates the safety, tolerability, and antitumor activity of FT825, an off-the-shelf CAR-T therapy targeting HER2, in patients with advanced solid tumors. Participants will receive FT825 with or without monoclonal antibodies following chemotherapy. The study includes a dose-escalation phase to determine the optimal dosage, followed by an expansion phase to assess the therapy's effectiveness in specific cancer types. The goal is to provide a new treatment option for patients with HER2-positive or other advanced solid tumors.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where it's running

• Banner MD Anderson Cancer Center
  Gilbert, Arizona, United States Recruiting
• University of California San Diego Moores Cancer Center
  La Jolla, California, United States Recruiting
• Yale New Haven Hospital - Yale Cancer Center
  New Haven, Connecticut, United States Recruiting
• University of Chicago Medical Center
  Chicago, Illinois, United States Recruiting
• Karmanos Cancer Institute
  Detroit, Michigan, United States Recruiting
• University of Minnesota Medical School
  Minneapolis, Minnesota, United States Recruiting

Study contacts

• Study coordinator: Fate Trial Disclosure
• Email: FateTrialDisclosure@fatetherapeutics.com
• Phone: 858-875-1800

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.