RECRUITING

FT825/ONO-8250, an Off-the-Shelf, HER2 CAR-T, with or Without Monoclonal Antibodies in Advanced Solid Tumors

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2024-01-05

Study Completion:2044-05-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06241456

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Fate Trial Disclosure

CONTACT

866-875-1800

FateTrialDisclosure@fatetherapeutics.com

Principal Investigator

Study Director

STUDY_DIRECTOR

Fate Therapeutics

Study Locations (Sites)

Yale New Haven Hospital - Yale Cancer Center

New Haven, Connecticut, 06510

United States

Karmanos Cancer Institute

Detroit, Michigan, 48201

United States

University of Minnesota Medical School

Minneapolis, Minnesota, 55455

United States

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

United States

Oncology Hematology Care Clinial Trials

Cincinnati, Ohio, 45242

United States

Ohio State University - Comprehensive Cancer Center

Columbus, Ohio, 43210

United States

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104

United States

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107

United States

Sarah Cannon Research Institute (SCRI) - Nashville

Nashville, Tennessee, 37203

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Fate Therapeutics

Study Director, STUDY_DIRECTOR, Fate Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-05

Study Completion Date2044-05-01

Study Record Updates

Study Start Date2024-01-05

Study Completion Date2044-05-01

Terms related to this study

Additional Relevant MeSH Terms

Advanced Solid Tumor