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

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.

Conditions

Advanced Solid Tumor

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Advanced Solid Tumor
Intervention / Treatment

-

Contacts and Locations

New Haven

Yale New Haven Hospital - Yale Cancer Center, New Haven, Connecticut, United States, 06510

Detroit

Karmanos Cancer Institute, Detroit, Michigan, United States, 48201

Minneapolis

University of Minnesota Medical School, Minneapolis, Minnesota, United States, 55455

Saint Louis

Washington University School of Medicine, Saint Louis, Missouri, United States, 63110

New York

Icahn School of Medicine at Mount Sinai, New York, New York, United States, 10029

Cincinnati

Oncology Hematology Care Clinial Trials, Cincinnati, Ohio, United States, 45242

Columbus

Ohio State University - Comprehensive Cancer Center, Columbus, Ohio, United States, 43210

Oklahoma City

OU Health Stephenson Cancer Center, Oklahoma City, Oklahoma, United States, 73104

Philadelphia

Thomas Jefferson University, Philadelphia, Pennsylvania, United States, 19107

Nashville

Sarah Cannon Research Institute (SCRI) - Nashville, Nashville, Tennessee, United States, 37203

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Fate Therapeutics,

Study Director, STUDY_DIRECTOR, Fate Therapeutics

Study Record Dates

2044-05-01