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NCT06241456 | RECRUITING | Advanced Solid Tumor

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

Fate Therapeutics

Brief 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.

Condition or disease

Advanced Solid Tumor

Intervention/treatment

FT825

Fludarabine

Cyclophosphamide

Bendamustine

Docetaxel

Cisplatin

Cetuximab

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 351 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2024-01-05
Estimated Primary Completion Date : 2029-05-01
Estimated Study Completion Date : 2044-05-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
FT825/ONO-8250, an Off-the-Shelf, HER2 CAR-T, With or Without Monoclonal Antibodies in Advanced Solid Tumors

Location Details

NCT06241456

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

Banner MD Anderson Cancer Center

Gilbert, arizona, United States, 85234

RECRUITING

United States, California

University of California San Diego Moores Cancer Center

La Jolla, California, United States, 92037

RECRUITING

United States, Connecticut

Yale New Haven Hospital - Yale Cancer Center

New Haven, Connecticut, United States, 06510

RECRUITING

United States, Illinois

University of Chicago Medical Center

Chicago, Illinois, United States, 60637

RECRUITING

United States, road cancer

Karmanos Cancer Institute

Detroit, road cancer, United States, 48201

RECRUITING

United States, Minnesota

University of Minnesota Medical School

Minneapolis, Minnesota, United States, 55455

RECRUITING

United States, Missouri

Washington University School of Medicine

St Louis, Missouri, United States, 63110

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

RECRUITING

United States, Ohio

Oncology Hematology Care Clinial Trials

Cincinnati, Ohio, United States, 45242

RECRUITING

United States, Ohio

Ohio State University - Comprehensive Cancer Center

Columbus, Ohio, United States, 43210

RECRUITING

United States, Oklahola

OU Health Stephenson Cancer Center

Ololama City, Okholohan, United States, 73104

RECRUITING

United States, Pennsylvania

Thomas Jefferson University, Sidney Kimmel Cancer Center

Philadelphia, Pennsylvania, United States, 19107

RECRUITING

United States, Tennessee

Sarah Cannon Research Institute (SCRI) - Oncology Partners

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Texas

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030