Clinical Trial

Disease: Solid Tumors, (NCT06241456)

Disease info:

A solid tumour is an abnormal mass of tissue that usually does not contain cysts or liquid areas. Solid tumours may be benign (not cancer), or malignant (cancer). Solid tumour types are named according to the type of cell they originate from. Examples of solid tumors are sarcomas, carcinomas, and lymphomas. Leukaemias (cancers of the blood) generally do not form solid tumours. 

This trial is specifically targeting patients with melanoma, head and neck squamous cell carcinoma (HNSCC), and non-small cell lung cancer (NSCLC).

The word tumour does not always imply cancer. In discussing tumours that are malignant (cancerous), however, the term solid tumour is used to distinguish between a localised mass of tissue and leukaemia.

Frequency:
More than 1.9 million new cancer cases are expected to be diagnosed in the US in 2023.
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
Who:

Contact

Phone: 866-875-1800

Email: FateTrialDisclosure@fatetherapeutics.com

Sponsor:

Fate Therapeutics

Partners:
Locations:

United States, Arizona

Banner MD Anderson Cancer Center, Gilbert, Arizona, United States, 85234



United States, California

University of California San Diego Moores Cancer Center, La Jolla, California, United States, 92037

 

United States, Connecticut

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

 

United States, Illinois

University of Chicago Medical Center, Chicago, Illinois, United States, 60637

 

United States, Michigan

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

 

United States, Minnesota 

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

 

United States, Missouri

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

 

United States, New York

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

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

 

United States, Ohio

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

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

 

United States, Oklahoma

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

 

United States, Pennsylvania

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

 

United States, Tennessee

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

 

United States, Texas

The University of Texas MD Anderson Cancer Center, Houston, Texas, United States, 77030

Study start:
Jan. 5, 2024
Enrollment:
351 participants
Gene editing method:
CRISPR-Cas
Type of edit:
Seven functional edits that are collectively expected to overcome the unique challenges associated with treating solid tumours. These include expression of a CXCR2 receptor to promote CAR T-cell trafficking to the site of the tumour, as well as chimeric TGFβ to redirect immunosuppressive signals in the tumour microenvironment.
Gene:
TRAC, IL7RF, CD16a, CXCR2, TGF-B, CD38, HER2. For further details, see: https://www.fatetherapeutics.com/pipeline/immuno-oncology-candidates/ft825/
Delivery method:
- Ex-vivo
Trial link:
https://clinicaltrials.gov/study/NCT06241456?spons=Fate%20Therapeutics&page=1&rank=2#study-overview
Safety updates:

(09-11-2024) Fate Therapeutics Highlights Cancer-selective, HER2-Targeting Profile of FT825 / ONO-8250 CAR T-cell Product Candidate for Treatment of Advanced Solid Tumors at 2024 SITC Annual Meeting

(10-01-2024) Fate Therapeutics Initiates Phase 1 Trial in HER2-Positive Advanced Solid Tumours

Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting

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.

Last updated: Jan. 13, 2025
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