Actively Recruiting
FT825/ONO-8250, an Off-the-Shelf, HER2 CAR-T, With or Without Monoclonal Antibodies in Advanced Solid Tumors
Led by Fate Therapeutics · Updated on 2025-12-09
351
Participants Needed
14
Research Sites
1060 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
FT825/ONO-8250, an Off-the-Shelf, HER2 CAR-T, With or Without Monoclonal Antibodies in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 follow local regulations for clinical study participants
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Presence of measurable disease by RECIST, v1.1 within 28 days before first study intervention
- Anticipated life expectancy of at least 3 months
You will not qualify if you...
- 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 or treatment for CNS conditions within 2 years prior to enrollment
- Active bacterial, fungal, or viral infections
- Prior receipt of CAR T-cell therapy, other cellular therapy, or FATE investigational iPSC product
- History or current interstitial lung disease (ILD)/pneumonitis requiring steroids or suspected ILD/pneumonitis not ruled out by imaging
- History of Grade 3 or higher immune-related adverse event or Grade 2 or higher eye toxicity from prior cancer immunotherapy, except managed endocrinopathy or asymptomatic enzyme elevation
- Active or history of autoimmune disease or immune deficiency
- Receipt of an allograft organ transplant
AI-Screening
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Trial Site Locations
Total: 14 locations
1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Actively Recruiting
2
University of California San Diego Moores Cancer Center
La Jolla, California, United States, 92037
Actively Recruiting
3
Yale New Haven Hospital - Yale Cancer Center
New Haven, Connecticut, United States, 06510
Actively Recruiting
4
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
5
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
6
University of Minnesota Medical School
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
7
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
8
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
9
Oncology Hematology Care Clinial Trials
Cincinnati, Ohio, United States, 45242
Actively Recruiting
10
Ohio State University - Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
11
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
12
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
13
Sarah Cannon Research Institute (SCRI) - Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
14
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
F
Fate Trial Disclosure
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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