Off-the-shelf CAR-T therapy for advanced solid tumors
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
This study is testing a new off-the-shelf CAR-T therapy called FT825 to see if it can help people with advanced solid tumors, especially those with HER2-positive cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 351 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fate Therapeutics Industry-sponsored |
| Drugs / interventions | chimeric antigen receptor, immunotherapy, chemotherapy |
| Locations | 14 sites (Gilbert, Arizona and 13 other locations) |
| Trial ID | NCT06241456 on ClinicalTrials.gov |
What this trial studies
This phase 1 study evaluates the safety, tolerability, and antitumor activity of FT825, an off-the-shelf CAR-T therapy targeting HER2, in patients with advanced solid tumors. Participants will receive FT825 with or without monoclonal antibodies following chemotherapy. The study includes a dose-escalation phase to determine the optimal dosage, followed by an expansion phase to assess the therapy's effectiveness in specific cancer types. The goal is to provide a new treatment option for patients with HER2-positive or other advanced solid tumors.
Who should consider this trial
Good fit: Ideal candidates include individuals with HER2-positive advanced solid tumors who have not responded to curative therapies.
Not a fit: Patients with active central nervous system involvement by malignancy or significant organ dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could offer a new treatment option for patients with advanced solid tumors that are currently difficult to treat.
How similar studies have performed: Other studies using CAR-T therapies have shown promising results, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Gilbert, Arizona and 13 other locations
- Banner MD Anderson Cancer Center — Gilbert, Arizona, United States (Recruiting)
- University of California San Diego Moores Cancer Center — La Jolla, California, United States (Recruiting)
- Yale New Haven Hospital - Yale Cancer Center — New Haven, Connecticut, United States (Recruiting)
- University of Chicago Medical Center — Chicago, Illinois, United States (Recruiting)
- Karmanos Cancer Institute — Detroit, Michigan, United States (Recruiting)
- University of Minnesota Medical School — Minneapolis, Minnesota, United States (Recruiting)
- Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- Oncology Hematology Care Clinial Trials — Cincinnati, Ohio, United States (Recruiting)
- Ohio State University - Comprehensive Cancer Center — Columbus, Ohio, United States (Recruiting)
- OU Health Stephenson Cancer Center — Oklahoma City, Oklahoma, United States (Recruiting)
- Thomas Jefferson University, Sidney Kimmel Cancer Center — Philadelphia, Pennsylvania, United States (Recruiting)
- Sarah Cannon Research Institute (SCRI) - Oncology Partners — Nashville, Tennessee, United States (Recruiting)
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Fate Trial Disclosure
- Email: FateTrialDisclosure@fatetherapeutics.com
- Phone: 858-875-1800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.