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

Advanced Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06241456
• Other study ID #: FT825-101
• Status: Recruiting
• Phase: Phase 1
• Start date: January 5, 2024
• Est. completion date: May 1, 2044

Study information

• Verified date: June 2024
• Source: Fate Therapeutics
• Contact: Fate Trial Disclosure
• Phone: 866-875-1800
• Email: FateTrialDisclosure[@]fatetherapeutics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 351
• Est. completion date: May 1, 2044
• Est. primary completion date: May 1, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• FT825
FT825 will be administered as an intravenous (IV) infusion at planned dose levels.
• Fludarabine
Fludarabine will be administered as an IV infusion at planned dose levels.
• Cyclophosphamide
Cyclophosphamide will be administered as an IV infusion at planned dose levels.
• Bendamustine
Bendamustine will be administered as an IV infusion at planned dose levels.
• Docetaxel
Docetaxel will be administered as an IV infusion at planned dose levels.
• Cisplatin
Cisplatin will be administered as an IV infusion at planned dose levels.
• Cetuximab
Cetuximab will be administered as an IV infusion at planned dose levels.

Locations

Country	Name	City	State
United States	Oncology Hematology Care Clinial Trials	Cincinnati	Ohio
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	The University of Texas MD Anderson Cancer Center	Houston	Texas
United States	University of Minnesota Medical School	Minneapolis	Minnesota
United States	Sarah Cannon Research Institute (SCRI) - Nashville	Nashville	Tennessee
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Fate Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with dose limiting toxicities (DLTs)	The number of participants with DLTs will be reported.	Up to approximately 29 days
Primary	Number of participants with treatment-emergent adverse events (TEAEs)	The number of participants with TEAEs will be reported.	Up to approximately 2 years
Primary	Severity of AEs	Severity of AEs will be determined according to appropriate rating scales for the type of event reported.	Up to approximately 2 years
Secondary	Investigator-Assessed Overall Response Rate (ORR)	ORR is the proportion of participants who achieve partial response (PR) or complete response (CR) per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST, v.1.1).	Up to approximately 2 years
Secondary	Investigator-Assessed Duration of Response (DOR)	DOR is the duration from the first occurrence of a documented objective response of either PR or CR until the time of disease progression, or death from any cause, whichever occurs first, per RECIST, v.1.1.	Up to approximately 2 years
Secondary	Progression-Free Survival (PFS)	PFS is the time from first dose of study intervention to disease progression, or to the day of death for any reason, whichever occurs first, per RECIST, v.1.1.	Up to approximately 2 years
Secondary	Overall Survival (OS)	OS defined as the time from first dose of study intervention to death from any cause.	Up to approximately 2 years
Secondary	Plasma Concentration of FT825	The plasma concentration of FT825 will be determined.	At designated time points up to approximately 56 days