Clinical trial NCT06241456: FT825/ONO-8250, an Off-the-Shelf, HER2 CAR-T, with or Without Monoclonal Antibodies in Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: Fate Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-02-05
Enrollment: 351
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of participants with dose limiting toxicities (DLTs)
timeFrame: Up to approximately 29 days
measure: Number of participants with treatment-emergent adverse events (TEAEs)
timeFrame: Up to approximately 2 years
measure: Severity of AEs
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Investigator-Assessed Overall Response Rate (ORR)
timeFrame: Up to approximately 2 years
measure: Investigator-Assessed Duration of Response (DOR)
timeFrame: Up to approximately 2 years
measure: Progression-Free Survival (PFS)
timeFrame: Up to approximately 2 years
measure: Overall Survival (OS)
timeFrame: Up to approximately 2 years
measure: Plasma Concentration of FT825
timeFrame: At designated time points up to approximately 56 days
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center
state: Arizona
city: La Jolla
country: United States
facility: University of California San Diego Moores Cancer Center
state: California
city: New Haven
country: United States
facility: Yale New Haven Hospital - Yale Cancer Center
state: Connecticut
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Medical School
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Cincinnati
country: United States
facility: Oncology Hematology Care Clinial Trials
state: Ohio
city: Columbus
country: United States
facility: Ohio State University - Comprehensive Cancer Center
state: Ohio
city: Oklahoma City
country: United States
facility: OU Health Stephenson Cancer Center
state: Oklahoma
city: Philadelphia
country: United States
facility: Thomas Jefferson University, Sidney Kimmel Cancer Center
state: Pennsylvania
city: Nashville
country: United States
facility: Sarah Cannon Research Institute (SCRI) - Oncology Partners
state: Tennessee
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Fate Therapeutics
name: Study Director
role: STUDY_DIRECTOR
References: