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

NCT06241456
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
351
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Lead sponsor
Fate Therapeutics
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Start date
2024-01-05
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Number of sites
14
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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.
clinicaltrials.gov
Short title
FT825/ONO-8250, an Off-the-Shelf, HER2 CAR-T, With or Without Monoclonal Antibodies in Advanced Solid Tumors
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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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2044-05-01
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First posted
2024-02-05
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Registry last updated
2025-12-09
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Primary completion date
2029-05-01
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Start date
2024-01-05
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Participants
351
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Participant count basis
Estimated
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Planned participants
351
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Protocol amendments
2
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Number of sites
14
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Fate Therapeutics
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06241456
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ClinicalTrials.gov ID
NCT06241456
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Registry record
Open registry record
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Allocation
Not randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Number of participants with dose limiting toxicities (DLTs)

    Timeframe: Up to approximately 29 days

    The number of participants with DLTs will be reported.

  2. Number of participants with treatment-emergent adverse events (TEAEs)

    Timeframe: Up to approximately 2 years

    The number of participants with TEAEs will be reported.

  3. Severity of AEs

    Timeframe: Up to approximately 2 years

    Severity of AEs will be determined according to appropriate rating scales for the type of event reported.

  1. Investigator-Assessed Overall Response Rate (ORR)

    Timeframe: Up to approximately 2 years

    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).

  2. Investigator-Assessed Duration of Response (DOR)

    Timeframe: Up to approximately 2 years

    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.

  3. Progression-Free Survival (PFS)

    Timeframe: Up to approximately 2 years

    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.

  4. Overall Survival (OS)

    Timeframe: Up to approximately 2 years

    OS defined as the time from first dose of study intervention to death from any cause.

  5. Plasma Concentration of FT825

    Timeframe: At designated time points up to approximately 56 days

    The plasma concentration of FT825 will be determined.

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • 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
Sources for eligibility
clinicaltrials.gov

  • Banner MD Anderson Cancer CenterGilbert, United StatesRecruiting
  • University of California San Diego Moores Cancer CenterLa Jolla, United StatesRecruiting
  • Yale New Haven Hospital - Yale Cancer CenterNew Haven, United StatesRecruiting
  • University of Chicago Medical CenterChicago, United StatesRecruiting
  • Karmanos Cancer InstituteDetroit, United StatesRecruiting
  • University of Minnesota Medical SchoolMinneapolis, United StatesRecruiting
  • Washington University School of MedicineSt Louis, United StatesRecruiting
  • Memorial Sloan Kettering Cancer CenterNew York, United StatesRecruiting
  • Oncology Hematology Care Clinial TrialsCincinnati, United StatesRecruiting
  • Ohio State University - Comprehensive Cancer CenterColumbus, United StatesRecruiting
  • OU Health Stephenson Cancer CenterOklahoma City, United StatesRecruiting
  • Thomas Jefferson University, Sidney Kimmel Cancer CenterPhiladelphia, United StatesRecruiting
  • Sarah Cannon Research Institute (SCRI) - Oncology PartnersNashville, United StatesRecruiting
  • The University of Texas MD Anderson Cancer CenterHouston, United StatesRecruiting
Sources for sites
clinicaltrials.gov

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