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

February 5, 2024 updated by: Fate Therapeutics

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

351

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota Medical School
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon Research Institute (SCRI) - Nashville
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas MD Anderson Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Regimen A: FT825
Participants with advanced HER2-expressing solid tumors receive FT825 following chemotherapy in Cycle 1 (each cycle is approximately 61 days). Based on the safety, tolerability, and radiographically confirmed clinical benefit to treatment in Cycle 1, participants may be considered for an additional treatment cycle (Cycle 2 retreatment).
Drug: FT825
FT825 will be administered as an intravenous (IV) infusion at planned dose levels.
Other Names:
  • ONO-8250
Drug: Fludarabine
Fludarabine will be administered as an IV infusion at planned dose levels.
Other Names:
  • FLUDARA
Drug: Cyclophosphamide
Cyclophosphamide will be administered as an IV infusion at planned dose levels.
Drug: Bendamustine
Bendamustine will be administered as an IV infusion at planned dose levels.
Drug: Docetaxel
Docetaxel will be administered as an IV infusion at planned dose levels.
Drug: Cisplatin
Cisplatin will be administered as an IV infusion at planned dose levels.
Experimental: Regimen B: FT825 + Cetuximab
Participants with advanced epidermal growth factor receptor (EGFR)-expressing solid tumors receive FT825 in combination with cetuximab following chemotherapy in Cycle 1 (each cycle is approximately 61 days). Based on the safety, tolerability, and radiographically confirmed clinical benefit to treatment in Cycle 1, participants may be considered for an additional treatment cycle (Cycle 2 retreatment).
Drug: FT825
FT825 will be administered as an intravenous (IV) infusion at planned dose levels.
Other Names:
  • ONO-8250
Drug: Fludarabine
Fludarabine will be administered as an IV infusion at planned dose levels.
Other Names:
  • FLUDARA
Drug: Cyclophosphamide
Cyclophosphamide will be administered as an IV infusion at planned dose levels.
Drug: Bendamustine
Bendamustine will be administered as an IV infusion at planned dose levels.
Drug: Docetaxel
Docetaxel will be administered as an IV infusion at planned dose levels.
Drug: Cisplatin
Cisplatin will be administered as an IV infusion at planned dose levels.
Drug: Cetuximab
Cetuximab will be administered as an IV infusion at planned dose levels.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with dose limiting toxicities (DLTs)
Time Frame: Up to approximately 29 days
The number of participants with DLTs will be reported.
Up to approximately 29 days
Number of participants with treatment-emergent adverse events (TEAEs)
Time Frame: Up to approximately 2 years
The number of participants with TEAEs will be reported.
Up to approximately 2 years
Severity of AEs
Time Frame: Up to approximately 2 years
Severity of AEs will be determined according to appropriate rating scales for the type of event reported.
Up to approximately 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigator-Assessed Overall Response Rate (ORR)
Time Frame: 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).
Up to approximately 2 years
Investigator-Assessed Duration of Response (DOR)
Time Frame: 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.
Up to approximately 2 years
Progression-Free Survival (PFS)
Time Frame: 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.
Up to approximately 2 years
Overall Survival (OS)
Time Frame: Up to approximately 2 years
OS defined as the time from first dose of study intervention to death from any cause.
Up to approximately 2 years
Plasma Concentration of FT825
Time Frame: At designated time points up to approximately 56 days
The plasma concentration of FT825 will be determined.
At designated time points up to approximately 56 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fate Therapeutics

Investigators

  • Study Director: Study Director, Fate Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2024

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

May 1, 2044

Study Registration Dates

First Submitted

January 27, 2024

First Submitted That Met QC Criteria

January 27, 2024

First Posted (Actual)

February 5, 2024

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FT825-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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