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RECRUITING Phase 1

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

NCT06241456 · View on ClinicalTrials.gov ↗

Study 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.

Conditions Studied

Interventions

  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • DRUG Docetaxel
  • DRUG Bendamustine
  • DRUG FT825

Study Locations (14)

Ohio

  • Oncology Hematology Care Clinial Trials — Cincinnati
  • Ohio State University - Comprehensive Cancer Center — Columbus

Arizona

  • Banner MD Anderson Cancer Center — Gilbert

California

  • University of California San Diego Moores Cancer Center — La Jolla

Connecticut

  • Yale New Haven Hospital - Yale Cancer Center — New Haven

Illinois

  • University of Chicago Medical Center — Chicago

Michigan

  • Karmanos Cancer Institute — Detroit

Minnesota

  • University of Minnesota Medical School — Minneapolis

Missouri

  • Washington University School of Medicine — St Louis

Trial Details

FieldValue
Enrollment Target 351 participants
Start Date 2024-01-05
Est. Completion 2044-05-01
Phase Phase 1

Sponsor

Fate Therapeutics

5 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06241456

The ClinicalTrials.gov registry entry for NCT06241456 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 351 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fate Therapeutics, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Advanced Solid Tumor appearing as the primary indexed condition, and to 5 interventions — of which Cyclophosphamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06241456 reports 14 study locations spanning 13 distinct geographic areas — top geographies include Ohio, Arizona, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06241456 about?

NCT06241456 is a clinical study titled "FT825/ONO-8250, an Off-the-Shelf, HER2 CAR-T, With or Without Monoclonal Antibodies in 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 ...

What is the current status of trial NCT06241456?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 351 participants. The study started on 2024-01-05. Estimated completion is 2044-05-01.

What conditions does trial NCT06241456 study?

This clinical trial studies the following conditions: Advanced Solid Tumor. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06241456?

The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Docetaxel (DRUG), Bendamustine (DRUG), FT825 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06241456?

This trial is sponsored by Fate Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06241456 being conducted?

This trial has 14 study locations across Arizona, California, Connecticut, Illinois, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial