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NCT06241456 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Advanced Solid Tumor, sponsored by Fate Therapeutics.

Recruiting
Registry status
Phase 1
Development phase
351
Enrollment target
14
Study locations

NCT06241456 is a Phase 1 study of Advanced Solid Tumor that is actively recruiting participants, run by Fate Therapeutics. The registered enrollment target is 351 participants, above the 191-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (84% higher). The trial reports 14 study locations across 13 states.

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The verdict

NCT06241456, a Phase 1 study of Advanced Solid Tumor, is actively recruiting participants, sponsored by Fate Therapeutics.

RECRUITING
Registry status
Phase 1
Development phase
351 participants
Enrollment target
14
Study locations

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

22 total trials

What the Registry Record Tells You About NCT06241456

The ClinicalTrials.gov registry entry for NCT06241456 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 351 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 191-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (84% higher). The listed sponsor is Fate Therapeutics, which has 22 total studies on file at ClinicalTrials.gov.

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.

NCT06241456 reports 14 study locations spanning 13 distinct geographic areas - top geographies include Ohio, Arizona, California.

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.

What interventions are being tested in trial NCT06241456?

The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Docetaxel (DRUG), Bendamustine (DRUG), FT825 (DRUG).

Who is sponsoring clinical trial NCT06241456?

This trial is sponsored by Fate Therapeutics, which has 22 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.