MedTrace Logo

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

NCT06241456 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 351

Last updated 2025-12-09

No results posted yet for this 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

  • Advanced Solid Tumor

Interventions

DRUG

FT825

FT825 will be administered as an intravenous (IV) infusion at planned dose levels.

DRUG

Fludarabine

Fludarabine will be administered as an IV infusion at planned dose levels.

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.

Sponsors & Collaborators

Principal Investigators

  • Study Director · Fate Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-05
Primary Completion
2029-05-01
Completion
2044-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06241456 on ClinicalTrials.gov