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CAR T-cell Therapy

Regimen A: FT825 for Solid Tumors

Phase 1

Recruiting

Research Sponsored by Fate Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 2 years

Awards & highlights

Study Summary

This trial aims to test the safety and effectiveness of a drug called FT825 (also known as ONO-8250) in combination with monoclonal antibody therapy after chemotherapy in patients with advanced HER

Who is the study for?

This trial is for adults with advanced HER2-positive or other solid tumors. Participants must have measurable disease and be able to receive chemotherapy. They should not have had previous CAR-T therapy, active infections, or any medical conditions that could interfere with the study.Check my eligibility

What is being tested?

The trial is testing FT825 (ONO-8250), a new type of CAR-T cell therapy, combined with standard chemotherapy drugs. Some participants will also receive monoclonal antibodies. The study has two parts: first to find the right dose and then to see how well it works in specific tumor types.See study design

What are the potential side effects?

Possible side effects include reactions related to immune cells (CAR-T) like fever and low blood pressure, as well as typical chemo side effects such as nausea, hair loss, fatigue, and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is advanced or has spread, confirmed by tests.

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My condition cannot be cured with treatment, and I've had treatments specific to my cancer type.

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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with dose limiting toxicities (DLTs)

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

Severity of AEs

Secondary outcome measures

Investigator-Assessed Duration of Response (DOR)

Investigator-Assessed Overall Response Rate (ORR)

Overall Survival (OS)

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Regimen B: FT825 + CetuximabExperimental Treatment7 Interventions

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).

Group II: Regimen A: FT825Experimental Treatment6 Interventions

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cetuximab

2011

Completed Phase 3

~2480

Cisplatin

2013

Completed Phase 3

~1940

Docetaxel

1995

Completed Phase 4

~5620

Bendamustine

2015

Completed Phase 3

~2950

Cyclophosphamide

1995

Completed Phase 3

~3770

Fludarabine

2012

Completed Phase 3

~1100

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Fate TherapeuticsLead Sponsor

21 Previous Clinical Trials

1,450 Total Patients Enrolled

Study DirectorStudy DirectorFate Therapeutics

1,211 Previous Clinical Trials

488,921 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the collective count of participants involved in this clinical investigation?

"A total of 351 eligible individuals are needed to participate in this medical research. Interested patients can enroll at various locations such as the Sarah Cannon Research Institute (SCRI) - Nashville situated in Nashville, Tennessee, and The University of Texas MD Anderson Cancer Center located in Houston, Texas."

Answered by AI

Are there any ongoing efforts to enroll patients in this clinical trial at the moment?

"Indeed, according to the details on clinicaltrials.gov, this investigation is actively enrolling candidates. The trial was initially listed on January 5th, 2024 and most recently revised on January 27th, 2024. It aims to recruit a total of 351 participants from three specified sites."

Answered by AI

What are the primary goals and objectives of this medical study?

"As reported by the study sponsor, Fate Therapeutics, the primary aim of this research is to track the incidence of dose-limiting toxicities (DLTs) over a span of approximately 2 years. Furthermore, secondary outcomes will encompass evaluating Investigator-Assessed Duration of Response (DOR), Progression-Free Survival (PFS), and Overall Survival (OS). DOR refers to the duration from initial documented response until disease progression or death based on RECIST v1.1 criteria. PFS measures time from first intervention dose to disease progression or death according to RECIST v1.1 standards, while OS captures survival time post initial"

Answered by AI