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Ready-Made immune cells take on Hard-to-Treat cancers

NCT ID NCT06241456

Disease control Sponsor: Fate Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 1 study tests an experimental therapy called FT825, a type of immune cell that is made in a lab and can be given to any patient without needing to use their own cells. It is being tested in people with advanced solid tumors that have HER2 or other markers. The study will check safety and whether the cells can shrink tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
FT825 (an off-the-shelf CAR T-cell therapy)
What this could lead to
If successful, this could lead to a new treatment option for people with advanced solid tumors that are hard to treat.
What could go wrong
This is an early phase 1 trial focused on safety, so it is not yet known if FT825 will shrink tumors. Side effects from the therapy and chemotherapy are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 351 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

May 2044

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumor

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    14 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Banner MD Anderson Cancer Center

    RECRUITING

    Gilbert, Arizona, 85234, United States

  • Karmanos Cancer Institute

    RECRUITING

    Detroit, Michigan, 48201, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • OU Health Stephenson Cancer Center

    RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • Ohio State University - Comprehensive Cancer Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • Oncology Hematology Care Clinial Trials

    RECRUITING

    Cincinnati, Ohio, 45242, United States

  • Sarah Cannon Research Institute (SCRI) - Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • The University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Thomas Jefferson University, Sidney Kimmel Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • University of California San Diego Moores Cancer Center

    RECRUITING

    La Jolla, California, 92037, United States

  • University of Chicago Medical Center

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Minnesota Medical School

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Yale New Haven Hospital - Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.