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Last-Resort cell therapy offered to sarcoma patients

NCT ID NCT06617572

Disease control Sponsor: USWM CT, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 12, 2026 · Updated 2 times

Summary

This expanded access program offers a cell therapy called afamitresgene autoleucel (afami-cel) to people with synovial sarcoma or myxoid liposarcoma whose manufactured dose didn't meet commercial standards. Eligible patients have no other feasible treatment options. The therapy is given as a single intravenous infusion.

What this could mean

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

Active substance
afamitresgene autoleucel (afami-cel), a cell therapy made from the patient's own immune cells
What this could lead to
If this works, it could provide a treatment option for patients with synovial sarcoma or myxoid liposarcoma who have no other alternatives.
What could go wrong
This is an expanded access program, not a formal trial, so data on effectiveness and safety is limited. The product does not meet commercial specifications, meaning its quality or potency may be lower than standard.

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.

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

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: * Patient must provide written informed consent prior to participating in this protocol * Patient must have been prescribed TECELRA® * Patient's commercially manufactured product does not meet the commercial release specification * Repeat manufacture is not feasible or is not clinically appropriate per Investigator assessment in consultation with per consultation with USWM CT * Repeat leukapheresis is not feasible or is not clinically appropriate per Investigator assessment * The Investigator has confirmed a favorable benefit:risk profile, following sponsor evaluation of the NC afami-cel, and deems proceeding with treatment under this EAP is in the best interest of the patient * Patient deemed medically fit and stable to receive NC afami-cel per Investigator assessment * Female patients with reproductive potential must have a negative serum or urine pregnancy test within 7 days of initiating lymphodepleting chemotherapy Exclusion Criteria: * Patient has contraindication(s) as per the TECELRA® USPI * Do not use TECELRA® in adults who are heterozygous or homozygous for HLA-A\*02:05P

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Conditions

The condition(s) this trial relates to.

myxoid liposarcoma synovial sarcoma

As listed by the trial registrant

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

Myxoid liposarcoma Synovial sarcoma

How to take part

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

  1. The places running it

    11 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

  • Dana-Farber Cancer Institute

    AVAILABLE

    Boston, Massachusetts, 02215, United States

  • Fox Chase Cancer Center

    AVAILABLE

    Philadelphia, Pennsylvania, 19111, United States

  • MD Anderson Cancer Center

    AVAILABLE

    Houston, Texas, 77030, United States

  • Massachusetts General Hospital

    AVAILABLE

    Boston, Massachusetts, 02144, United States

  • Mayo Arizona

    AVAILABLE

    Phoenix, Arizona, 85259, United States

  • Mayo Florida

    AVAILABLE

    Jacksonville, Florida, 32224, United States

  • Mayo Rochester

    AVAILABLE

    Rochester, Minnesota, 55905, United States

  • Memorial Sloan Kettering Cancer Centre

    AVAILABLE

    New York, New York, 10065, United States

  • Moffit Cancer Center

    AVAILABLE

    Tampa, Florida, 33612, United States

  • Northwestern University Feinberg School of Medicine

    AVAILABLE

    Chicago, Illinois, 60601, United States

  • Stanford Hospital and Clinics

    AVAILABLE

    Stanford, California, 94305, United States

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