ClinicalTrials.gg
AvailableNCT06617572Updated Aug 11, 2026

Expanded Access Protocol (EAP) for Nonconforming (NC) Afami-cel

An expanded access record providing Non-conforming afamitresgene autoleucel in Synovial Sarcoma and Myxoid Liposarcoma, sponsored by USWM CT, LLC. Available at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by USWM CT, LLC · Expanded access

Study type
Expanded access
Access type
Intermediate-size population
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this expanded access protocol (EAP) is to provide controlled access to Afamitresgene autoleucel, suspension for intravenous infusion that does not meet the commercial release specification (NC afami-cel). This EAP will be conducted at authorized treatment centers where TECELRA® is being administered and where the EAP is approved to be conducted. Patients who are prescribed TECELRA® , sign the informed consent form, and meet all entry criteria will be eligible to participate in this protocol.

02

Conditions studied

  • Synovial Sarcoma
  • Myxoid Liposarcoma
03

In context

Sarcoma, Synovial

133 studies on the registry are indexed under Sarcoma, Synovial; 29 are open to participants now.

Browse Sarcoma, Synovial studies →

Lead sponsor

USWM CT, LLC is the lead sponsor of 9 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient must provide written 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 must have a negative serum or urine pregnancy test within 7 days of initiating lymphodepleting chemotherapy

Exclusion criteria

Exclusion Criteria:

  • Patient has (s) as per the TECELRA® USPI
  • Do not use TECELRA® in adults who are heterozygous or homozygous for HLA-A*02:05P
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Reproductive potential

Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.

Criteria about it usually ask for contraception during the study and for a time after it.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Access details

Study type
Expanded access
Access type
Intermediate-size population

Available treatment

  • GeneticNon-conforming afamitresgene autoleucel

    Non-conforming afamitresgene autoleucel, suspension for intravenous infusion (NC afami-cel), single dose administration

06

Where to request access

11 of 11 sites recruiting
  • Mayo Arizona
    Phoenix, Arizona 85259, United States
    Available
    • Mahesh Seetharam, MD · Principal investigator
  • Stanford Hospital and Clinics
    Stanford, California 94305, United States
    Available
    • Kristen Ganjoo, MD · Principal investigator
  • Mayo Florida
    Jacksonville, Florida 32224, United States
    Available
    • Steven Attia, MD · Principal investigator
  • Moffit Cancer Center
    Tampa, Florida 33612, United States
    Available
    • Mihaela Druta, MD · Principal investigator
  • Northwestern University Feinberg School of Medicine
    Chicago, Illinois 60601, United States
    Available
    • Seth Pollack, MD · Principal investigator
  • Massachusetts General Hospital
    Boston, Massachusetts 02144, United States
    Available
    • Edwin Choy, MD · Principal investigator
  • Dana-Farber Cancer Institute
    Boston, Massachusetts 02215, United States
    Available
    • Michael Wagner, MD · Principal investigator
  • Mayo Rochester
    Rochester, Minnesota 55905, United States
    Available
    • Steven Robinson, MD · Principal investigator
  • Memorial Sloan Kettering Cancer Centre
    New York, New York 10065, United States
    Available
    • Sandra D Angelo, MD · Principal investigator
  • Fox Chase Cancer Center
    Philadelphia, Pennsylvania 19111, United States
    Available
    • Henry Fung, MD · Principal investigator
  • MD Anderson Cancer Center
    Houston, Texas 77030, United States
    Available
    • Dejka Araujo, MD · Principal investigator
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT06617572
Lead sponsor
USWM CT, LLC
Responsible party
Sponsor
First posted
Sep 27, 2024
Last update
Aug 11, 2026

Study contacts

Clinical Scientist
Contact
francine.brophy@usworldmeds.com
866-750-8796
View the source record on ClinicalTrials.gov ↗

Requesting access

Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.

Contact the provider

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion