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

Available (expanded access)

Conditions studied: Synovial Sarcoma, Myxoid Liposarcoma

In brief

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.

Key facts

Study ID

NCT06617572

Run by

USWM CT, LLC

Last updated by the study team

2026-02-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 Adaptimmune
• 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

You may not qualify if…

• 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

Where it is running

• Mayo Arizona — Phoenix, Arizona, United States
• Stanford Hospital and Clinics — Stanford, California, United States
• Mayo Florida — Jacksonville, Florida, United States
• Moffit Cancer Center — Tampa, Florida, United States
• Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Mayo Rochester — Rochester, Minnesota, United States
• Memorial Sloan Kettering Cancer Centre — New York, New York, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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