Clinical trial NCT06617572: Expanded Access Protocol (EAP) for Nonconforming (NC) Afami-cel
Official title: Expanded Access Protocol for Product Which Does Not Conform to the TECELRA® (Afamitresgene Autoleucel, Suspension for Intravenous Infusion) Commercial Release Specification
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Synovial Sarcoma
Myxoid Liposarcoma
Lead sponsor: Adaptimmune
Sponsor class: INDUSTRY
First posted: 2024-09-27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief 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.


Eligibility criteria: 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 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

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Arizona
state: Arizona
city: Stanford
country: United States
facility: Stanford Hospital and Clinics
state: California
city: Jacksonville
country: United States
facility: Mayo Florida
state: Florida
city: Tampa
country: United States
facility: Moffit Cancer Center
state: Florida
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Rochester
state: Minnesota
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Centre
state: New York
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
References: