Expanded Access Protocol (EAP) for Nonconforming (NC) Afami-cel
- Conditions
- Synovial SarcomaMyxoid Liposarcoma
- Registration Number
- NCT06617572
- Lead Sponsor
- Adaptimmune
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
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
MD Anderson Cancer Center
🇺🇸Houston, Texas, 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