The purpose of this expanded access protocol (EAP) is to provide controlled access toAfamitresgene autoleucel, suspension for intravenous infusion that does not meet thecommercial release specification (NC afami-cel). This EAP will be conducted at authorizedtreatment centers where TECELRA® is being administered and where the EAP is approved tobe conducted. Patients who are prescribed TECELRA® , sign the informed consent form, andmeet all entry criteria will be eligible to participate in this protocol.
Not Provided
Genetic: Non-conforming afamitresgene autoleucel
Non-conforming afamitresgene autoleucel, suspension for intravenous infusion (NC
afami-cel), single dose administration
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
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
Adaptimmune Patient Enquiries
215-825-9260
patients@adaptimmune.com
Not Provided