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Center","Houston","Texas","77030",{"type":28,"coordinates":154},[155,156],-95.36327,29.76328,{"lat":156,"lon":155},[159],{"name":160,"role":36,"phone":7,"phoneExt":7,"email":7},"Dejka Araujo, MD",{"type":162,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100563546",false,"NCT06617572","Expanded Access Protocol (EAP) for Nonconforming (NC) Afami-cel","Expanded Access Protocol for Product Which Does Not Conform to the TECELRA® (Afamitresgene Autoleucel, Suspension for Intravenous Infusion) Commercial Release Specification","Inclusion Criteria:\n\n* Patient must provide written informed consent prior to participating in this protocol\n* Patient must have been prescribed TECELRA®\n* Patient's commercially manufactured product does not meet the commercial release specification\n* Repeat manufacture is not feasible or is not clinically appropriate per Investigator assessment in consultation with Adaptimmune\n* Repeat leukapheresis is not feasible or is not clinically appropriate per Investigator assessment\n* 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\n* Patient deemed medically fit and stable to receive NC afami-cel per Investigator assessment\n* Female patients with reproductive potential must have a negative serum or urine pregnancy test within 7 days of initiating lymphodepleting chemotherapy\n\nExclusion Criteria:\n\n* Patient has contraindication(s) as per the TECELRA® USPI\n* Do not use TECELRA® in adults who are heterozygous or homozygous for HLA-A\\*02:05P","ALL","18 Years","EXPANDED_ACCESS","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). 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