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

Launched by ADAPTIMMUNE · Sep 26, 2024

Keywords

ClinConnect Summary

No description provided

Gender

ALL

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