Expanded Access Protocol (EAP) for Nonconforming (NC) Afami-cel
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.
Patient must provide written informed consent prior to participating in this pro... [+7]
Patient has contraindication(s) as per the TECELRA® USPI [+1]