Expanded Access Protocol (EAP) for Nonconforming (NC) Afami-cel
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.
Sarcoma
N/A
Adults
Chemotherapy - cytotoxic,
Mol. targeted/Immunotherapy/Biologics
Cyclophosphamide,
Fludarabine
Keedy, Vicki
National
Vanderbilt University
07-08-2025
Eligibility
18 Years and older
ALL
Not Available
Inclusion Criteria:
Patient must provide written informed consent prior to participating in this protocol
Patient must provide written informed consent prior to participating in this protocol
Patient must have been prescribed TECELRA
Patient must have been prescribed TECELRA
Patient's commercially manufactured product does not meet the commercial release specification
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 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
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
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
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
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
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
Do not use TECELRA in adults who are heterozygous or homozygous for HLA-A\*02:05P
Patient must provide written informed consent prior to participating in this protocol
Patient must provide written informed consent prior to participating in this protocol
Patient must have been prescribed TECELRA
Patient must have been prescribed TECELRA
Patient's commercially manufactured product does not meet the commercial release specification
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 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
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
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
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
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
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
Do not use TECELRA in adults who are heterozygous or homozygous for HLA-A\*02:05P
