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

Sponsor: Adaptimmune

Expanded Access
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06617572

Patient View

This EAP provides access to NC afami-cel for patients prescribed TECELRA® who meet specific criteria, including inability to meet commercial specifications and infeasibility of repeat manufacture. Eligible patients must be medically fit, with a confirmed benefit:risk profile. Exclusions include contraindications per TECELRA® USPI. The intervention involves a single dose of NC afami-cel.

Patient Parameters

Program Overview

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.

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

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