Expanded Access Protocol for Nonconforming Afami-cel

Overview

About this study

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 (ATCs) where TECELRA is being administered and where the EAP is approved to be conducted. Nonconforming (NC), or out of specification (OOS), for this protocol is defined as at least one batch release test not meeting the registered commercial release specification for TECELRA.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 8/09/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Steven Robinson, M.B.B.S.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Steven Attia, D.O.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Mahesh Seetharam, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20592274

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