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

August 10, 2026 updated by: USWM CT, LLC

Expanded Access Protocol for Product Which Does Not Conform to the TECELRA® (Afamitresgene Autoleucel, Suspension for Intravenous Infusion) Commercial Release Specification

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.

Study Overview

Status

Available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85259
        • Available
        • Mayo Arizona
    • California
      • Stanford, California, United States, 94305
        • Available
        • Stanford Hospital and Clinics
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Available
        • Mayo Florida
      • Tampa, Florida, United States, 33612
        • Available
        • Moffit Cancer Center
    • Illinois
      • Chicago, Illinois, United States, 60601
        • Available
        • Northwestern University Feinberg School of Medicine
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Available
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02144
        • Available
        • Massachusetts General Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Available
        • Mayo Rochester
    • New York
      • New York, New York, United States, 10065
        • Available
        • Memorial Sloan Kettering Cancer Centre
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Available
        • Fox Chase Cancer Center
    • Texas
      • Houston, Texas, United States, 77030
        • Available
        • MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

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 per consultation with USWM CT
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

USWM CT, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

September 17, 2024

First Submitted That Met QC Criteria

September 26, 2024

First Posted (Actual)

September 27, 2024

Study Record Updates

Last Update Posted (Actual)

August 11, 2026

Last Update Submitted That Met QC Criteria

August 10, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADP-0044-999

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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