Expanded Access Protocol (EAP) for Nonconforming (NC) Afami-cel
Expanded Access Protocol for Product Which Does Not Conform to the TECELRA® (Afamitresgene Autoleucel, Suspension for Intravenous Infusion) Commercial Release Specification
1 other identifier
expanded_access
N/A
1 country
11
Brief Summary
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.
Trial Health
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11 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2024
CompletedFirst Posted
Study publicly available on registry
September 27, 2024
CompletedFebruary 9, 2026
February 1, 2026
September 17, 2024
February 5, 2026
Conditions
Interventions
Non-conforming afamitresgene autoleucel, suspension for intravenous infusion (NC afami-cel), single dose administration
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- USWM CT, LLClead
Study Sites (11)
Mayo Arizona
Phoenix, Arizona, 85259, United States
Stanford Hospital and Clinics
Stanford, California, 94305, United States
Mayo Florida
Jacksonville, Florida, 32224, United States
Moffit Cancer Center
Tampa, Florida, 33612, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60601, United States
Massachusetts General Hospital
Boston, Massachusetts, 02144, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Mayo Rochester
Rochester, Minnesota, 55905, United States
Memorial Sloan Kettering Cancer Centre
New York, New York, 10065, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2024
First Posted
September 27, 2024
Last Updated
February 9, 2026
Record last verified: 2026-02