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Expanded Access Protocol (EAP) for Nonconforming (NC) Afami-cel
Sponsor: USWM CT, LLC
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.
Official title: Expanded Access Protocol for Product Which Does Not Conform to the TECELRA® (Afamitresgene Autoleucel, Suspension for Intravenous Infusion) Commercial Release Specification
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
EXPANDED_ACCESS
Enrollment
Not specified
Start Date
Not specified
Completion Date
Not specified
Last Updated
2026-08-11
Healthy Volunteers
Not specified
Conditions
Interventions
Non-conforming afamitresgene autoleucel
Non-conforming afamitresgene autoleucel, suspension for intravenous infusion (NC afami-cel), single dose administration
Locations (11)
Mayo Arizona
Phoenix, Arizona, United States
Stanford Hospital and Clinics
Stanford, California, United States
Mayo Florida
Jacksonville, Florida, United States
Moffit Cancer Center
Tampa, Florida, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Rochester
Rochester, Minnesota, United States
Memorial Sloan Kettering Cancer Centre
New York, New York, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States