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AVAILABLE
NCT06617572

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

Sponsor: USWM CT, LLC

View on ClinicalTrials.gov

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

Interventions

GENETIC

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