Expanded Access Program of AMTAGVI that is Out of Specification for Commercial Release

Clinical Trial Details

The purpose of this study is to provide patients with AMTAGVI (lifileucel) that is Out of Specification for Commercial Release.

In this study, AMTAGVI will be given intravenously (meaning through a needle in the vein directly into the blood).

Participation is expected to last up to 24 months.

Key Eligibility:

Open to men and women who are eligible for treatment with AMTAGVI per U.S. Prescribing Information
Participants must not have a history of hypersensitivity to cyclophosphamide, mesna, fludarabine, or any component of lifileucel cryopreservation medium

Detailed eligibility will be discussed with the study team.

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Kristyn Senzino
swx9002@med.cornell.edu

Primary Investigator(s)

Barbara Ma, MD

Protocol ID(s)

Weill Cornell Medicine IRB #:

2505028826

ClinicalTrials.gov:

NCT05398640

Status

Open to Enrollment

Age Group

Adult