Expanded Access Program of AMTAGVI That is Out of Specification for Commercial Release
1 other identifier
expanded_access
N/A
1 country
48
Brief Summary
The objective of this expanded access protocol is to provide access to Out Of Specification (OOS) AMTAGVI treatment to patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2022
CompletedFirst Posted
Study publicly available on registry
June 1, 2022
CompletedApril 20, 2026
April 1, 2026
May 26, 2022
April 16, 2026
Conditions
Keywords
Interventions
Patients will undergo preparative lymphodepleting chemotherapy. Infusion of lifileucel is then given and is followed by administration of IL-2.
Eligibility Criteria
You may qualify if:
- Eligible for treatment with AMTAGVI per United States Prescribing Information (USPI)
- Have an AMTAGVI product manufactured for commercial treatment; however, the final manufactured product did not meet commercial release criteria but was deemed safe and acceptable for release after risk/benefit assessment
- Patients of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and for 12 months after receiving the last protocol-related therapy
You may not qualify if:
- History of hypersensitivity to cyclophosphamide, mesna, fludarabine, or any component of lifileucel cryopreservation medium
- Ongoing systemic infection
- Cardiopulmonary or renal disorder which may make patient ineligible for treatment with cyclophosphamide, fludarabine or IL-2, at the discretion of the Treating Physician
- Experience a significant worsening in clinical status that would, in the opinion of the Treating Physician, increase the risk of toxicities from treatment with lymphodepleting chemotherapy, AMTAGVI product that is out of specification, or IL-2
- Any other condition, laboratory abnormality and/or pre-treatment assessment that places patient at unacceptable risk if they were to participate in the EAP based on the Treating Physician's judgment
- Pregnant or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
Banner Health MD Anderson
Gilbert, Arizona, 85234, United States
HonorHealth
Scottsdale, Arizona, 85258, United States
City of Hope
Duarte, California, 91010, United States
Stanford Hospital
Stanford, California, 94305, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
University of Miami
Miami, Florida, 33136, United States
Orlando Health Cancer Institute
Orlando, Florida, 32806, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago
Chicago, Illinois, 60637, United States
University of Iowa Hospital
Iowa City, Iowa, 52242, United States
The University of Kansas Cancer Center
Westwood, Kansas, 66205, United States
University of Kentucky-Markey Cancer Center
Lexington, Kentucky, 40536, United States
University of Louisville - James Graham Brown Cancer Center
Louisville, Kentucky, 40202, United States
University of Maryland
Baltimore, Maryland, 21201, United States
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287-0013, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Barbara Ann Karmanos Cancer Hospital
Detroit, Michigan, 48201, United States
Washington University - Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
MD Anderson Cancer Center at Cooper
Camden, New Jersey, 08103, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
New York Presbyterian Weill Cornell Medical Center
New York, New York, 10065, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Providence Cancer Center Oncology and Hematology Care Clinic
Portland, Oregon, 97213, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, 18105, United States
St. Lukes Hospital
Bethlehem, Pennsylvania, 18015-1000, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19701, United States
West Penn Hospital
Pittsburgh, Pennsylvania, 15224, United States
University of Pittsburgh Medical Center - Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57105, United States
SCRI Oncology Partners
Nashville, Tennessee, 37203, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
South Austin Medical Center
Austin, Texas, 78704, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
MD Anderson Cancer Center - U of Texas
Houston, Texas, 77030, United States
Intermountain Healthcare
Salt Lake City, Utah, 84107, United States
VCU Medical Center (Virginia Commonwealth University)
Richmond, Virginia, 23298, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2022
First Posted
June 1, 2022
Last Updated
April 20, 2026
Record last verified: 2026-04