The objective of this expanded access protocol is to provide access to Out Of Specification (OOS) AMTAGVI treatment to patients.
Description
This program provides access to OOS AMTAGVI (lifileucel) that does not meet commercial release criteria but does meet Iovance clinical trial release criteria. Patients will be followed for safety and efficacy.
Who can participate
Inclusion Criteria:
1. Eligible for treatment with AMTAGVI per United States Prescribing Information (USPI)
2. 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
3. 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
Exclusion Criteria:
1. History of hypersensitivity to cyclophosphamide, mesna, fludarabine, or any component of lifileucel cryopreservation medium
2. Ongoing systemic infection
3. Cardiopulmonary or renal disorder which may make patient ineligible for treatment with cyclophosphamide, fludarabine or IL-2, at the discretion of the Treating Physician
4. 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
5. 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
6. Pregnant or breastfeeding
Interventions
OOS AMTAGVI
BIOLOGICAL
Locations
48
United States (48)
Lehigh Valley Health Network
Allentown , Pennsylvania
Emory University Hospital
Atlanta , Georgia
Northside Hospital
Atlanta , Georgia
University of Colorado Hospital
Aurora , Colorado
South Austin Medical Center
Austin , Texas
University of Maryland
Baltimore , Maryland
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore , Maryland
St. Lukes Hospital
Bethlehem , Pennsylvania
Massachusetts General Hospital
Boston , Massachusetts
Dana Farber Cancer Institute
Boston , Massachusetts
MD Anderson Cancer Center at Cooper
Camden , New Jersey
Northwestern University
Chicago , Illinois
University of Chicago
Chicago , Illinois
Cleveland Clinic
Cleveland , Ohio
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas , Texas
Barbara Ann Karmanos Cancer Hospital
Detroit , Michigan
City of Hope
Duarte , California
Banner Health MD Anderson
Gilbert , Arizona
Hackensack University Medical Center
Hackensack , New Jersey
MD Anderson Cancer Center - U of Texas
Houston , Texas
University of Iowa Hospital
Iowa City , Iowa
University of Kentucky-Markey Cancer Center
Lexington , Kentucky
University of Louisville - James Graham Brown Cancer Center
Louisville , Kentucky
University of Miami
Miami , Florida
Medical College of Wisconsin
Milwaukee , Wisconsin
SCRI Oncology Partners
Nashville , Tennessee
Vanderbilt University
Nashville , Tennessee
Yale New Haven Hospital
New Haven , Connecticut
Memorial Sloan Kettering Cancer Center
New York , New York
New York Presbyterian Weill Cornell Medical Center
New York , New York
University of Nebraska Medical Center
Omaha , Nebraska
Orlando Health Cancer Institute
Orlando , Florida
Fox Chase Cancer Center
Philadelphia , Pennsylvania
Thomas Jefferson University
Philadelphia , Pennsylvania
West Penn Hospital
Pittsburgh , Pennsylvania
University of Pittsburgh Medical Center - Hillman Cancer Center
Pittsburgh , Pennsylvania
Providence Cancer Center Oncology and Hematology Care Clinic
Portland , Oregon
Oregon Health and Science University
Portland , Oregon
VCU Medical Center (Virginia Commonwealth University)
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