Expanded Access Program of AMTAGVI That is Out of Specification for Commercial Release
NCT ID: NCT05398640
Last Updated: 2025-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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AVAILABLE
EXPANDED_ACCESS
Brief Summary
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Detailed Description
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Conditions
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Interventions
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OOS AMTAGVI
Patients will undergo preparative lymphodepleting chemotherapy. Infusion of lifileucel is then given and is followed by administration of IL-2.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Iovance Biotherapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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HonorHealth
Scottsdale, Arizona, United States
City of Hope
Duarte, California, United States
Stanford Hospital
Stanford, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Orlando Health Cancer Institute
Orlando, Florida, United States
Northside Hospital
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
University of Iowa Hospital
Iowa City, Iowa, United States
The University of Kansas Cancer Center
Westwood, Kansas, United States
University of Louisville - James Graham Brown Cancer Center
Louisville, Kentucky, United States
University of Maryland
Baltimore, Maryland, United States
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Washington University - Barnes Jewish Hospital
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
MD Anderson Cancer Center at Cooper
Camden, New Jersey, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
St. Lukes Hospital
Bethlehem, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
West Penn Hospital
Pittsburgh, Pennsylvania, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
MD Anderson Cancer Center - U of Texas
Houston, Texas, United States
Intermountain Healthcare
Salt Lake City, Utah, United States
VCU Medical Center (Virginia Commonwealth University)
Richmond, Virginia, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Stephanie Gaillard, Dr.
Role: primary
Other Identifiers
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IOV-EAP 402
Identifier Type: -
Identifier Source: org_study_id
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