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

April 16, 2026 updated by: Iovance Biotherapeutics, Inc.
The objective of this expanded access protocol is to provide access to Out Of Specification (OOS) AMTAGVI treatment to patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Available

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Expanded Access

Expanded Access Type

Expanded Access Type

Describes the category of expanded access under U.S. Food and Drug Administration (FDA) regulations. There are three types of expanded access:
  • Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological product that has not been approved by the FDA. This category also includes access in an emergency situation.
  • Intermediate-size Population: Allows more than one patient (but generally fewer patients than through a Treatment IND/Protocol) access to a drug or biological product that has not been approved by the FDA. This type of expanded access is used when multiple patients with the same disease or condition seek access to a specific drug or biological product that has not been approved by the FDA.
  • Treatment IND/Protocol: Allows a large, widespread population access to a drug or biological product that has not been approved by the FDA. This type of expanded access can only be provided if the product is already being developed for marketing for the same use as the expanded access use.
  • Intermediate-size Population

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Available
        • Banner Health MD Anderson
      • Scottsdale, Arizona, United States, 85258
        • Available
        • HonorHealth
    • California
      • Duarte, California, United States, 91010
        • Available
        • City Of Hope
      • Stanford, California, United States, 94305
        • Available
        • Stanford Hospital
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Available
        • University of Colorado Hospital
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Available
        • Yale New Haven Hospital
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Available
        • Georgetown University Medical Center
    • Florida
      • Miami, Florida, United States, 33136
        • Available
        • University of Miami
      • Orlando, Florida, United States, 32806
        • Available
        • Orlando Health Cancer Institute
      • Tampa, Florida, United States, 33612
        • Available
        • Moffitt Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Available
        • Northside Hospital
      • Atlanta, Georgia, United States, 30322
        • Available
        • Emory University Hospital
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Available
        • Northwestern University
      • Chicago, Illinois, United States, 60637
        • Available
        • University Of Chicago
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Available
        • University of Iowa Hospital
    • Kansas
      • Westwood, Kansas, United States, 66205
        • Available
        • The University of Kansas Cancer Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Available
        • University of Kentucky-Markey Cancer Center
      • Louisville, Kentucky, United States, 40202
        • Available
        • University of Louisville - James Graham Brown Cancer Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Available
        • University of Maryland
      • Baltimore, Maryland, United States, 21287-0013
        • Available
        • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Available
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02215
        • Available
        • Dana Farber Cancer Institute
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Available
        • Barbara Ann Karmanos Cancer Hospital
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Available
        • Washington University - Barnes Jewish Hospital
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Available
        • University Of Nebraska Medical Center
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Available
        • MD Anderson Cancer Center At Cooper
      • Hackensack, New Jersey, United States, 07601
        • Available
        • Hackensack University Medical Center
    • New York
      • New York, New York, United States, 10065
        • Available
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10065
        • Available
        • New York Presbyterian Weill Cornell Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Available
        • Cleveland Clinic
    • Oregon
      • Portland, Oregon, United States, 97239
        • Available
        • Oregon Health and Science University
      • Portland, Oregon, United States, 97213
        • Available
        • Providence Cancer Center Oncology and Hematology Care Clinic
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18105
        • Available
        • Lehigh Valley Health Network
      • Bethlehem, Pennsylvania, United States, 18015-1000
        • Available
        • St. Lukes Hospital
      • Philadelphia, Pennsylvania, United States, 19111
        • Available
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19701
        • Available
        • Thomas Jefferson University
      • Pittsburgh, Pennsylvania, United States, 15224
        • Available
        • West Penn Hospital
      • Pittsburgh, Pennsylvania, United States, 15232
        • Available
        • University of Pittsburgh Medical Center - Hillman Cancer Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Available
        • Avera Cancer Institute
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Available
        • Vanderbilt University
      • Nashville, Tennessee, United States, 37203
        • Available
        • SCRI Oncology Partners
    • Texas
      • Austin, Texas, United States, 78704
        • Available
        • South Austin Medical Center
      • Dallas, Texas, United States, 75246
        • Available
        • Texas Oncology-Baylor Charles A. Sammons Cancer Center
      • Houston, Texas, United States, 77030
        • Available
        • MD Anderson Cancer Center - U of Texas
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Available
        • Intermountain Healthcare
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Available
        • VCU Medical Center (Virginia Commonwealth University)
    • Washington
      • Seattle, Washington, United States, 98109
        • Available
        • Fred Hutchinson Cancer Research Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Available
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Iovance Biotherapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IOV-EAP 402

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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