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

Karmanos Trial ID

2025-040

NCT ID

NCT05398640

Age Group

Adult

Scope

National

Phase

N/A

Principal Investigator

Joseph
Uberti, M.D., Ph.D.
Oncology - Hematology, Oncology - Medical View Profile

Objective:

Primary Objective:

To provide access to OOS AMTAGVI

Safety Objective:

To assess safety of OOS AMTAGVI (Grade 3 and higher Adverse Events ([AEs]; and Serious Adverse Events [SAEs])

Efficacy Objective:

To assess efficacy of OOS AMTAGVI (Day 0) using response rate as assessed by investigator, and as measured by Overall Survival

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Eligibility

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Locations

Locations

Karmanos Cancer Institute - Detroit Headquarters

4100 John R
Detroit, MI 48201
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Phone: 1-800-527-6266

Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 1-800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices