Expanded Access Program of AMTAGVI That is Out of Specification for Commercial Release
Expanded Access Program of AMTAGVI That is Out of Specification for Commercial Release
The objective of this expanded access protocol is to provide access to Out Of Specification (OOS) AMTAGVI treatment to patients.
Melanoma
N/A
Adults
Chemotherapy - cytotoxic,
Mol. targeted/Immunotherapy/Biologics
AMTAGVI,
Cyclophosphamide,
Fludarabine,
IL-2,
Mesna
Johnson, Douglas
National
Vanderbilt University
09-18-2025
Eligibility
18 Years and older
ALL
Not Available
Inclusion Criteria:
1. Eligible for treatment with AMTAGVI per United States Prescribing Information (USPI)
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
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
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
1. History of hypersensitivity to cyclophosphamide, mesna, fludarabine, or any component of lifileucel cryopreservation medium
2. Ongoing systemic infection
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
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
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
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
6. Pregnant or breastfeeding
1. Eligible for treatment with AMTAGVI per United States Prescribing Information (USPI)
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
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
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
1. History of hypersensitivity to cyclophosphamide, mesna, fludarabine, or any component of lifileucel cryopreservation medium
2. Ongoing systemic infection
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
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
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
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
6. Pregnant or breastfeeding
