AVAILABLENot Applicable

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

United States

Plain-language summary

The objective of this expanded access protocol is to provide access to Out Of Specification (OOS) AMTAGVI treatment to patients.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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
✕. Pregnant or breastfeeding

NCT IDNCT05398640

SponsorIovance Biotherapeutics, Inc.

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS

Iovance Biotherapeutics Study Team

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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
✕. Pregnant or breastfeeding