This is a phase 2 research study that enrolls adult subjects with Nonseminomatous Germ Cell
Tumors (NSGCT). The purpose of this study is to create a repository and explore the presence
of modified T cells in the subject's plasma or tumors.
This study collects biospecimens (such as tumor tissue, blood, and modified T cells) that can
be used in future research studies. The collected specimens can help to examine whether the
modified T cells are present in the body and tumor. If the modified T cells are present in
the body, and how long they last. They also will use the specimen to identify ways to improve
treatment options for a future cancer patient.
Research with blood, tissue, or body fluids (specimens) can help researchers understand how
the human body works. Sometimes researchers collect and store specimens and use them for
different kinds of research or share them with other scientists; this is called a specimen
repository or "biobank." Research with biospecimens might help to introduce new tests to find
diseases or new ways to treat diseases.
The body has different ways of fighting infection and disease. No single way seems perfect
for fighting cancer. This research study combines two different ways of fighting disease:
antibodies and T cells. Antibodies are proteins that protect the body from disease caused by
bacteria or toxic substances. Antibodies work by binding those bacteria or substances, which
stops them from growing and causing bad effects. T cells, also called T lymphocytes, are
special infection-fighting blood cells that can kill other cells, including tumor cells or
cells that are infected. Both antibodies and T cells have been used to treat patients with
cancers. They both have shown promise, but neither alone has been sufficient to cure most
patients. This study is designed to combine both T cells and antibodies to create a more
effective treatment called autologous T lymphocyte chimeric antigen receptor cells targeted
against the CD30 antigen (ATLCAR.CD30) administration.
Prior trials have shown the safety of ATLCAR.CD30 product was administered to subjects with
lymphomas. This study was planned based on the safety and efficacy data from previous studies
(NCT02690545 and NCT02917083).
Phase:
Phase 2
Details
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborator:
University Cancer Research Fund at Lineberger Comprehensive Cancer Center