drugset
drugset / Trial / NCT02932956

Glypican 3-specific Chimeric Antigen Receptor Expressed in T Cells for Patients With Pediatric Solid Tumors (GAP)

NCT02932956 ↗

Phase 1 Active not recruiting 10 enrolled Baylor College of Medicine Cancer Prevention Research Institute of Texas · collabCenter for Cell and Gene Therapy, Baylor College of Medicine · collabCookies for Kids' Cancer · collabCuring Kids' Cancer Foundation · collabThe V Foundation · collab
NaSingle-groupOpen-labelTreatment

Summary

This study enrolls patients who have GPC3-positive solid tumors currently. Patients may be considered if the cancer has come back, has not gone away after standard treatment or the patient cannot receive standard treatment. This research study uses special immune system cells called GAP T cells, a new experimental treatment. The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: antibodies and T cells. Antibodies are types of proteins that protect the body from infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. Both antibodies and T cells have been used to treat patients with cancers. They have shown promise, but have not been strong enough to cure most patients. Investigators have found from previous research that they can put a new gene into T cells that will make them recognize cancer cells and kill them. In preclinical studies, the investigators made several genes called a chimeric antigen receptor (CAR), from an antibody called GC33 that recognizes glypican-3, a proteoglycan found on solid tumors including pediatric liver cancers (GPC3-CAR). This study will test T cells genetically engineered with a GPC3-CAR (GAP T cells) in patients with GPC3-positive solid tumors (currently only enrolling liver tumors). The GAP T cells are an investigational product not approved by the Food and Drug Administration. The purpose of this study is to find the biggest dose of GAP T cells that is safe, to see how long they last in the body, to learn what the side effects are and to see if the GAP T cells will help people with GPC3-positive solid tumors. This study enrolls patients who have GPC3-positive solid tumors (currently only enrolling liver tumors).

Timeline

Start
2018-12-17
Primary completion
2021-09-27
Completion
2037-02

Drugs

EvaluationDrugModalityDoseRoute
Subject GAP T cells Cell therapy 1e+07 unknown Other
Subject GAP T cells Cell therapy 3e+07 unknown Other
Subject GAP T cells Cell therapy 1e+08 unknown Other
Subject GAP T cells Cell therapy 3e+08 unknown Other
Subject GAP T cells Cell therapy 1e+09 unknown Other
Background Cyclophosphamide Other / unclassified 500 mg/m2 Intravenous
Background Fludarabine Small molecule 30 mg/m2 Intravenous

Indications

liver cancer