This phase I trial studies the effects of immunotherapy IL-15 GPC3-CAR T cells (CATCH T cells), a specialized treatment made from T cells, a type of immune cell in your blood, can help treat those with liver cancer. Chemotherapy drugs such as cyclophosphamide and fludarabine work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. In the lab, several genes called a chimeric antigen receptor (CAR) are made, from an antibody called GC3 3. The antibody GC33 recognizes a protein called GPC3 which is found on the liver tumor. This CAR is called a GPC3-CAR. To make this CAR more effective, gene encoding a protein IL15 is also added. This protein helps CAR T cells grow better and stay in the blood longer so that they may kill tumors better. The mixture of GPC3-CAR and IL15 killed tumor cells better in the laboratory when compared with CAR T cells that did not have IL15. This study will test T cells that have been made (called genetic engineering) with the IL15 GPC3-CAR (CATCH T cells) in patients with GPC3-positive liver cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT05103631.
Locations matching your search criteria
United States
Texas
Houston
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterStatus: Active
Contact: Tannaz Armaghany
Phone: 713-798-3750
Center for Cell and Gene TherapyStatus: Active
Contact: Tannaz Armaghany
Phone: 713-798-3750
PRIMARY OBJECTIVE:
I. To determine the safety of escalating doses of an intravenous injection of autologous anti-glypican-3 CAR-IL-15-iC9-expressing T-lymphocytes (15.GPC3-CAR T cells) in patients with GPC3-positive hepatocellular carcinomas after lymphodepleting chemotherapy.
SECONDARY OBJECTIVES:
I. To determine the maximum tolerated dose (MTD) of 15.GPC3-CAR T cells in treating patients with GPC3-positive hepatocellular carcinomas after lymphodepleting chemotherapy.
II. To assess the anti-tumor effect of infused 15.GPC3-CAR T cells in patients with GPC3-positive hepatocellular carcinomas.
EXPLORATORY OBJECTIVE:
I. To assess the in vivo persistence, phenotype and functional activity of infused 15.GPC3-CAR T cells in patients with GPC3-positive hepatocellular carcinomas.
OUTLINE: This is a phase II dose-escalation study of 15.GPC3-CAR T followed by a phase II study.
Patients receive cyclophosphamide intravenously (IV) over 1 hour and fludarabine IV over 30 minutes on days -4, -3, and -2. Patients receive 15.GPC3-CAR T IV between day 0 to 2. Patients also undergo contrast enhanced computer tomography (CT) or magnetic resonance imaging (MRI) before chemotherapy and 4 weeks after CAR T cell infusion.
After completion of study treatment, patients are followed up every 3 months for 1 year, every 6 months for 4 years and then every year for the next 10 years.
Lead OrganizationBaylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Principal InvestigatorTannaz Armaghany