NEW YORK – Emeryville, California-based Eureka Therapeutics this week announced that it has initiated a Phase I/II clinical trial of its investigational T-cell therapy, ET140203 Artemis, as a treatment for patients with alpha-fetoprotein (AFP)-positive, HLA-A2-positive advanced hepatocellular carcinoma.
The dose escalation trial, dubbed ARYA-1, will evaluate the safety and recommended dose of the autologous T-cell therapy in roughly 50 patients with locally advanced or metastatic, unresectable hepatocellular carcinoma whose tumors carry at least one HLA-A2 allele. Patients also must have a certain level of AFP, a protein that tends to be elevated in liver cancer. As secondary endpoints, the trial will assess the efficacy of the treatment according to radiographic scans, as well as the persistence of ET140203 T cells circulating in patients' blood over the course of two years.
ET140203 uses Eureka's proprietary Artemis cell receptor platform, which has two components: an antibody-based, antigen-binding domain and an effector domain. The treatment consists of patients' autologous T cells that are harvested then genetically modified to target cancer cells containing AFP.
According to Eureka, the engineered T cells in ET140203 Artemis have demonstrated the ability to target solid tumors in preclinical studies.
"We believe that poor infiltration of T cells into solid tumors is a significant barrier to developing T-cell therapies with curative potential," Eureka's President and CEO Cheng Liu said in a statement. "ET140203 can potentially address this limitation associated with the current generation of CAR and [T-cell receptor] therapies, and we are pleased to be able to bring this therapy into the clinic."