Eureka Therapeutics has commenced the Phase I/II ARYA-2 clinical trial of ET140203 ARTEMIS T-cell therapy for the treatment of liver cancer in paediatric patients.

The therapy will be investigated to treat hepatocellular neoplasm not otherwise specified (HCN-NOS), or hepatocellular carcinoma (HCC), relapsed or refractory hepatoblastoma (HB) in paediatric patients.

The multi-centre, open-label, dose-escalation clinical study will evaluate the preliminary efficacy and safety/tolerability of ET140203 T-cells in Alpha-fetoprotein (AFP)-positive/ Human Leukocyte Antigen (HLA)-A2-positive paediatric patients who have relapsed/refractory HB, HCN-NOS, or HCC.

It forms part of Eureka’s liver cancer programme portfolio.

During the ET140203 therapy, T-cells from a patient body are collected and engineered to release Eureka’s ARTEMIS cell receptor and infused into the patient.

The engineered T-cells release a TCR-mimic antibody that targets an AFP-peptide/HLA-A2 complex on cancer cells of the liver.

The company stated that the Phase I segment of the trial is now enrolling participants at Dana-Farber/Boston Children’s Cancer and Blood Disorders Center in the US.

Eureka Therapeutics president and CEO Dr Cheng Liu said: “Eureka recognises the highly unmet medical need in treating paediatric patients with advanced liver cancers.

“We are pleased to be working with Dana-Farber to address it by bringing ARTEMIS T-cell therapies to patients in the clinics.”

The ARYA-2 trial is being run in parallel with the company’s ongoing ARYA-1 and ARYA-3 studies, which assess the ARTEMIS T cells therapy to treat HCC in adult patients.

In the ARYA-1 study, the safety of ET140203 ARTEMIS T cells therapy is being assessed in adult subjects with AFP-positive/HLA-A-2-positive advanced HCC found on liver cancer cells.

The ARYA-3 is evaluating ECT204 T-cell therapy in adult subjects with Glypican 3 (GPC3)-positive HCC.

ET140203 received Fast Track Designation from the US Food and Drug Administration (FDA) to treat HB and HCC in paediatric patients.

It has also received Rare Pediatric Disease Designation to treat HB.