Eureka launches ARTEMIS T cell therapy trial for pediatric liver cancer
Eureka Therapeutics has initiated the Phase I / II ARYA-2 clinical trial of ET140203 ARTEMIS T cell therapy for the treatment of liver cancer in pediatric patients.
Therapy will be investigated to treat unspecified hepatocellular neoplasm (HCN-NOS), or hepatocellular carcinoma (HCC), relapsed or refractory hepatocellular neoplasm (HB) in pediatric patients.
The multicenter, open label, dose escalation clinical study will evaluate the preliminary efficacy and safety / tolerability of ET140203 T cells in pediatric patients positive for alpha-fetoprotein (AFP) / human leukocyte antigen (HLA) – A2-positive who have relapsed / refractory HB, HCN-NOS or HCC.
It is part of the Eureka Liver Cancer Program portfolio.
During ET140203 therapy, T cells from a patient’s body are collected and engineered to release the ARTEMIS cell receptor from Eureka and infused into the patient.
The modified T cells release a TCR-mimicking antibody that targets an AFP-peptide / HLA-A2 complex on liver cancer cells.
The company said the Phase I segment of the trial is now recruiting participants from the Dana-Farber / Boston Children’s Cancer and Blood Disorders Center in the United States.
Eureka Therapeutics Chairman and CEO Dr Cheng Liu said, âEureka recognizes the highly unmet medical need in the treatment of pediatric patients with advanced liver cancers.
âWe are delighted to be working with Dana-Farber to address this by providing ARTEMIS T cell therapies to clinic patients. ”
The ARYA-2 trial is being conducted in conjunction with the Company’s ongoing studies ARYA-1 and ARYA-3, which are evaluating ARTEMIS T cell therapy to treat HCC in adult patients.
In the ARYA-1 study, the safety of ET140203 ARTEMIS T cell therapy was evaluated in adult subjects with AFP-positive / HLA-A-2-positive advanced HCC found in liver cancer cells.
ARYA-3 is evaluating ECT204 T cell therapy in adult subjects with Glypican 3 (GPC3) positive HCC.
ET140203 has received Fast Track designation from the United States Food and Drug Administration (FDA) to treat HB and HCC in pediatric patients.
It has also received the Rare Pediatric Disease designation to treat HB.