The FDA has accepted an investigational new drug application for autologous genetically modified T-cells expressing affinity enhanced T-cell receptors (TCRs) specific to alpha fetoprotein (AFP) in patients with locally advanced or metastatic hepatocellular carcinoma (HCC).
Acceptance of the application allows Adaptimmune to conduct clinical trials to explore the efficacy of the genetically modified TCR therapy. The company plans to initiate an open-label phase I study to assess the safety and efficacy of the treatment in patients with AFP-positive advanced HCC. Enrollment in the study is expected to commence in the second half of 2016.
“Hepatocellular carcinoma is one of the most common and deadly types of cancer in the world and it represents a significant unmet medical need, as there is a dearth of effective therapies for advanced disease,” said Rafael Amado, Adaptimmune’s Chief Medical Officer. “We are pleased to initiate clinical evaluation of our AFP T-cell therapeutic candidate in this patient population.”
The phase I study to assess the AFP-directed TCR therapy will specifically enroll HLA-A2-positive patients with advanced AFP-positive HCC. The initial enrollment goal will be 30 patients with measurable, histologically confirmed HCC that is not amenable to resection or locoregional therapy or patients with progressive disease following frontline sorafenib.
Additional objectives of the study will include antitumor activity, persistence of genetically modified cells in the body, and the evaluation of the phenotype and functionality of genetically modified cells isolated from peripheral blood or tumor post infusion.