GC LabCell said Thursday it has received regulatory approval for a phase-1/2a trial to expand the indication of anti-cancer cell therapy MG4101 to treat refractory lymphoma.
MG4101 is an investigational cell therapy using natural killer (NK) cells that are isolated from healthy human blood. The proliferated and cultured NK cells kill cancer cells or abnormal cells. Such anticancer treatment has not been commercialized anywhere in the world.
The approved study aims to expand indication, separately from the company’s other trial on the drug in patients with liver cancer. The upcoming test will evaluate the efficacy and safety of MG4101 when used with anticancer, antibody therapy rituximab in patients with recurrent and refractory B-cell non-Hodgkin’s lymphoma.
The company said it decided on the combination therapy to maximize the cancer-fighting effect.
The upcoming phase-1 study will take place at two medical institutions, including the Samsung Medical Center. With an appropriate confirmed dosage, the phase-2 trial will continue with an increased number of patients, GC LabCell said.
“If MG4010 commercialize, patients will enjoy much more convenience as they can receive healthy NK cells from other people whenever they can. Plus, the treatment will be much more affordable than expensive conventional cell therapies,” said Hwang Yu-kyung, director of GC LabCell’s cell therapy research center.