Cbio A/S, a Nordic biotechnology company developing next-generation cell therapies for solid tumours, has received regulatory clearance to initiate a first-in-human Phase I/IIa clinical trial of its investigational T-cell therapy, novoleucel, in patients with persistent or recurrent Cervical Cancer.

The clinical study will enrol up to 20 patients at Karolinska University Hospital in Stockholm. According to the company, the first patients are expected to be treated within the coming months, while initial safety and translational data are anticipated by the end of 2026.

The regulatory clearance marks a key milestone for Cbio as it transitions from preclinical research into clinical development. The company aims to enhance the effectiveness of cell-based therapies for solid tumours by improving immune cell performance within the tumour microenvironment.

Novoleucel is designed to address one of the major challenges in cancer immunotherapy—oxidative stress within tumours, which weakens immune cells and limits their ability to attack cancer. The therapy involves engineered T-cells that are better equipped to withstand reactive oxygen species, helping preserve their anti-tumour activity.

The therapy is based on scientific discoveries from researchers at Karolinska Institute, including work led by Rolf Kiessling and Stina Wickström, who have studied the effects of oxidative stress on immune cells in tumours.

According to Cbio, the trial will focus on patients whose cervical cancer has progressed despite treatment with platinum-based chemotherapy and immune checkpoint inhibitors. The study will evaluate safety, manufacturing feasibility, persistence of infused T-cells and early signals of clinical activity.

The therapy will be produced at the company’s GMP-certified cell therapy manufacturing facility in Copenhagen, which supports the production of clinical-grade immune cell therapies.

Cervical cancer remains a major global health burden, with more than 660,000 new cases diagnosed annually worldwide and approximately 349,000 deaths each year. Patients with recurrent disease often have limited treatment options, highlighting the need for innovative therapeutic approaches.

Cbio is backed by Nordic and international investors and is currently raising additional funding to expand its clinical development programme and further advance its broader cell therapy platform.