Cbio Receives Regulatory Clearance to Launch First-in-Human Trial of T-Cell Therapy

COPENHAGEN, Denmark, March 12, 2026 — Cbio A/S has received regulatory clearance to initiate a first-in-human Phase I/IIa clinical trial of novoleucel, the company’s next-generation T-cell therapy designed to enhance immune cell function in cancer patients.

The clinical study will enroll up to 20 patients with persistent or recurrent cervical cancer at Karolinska University Hospital in Stockholm, Sweden. The first patients are expected to receive treatment in the coming months, with initial safety and translational data anticipated by the end of 2026.

The trial marks Cbio’s transition into clinical-stage development and represents a major milestone for the company as it advances its strategy to improve the performance of cell-based immunotherapies in solid tumors.

“The regulatory clearance marks a defining milestone for Cbio,” said Ulrik Cordes, founder and CEO of Cbio. “Patients with recurrent cervical cancer have very limited treatment options once standard therapies fail. We believe that novoleucel has the potential to significantly transform the treatment landscape.”

Addressing immune suppression in tumors

Novoleucel is designed to overcome a key limitation in cancer immunotherapy: oxidative stress within the tumor microenvironment, which can suppress immune cell activity and reduce the effectiveness of T-cell therapies.

The therapy engineers tumor-reactive T cells to better withstand reactive oxygen species (ROS) produced inside tumors. By enhancing the cells’ resistance to oxidative stress, the treatment aims to preserve T-cell persistence and cancer-killing activity within the tumor environment.

The scientific foundation for novoleucel originates from research conducted by Professor Rolf Kiessling and Stina Wickström at the Karolinska Institute, pioneers in adoptive cell therapy.

“For many years we have studied how oxidative stress suppresses immune cells in tumors,” Kiessling said. “By protecting tumor-reactive T cells through activation of the Nrf2 pathway, we aim to improve their persistence and anti-tumor activity.”

The Phase I/IIa study (EUCT 2024-517594-24) will evaluate safety, feasibility of manufacturing and delivery, persistence of infused T cells, and early signals of clinical activity in patients whose disease has progressed after platinum-based chemotherapy and immune checkpoint inhibitors.

Cervical cancer remains a significant global health burden, with more than 660,000 new cases and 349,000 deaths annually worldwide, highlighting the need for more effective treatment options for advanced disease.

Cbio is backed by a group of Nordic and international investors and is currently raising additional funding to support expansion of the clinical program and development of its broader cell therapy platform.

“The start of the clinical program represents an important value inflection point for the company,” said Christian Leroy, board member and investor in Cbio.