Australian biotechnology company Cyteph has announced the completion of recruitment for its first-in-human Phase 1 clinical trial of CYT-101, a groundbreaking off-the-shelf, HLA-matched CMV-specific T cell therapy being developed to treat recurrent glioblastoma multiforme (GBM).
GBM is one of the most aggressive and lethal forms of brain cancer.
The trial, conducted in collaboration with Briz Brain and Spine and the Newro Foundation, marks a significant milestone for Cyteph’s clinical program and the broader Australian immunotherapy research landscape. GBM remains one of the most treatment-resistant solid tumours in adults, with current therapies offering limited survival benefit and few long-term responses.
CYT-101 represents a novel approach to treating GBM by targeting cytomegalovirus (CMV) antigens, which are expressed on tumour cells but absent from surrounding healthy brain tissue. This feature enables precise targeting of malignant cells while minimising the risk of off-target toxicity.
“We are pleased to have completed enrolment, reflecting the strong demand from clinical collaborators and patients for innovative treatment options for GBM,” said Professor Rajiv Khanna, Chief Scientific Officer and Founder of Cyteph. “This milestone marks an important step forward in our mission to bring transformative therapies to patients with few existing options.”
The Phase 1 study is designed to evaluate the safety, tolerability, and preliminary efficacy of CYT-101 through a dose-escalation framework. Key readouts from the trial are expected by the end of 2025, with results anticipated to inform the design of future clinical studies.
Lead clinical investigator Professor David Walker, neurosurgeon at Briz Brain and Spine, said completing recruitment was a pivotal achievement.
“Completing recruitment is a critical milestone for any clinical program, and it underscores the dedication of our team and the patients who make this research possible,” he said.
The study is funded through CUREator, Australia’s national biotechnology incubator delivered by Brandon BioCatalyst and supported by the Medical Research Future Fund (MRFF).
Cyteph is a spin-out from QIMR Berghofer, one of Australia’s leading medical research institutes. Building on Professor Khanna’s internationally recognised research into CMV-specific immunotherapies, Cyteph aims to develop next-generation allogeneic T cell treatments for cancers with high unmet clinical needs, including GBM and other solid tumours.