This feedback provides alignment on the preclinical, manufacturing, clinical and regulatory pathway for ZI-MA4-1 and supports Zelluna’s planned Clinical Trial Application (CTA) submission later this year, it states.

“Receiving positive scientific advice from the MHRA is an important milestone as we prepare to bring ZI-MA4-1 into the clinic,” says Namir Hassan, CEO of Zelluna. “With the involvement of world-class investigators and centres such as The Christie and The Royal Marsden, we are building strong momentum towards initiating a UK-based trial that could generate the first safety and efficacy data in 2026. This progress showcases the talent and dedication of our team, and our shared commitment to advancing a novel, scalable and accessible “off the shelf” cell therapy for patients with solid tumors.”

Preparations for the first-in-human trial of ZI-MA4-1

In parallel, Zelluna has advanced preparations for the first-in-human trial of ZI-MA4-1 by engaging with leading UK cancer centres and appointing Professor Fiona Thistlethwaite, Medical Oncology Consultant at The Christie in Manchester, as proposed Chief Investigator. The Christie, one of Europe’s leading cancer centres and a major hub for advanced cell therapy research, will serve as a lead site for the study. Both Professor Fiona Thistlethwaite at The Christie and Dr. Andrew Furness at The Royal Marsden in London, a global leader in oncology and early-phase cell therapy studies, are expected to play central roles in the trial and have contributed to shaping its design and development strategy.

Subject to CTA approval, the proposed Phase I trial will be an open-label, dose-escalation basket study evaluating the safety, tolerability and preliminary efficacy of ZI-MA4-1 across multiple solid tumors.