Zelluna has received the UK Medicines and Healthcare products Regulatory Agency (MHRA) and Research Ethics Committee (REC) approval for its clinical trial application (CTA) to start the ZIMA-101 first-in-human Phase I study of ZI-MA4-1.
ZI-MA4-1 is the company’s lead T cell receptor-natural killer (TCR-NK) cell therapy candidate.
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This advance marks Zelluna’s transition from preclinical research to clinical-stage development of its TCR-NK platform.
The trial will be initiated at The Christie NHS Foundation Trust in Manchester, UK, led by Professor Fiona Thistlethwaite, with participation from Dr Andrew Furness at The Royal Marsden in London.
Initial clinical data is anticipated from mid-2026.
The planned Phase I trial aims to assess the tolerability, preliminary activity, and safety of ZI-MA4-1 in patients with advanced solid cancers, including lung, head, neck, and ovarian.
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By GlobalDataZI-MA4-1 is an off-the-shelf cell therapy designed to pair the tumour-recognition precision of T cell receptors with the cytotoxic activity of natural killer cells.
The UK MHRA supports early-phase clinical development of Advanced Therapy Medicinal Products (ATMPs), providing a framework for innovative therapies such as TCR-NK therapies.
Zelluna CEO Namir Hassan said: “The MHRA and Ethics Committee approvals represent a significant milestone for Zelluna and reflect the strength of the work the team has delivered across science, manufacturing, and regulatory execution.
“Importantly, this first-in-human study is designed not only to evaluate ZI-MA4-1 as a product candidate, but also to generate critical clinical insight into the broader potential of our TCR-NK platform.
“We now move into an important phase of clinical execution and learning for Zelluna as we initiate our first clinical programme and begin to generate clinical insights into the broader potential of our TCR-NK platform.”
Cell & Gene therapy coverage on Clinical Trials Arena is supported by Cytiva.
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