By: IPP Bureau
Last updated : February 24, 2026 5:08 pm
The study will test the company’s lead product, ZI-MA4-1, in patients with advanced solid cancers
Zelluna, a leader in off-the-shelf T Cell Receptor-based Natural Killer (TCR-NK) cell therapies, has secured approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) and Research Ethics Committee (REC) to launch its first-in-human clinical trial, ZIMA-101.
The study will test the company’s lead product, ZI-MA4-1, in patients with advanced solid cancers.
The approvals mark Zelluna’s transition from preclinical research to clinical-stage development and represent the first clinical evaluation of its proprietary TCR-NK platform. The ZIMA-101 trial will assess safety, tolerability, and early clinical activity in cancers including lung, ovarian, head and neck, and sarcomas. Initial data is expected by mid-2026.
“The MHRA and Ethics Committee approvals represent a significant milestone for Zelluna and reflects the strength of the work the team has delivered across science, manufacturing, and regulatory execution,” said Namir Hassan, CEO of Zelluna ASA.
“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.”
ZI-MA4-1 is an off-the-shelf therapy that combines precise tumour targeting via T cell receptors with the broad cancer-killing power of Natural Killer cells. It targets MAGE-A4, a protein present in multiple solid tumours, aiming to overcome limitations that have hindered existing cell therapies in these cancers. The therapy is backed by extensive intellectual property, including a landmark patent covering the TCR-NK field.
The ZIMA-101 trial will be led by Prof Fiona Thistlethwaite at The Christie NHS Foundation Trust (Manchester) and Dr. Andrew Furness at The Royal Marsden (London), two world-leading oncology centers.
“I am delighted that the ZIMA-101 study has received MHRA approval. This is an important step that brings us close to opening the study to patient recruitment,” said Prof Thistlethwaite, Chief Investigator for the trial. “ZI-MA4-1 combines the broad tumour-recognition and innate cytotoxic capacity of NK cells with a tumour-specific TCR which I am optimistic will provide potent anti-tumour activity while minimising the risk of tumour escape.”