Zelluna received MHRA and Research Ethics Committee (REC) approval on February 20, 2026 to initiate the ZIMA-101 first-in-human Phase I clinical trial for ZI-MA4-1, a T cell receptor-natural killer (TCR-NK) cell therapy12
ZI-MA4-1 is the company's lead candidate and the world's first MAGE-A4-targeting TCR-NK therapy25
This approval marks Zelluna's transition from preclinical research to clinical-stage development12
The ZIMA-101 trial will assess safety, tolerability, and preliminary clinical activity of ZI-MA4-1 in patients with advanced solid cancers, including lung, ovarian, head and neck cancers, and sarcomas12
The trial will be led by Professor Fiona Thistlethwaite at The Christie NHS Foundation Trust in Manchester, with participation from Dr Andrew Furness at The Royal Marsden in London12
Initial clinical data is anticipated from mid-202612
ZI-MA4-1 combines the broad tumor recognition and innate cytotoxic capacity of NK cells with a tumor-specific TCR for precise solid tumor targeting2
Sources:
1. https://www.clinicaltrialsarena.com/news/zelluna-mhra-approval-zima101-trail/
2. https://www.zelluna.com/investors/news/zelluna-receives-uk-mhra-and-ethics-approval-to-initiate-zima-101-first-in-human-clinical-trial
5. https://www.biospace.com/press-releases/zelluna-asa-fourth-quarter-2025-key-regulatory-milestone-achieved-with-cta-submission