Zelluna Doses First Patient with World's First MAGE-A4-Targeting TCR-NK Therapy in Phase 1 Solid Tumour Trial
核心洞察
Zelluna has dosed the first patient with ZI-MA4-1, the world's first MAGE-A4-targeting TCR-NK cell therapy, in the ZIMA-101 Phase 1 trial at The Christie NHS Foundation Trust.
The first-in-human study evaluates safety, tolerability, and preliminary anti-tumour activity in patients with advanced MAGE-A4-positive solid tumours including ovarian, lung, synovial sarcoma (搜索), and head and neck cancers.
The Royal Marsden NHS Foundation Trust has been activated as a second clinical site, expanding patient recruitment capacity across two leading UK cancer centres.
Zelluna ASA (搜索) has dosed the first patient with ZI-MA4-1 in the ZIMA-101 Phase 1 clinical trial, marking the first time the company's proprietary TCR-NK platform has been evaluated in humans. The milestone was achieved at The Christie NHS Foundation Trust in the United Kingdom, the largest single-site cancer centre in Europe, where Professor Fiona Thistlethwaite serves as Chief Investigator.
ZI-MA4-1 is the world's first MAGE-A4-targeting TCR-NK cell therapy to enter clinical development. The therapy combines the innate tumour-killing properties of natural killer (NK) cells with precision tumour targeting enabled by affinity-engineered T cell receptors (TCRs), designed to address key limitations of existing cell therapies in solid tumours, including scalability, tumour targeting, and access.
"This is a defining milestone for Zelluna and marks the beginning of the clinical evaluation of our proprietary TCR-NK platform," said Namir Hassan, Chief Executive Officer of Zelluna. "Dosing the first patient in ZIMA-101 is the culmination of years of scientific innovation, preclinical research and manufacturing development, and represents the transition from laboratory science to treating patients for the first time with our novel TCR-NK therapy."
Trial Design and Patient Population
ZIMA-101 is a first-in-human, multicentre Phase 1 dose-escalation study evaluating the safety, tolerability, and preliminary anti-tumour activity of ZI-MA4-1 in patients with advanced MAGE-A4-positive solid tumours. The study targets four tumour indications where MAGE-A4 is commonly expressed: ovarian cancer (搜索), squamous non-small cell lung cancer (搜索), synovial sarcoma (搜索), and head and neck cancer (搜索).
The trial follows a 3+3 dose-escalation design with three predefined dose levels and three patients per dose level. Each patient receives three doses on Days 1, 4, and 8 of a treatment cycle. For the first patient at each dose level, an Independent Data Monitoring Committee will review the patient's data following completion of the initial safety observation period before providing recommendations on enrolment of the remaining two patients at that dose level.
Expanded Clinical Footprint
The Royal Marsden NHS Foundation Trust has been activated as the second clinical site for the ZIMA-101 study, with Dr. Andrew Furness serving as principal investigator. The Royal Marsden is one of Europe's leading cancer centres with a strong track record in executing early-stage oncology clinical trials. With both The Christie and The Royal Marsden now active, the programme has full clinical execution capability across two of the UK's leading cancer centres.
Patient identification, pre-screening, and screening activities continue across all four tumour indications included in the study. Zelluna expects initial clinical data from the ZIMA-101 study to emerge from mid-2026.
Professor Fiona Thistlethwaite, Consultant Medical Oncologist at The Christie and honorary professor at The University of Manchester, said: "Dosing the first patient represents an exciting moment for everyone who has worked collaboratively to bring this brand-new class of cellular therapy to the clinic. In the coming weeks and months, we will be monitoring the patient's progress closely and gathering important data from this very innovative first-in-human early-phase trial, which will inform the next stages of patient recruitment."
Zelluna ASA (搜索) is headquartered at the Oslo Cancer Cluster Innovation Park in Oslo, Norway, and is listed on the Oslo Stock Exchange under the ticker ZLNA.