First Patient Dosed in Phase 1 Trial of Off-the-Shelf TCR-NK Therapy ZI-MA4-1 for Solid Tumors
Dosing has begun in a Phase 1 trial of ZI-MA4-1, the first MAGE-A4-targeting TCR-NK cell therapy for solid tumours, with initial data expected from mid-2026. The off-the-shelf therapy is being evaluated at two UK sites.
The first patient has been dosed in the ZIMA-101 Phase 1 clinical trial evaluating ZI-MA4-1, the world's first MAGE-A4-targeting T cell receptor-based natural killer (TCR-NK) cell therapy. The treatment was administered at The Christie NHS Foundation Trust in Manchester, UK, to a 58-year-old patient with advanced ovarian cancer.
ZI-MA4-1 is an allogeneic, 'off-the-shelf' therapy that combines natural killer cells with genetically engineered T-cell receptors to target the MAGE-A4 protein, which is expressed in several solid tumour types. The ZIMA-101 trial is a first-in-human, multicentre, dose-escalation study designed to assess the safety, tolerability and preliminary anti-tumour activity of the therapy in patients with advanced MAGE-A4-positive tumours. Indications include ovarian cancer, squamous non-small cell lung cancer, synovial sarcoma, and head and neck cancer. The trial is being conducted at two UK sites: The Christie and The Royal Marsden NHS Foundation Trusts.
The study employs a 3+3 dose-escalation design with three predefined dose levels, with three patients per 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 reviews data following the initial safety observation period before enrolment of the remaining patients at that level.
Zelluna ASA, the Norwegian biotechnology company developing ZI-MA4-1, has partnered with Medpace, a clinical research organization, to provide operations, trial management, regulatory support, data analysis and pharmacovigilance services for the study. The company expects initial clinical data from the ZIMA-101 trial to emerge from mid-2026. In November 2025, Zelluna raised NOK 58.2 million ($6.08 million) through a private placement and retail offering to fund the trial. A first GMP batch of ZI-MA4-1 was manufactured and quality-tested prior to the trial's initiation.