OSLO, Norway, July 13, 2026
Zelluna announced that the first patient has been dosed in the ZIMA-101 Phase 1 clinical trial evaluating ZI-MA4-1, the company’s lead allogeneic T Cell Receptor-based Natural Killer (TCR-NK) cell therapy for patients with advanced MAGE-A4-positive solid tumors. The milestone marks the first clinical evaluation of Zelluna’s proprietary TCR-NK platform and the world’s first MAGE-A4-targeting TCR-NK therapy to enter clinical development. The first patient was treated at The Christie NHS Foundation Trust in the United Kingdom, with patient recruitment activities continuing across multiple tumor types.
First Clinical Evaluation of Proprietary TCR-NK Platform Begins
The first-in-human ZIMA-101 study is designed to evaluate the safety, tolerability, and preliminary anti-tumor activity of ZI-MA4-1 in patients with advanced MAGE-A4-positive solid cancers, including ovarian cancer, squamous non-small cell lung cancer, synovial sarcoma, and head and neck cancer. The multicenter dose-escalation trial is currently active at The Christie NHS Foundation Trust and The Royal Marsden NHS Foundation Trust, with patient identification and screening continuing across all four targeted tumor indications.
Novel Cell Therapy Combines NK Cells with Precision Tumor Targeting
ZI-MA4-1 combines the natural tumor-killing properties of natural killer (NK) cells with affinity-engineered T cell receptors (TCRs) that specifically recognize the cancer-associated antigen MAGE-A4. The allogeneic, off-the-shelf cell therapy is designed to overcome key limitations of existing cell therapies by improving scalability, enhancing tumor targeting, and expanding patient access. The Phase 1 trial follows a standard 3+3 dose-escalation design, with each participant receiving three treatment doses during a single treatment cycle while an Independent Data Monitoring Committee oversees safety assessments at each dose level.
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Initial Clinical Data Expected as Development Advances
Zelluna expects initial clinical data from the ZIMA-101 study to emerge from mid-2026, providing the first clinical insights into the company’s proprietary TCR-NK platform. The program represents a significant milestone for the company as it transitions from preclinical development into human studies and advances a novel cellular immunotherapy approach for solid tumors. If successful, ZI-MA4-1 could establish a new class of off-the-shelf precision cell therapies targeting difficult-to-treat solid cancers through the combination of engineered T cell receptor specificity and natural killer cell biology.
Source: Zelluna press release
