INTERNATIONAL: A Study To Test The Safety, Tolerability And Effect Of ZI-MA4-1 ForPatients With Locally Advanced Or Metastatic Solid Malignancies
Trial ID: NCT07613723
Phase: Phase 1
Status: Recruiting (UK)
Last Update Posted: July 2026
Please Note: Update July 2026: The first patient has been dosed at The Christie NHS Foundation Trust, marking the official start of clinical treatment in ZIMA-101. Initial clinical data is expected to emerge from mid-2026. Learn More: https://zelluna.com/investors/news/zelluna-doses-first-solid-tumour-patient-with-zi-ma4-1-in-the-zima-101-phase-1-trial
Eligibility: Adults aged 18 to 75 with inoperable locally advanced or metastatic synovial sarcoma, ovarian cancer, squamous non-small cell lung cancer, or head and neck cancer who are HLA-A*02:01 positive and whose tumors express the MAGE-A4 protein above a defined threshold. Synovial sarcoma patients must have received at least one prior line of therapy. Patients must have measurable disease and an ECOG performance status of 0 or 1.
Overview: This first-in-human Phase 1 trial (ZIMA-101) evaluates ZI-MA4-1, an allogeneic “off-the-shelf” TCR-NK cell therapy developed by Zelluna ASA. Unlike therapies that use a patient’s own cells, ZI-MA4-1 uses donor-derived NK cells engineered to target MAGE-A4-expressing tumors. Patients receive lymphodepleting chemotherapy, then ZI-MA4-1 by IV infusion across up to two treatment cycles, first to establish a safe dose, then to evaluate its effect.
Preliminary Effectiveness: As a first-in-human trial, no results have been posted yet. The study will track response rate, disease control, and long-term safety over five years.

Study Contact:

Namir Hassan, CEO

Geir Christian Melen, CFO

Treatment Centers:
United Kingdom

  • The Christie NHS Foundation Trust, Manchester (active)
  • The Royal Marsden (active)

More Information: zelluna.com/investors/news/zelluna-asa-activates-first-clinical-site-for-zima-101-marking-entry-into-clinical-execution | zelluna.com