INTERNATIONAL: A Study To Test The Safety, Tolerability And Effect OfZI-MA4-1 For Patients With Locally Advanced Or Metastatic SolidMalignancies
Trial ID: NCT07613723
Phase: Phase 1
Status: Recruiting
Last Update Posted: May 2026
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 evaluates ZI-MA4-1, a first-of-its-kind allogeneic TCR-NK cell therapy. Unlike standard T-cell therapies that use a patient’s own cells, ZI-MA4-1 uses donor-derived Natural Killer (NK) cells engineered with a T-cell receptor targeting MAGE-A4, allowing for an off-the-shelf approach that does not require individual cell collection from each patient. Participants receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide before receiving ZI-MA4-1 via intravenous infusion three times per treatment cycle, for up to two cycles. The trial has two parts: dose escalation to establish the maximum tolerated dose, followed by an expansion phase to further evaluate the recommended dose across one or more indications.
Preliminary Effectiveness: As a first-in-human Phase 1 trial, no results have been posted to ClinicalTrials.gov at this time. The study will evaluate objective response rate, disease control rate, best overall response, and long-term safety up to five years.
Study Contact: Zelluna Immunotherapy AS
- Phone: +47 413 80 080
- Email: ctinfo@zelluna.com
Treatment Centers: UK