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Synovial Sarcomas / Squamous Non Small Cell Lung Cancer (NSCLC) / Ovarian Cancer · Phase 1 Trial
ClinicalTrials.gov · September 4, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registered Phase 1 first-in-human study of ZI-MA4-1, an allogeneic TCR-NK cell therapy, in patients with advanced solid malignancies. The trial is currently recruiting and has not yet reported results; it is designed to establish safety, tolerability, and the recommended Phase 2 dose across ovarian cancer, squamous NSCLC, synovial sarcoma, and head and neck cancer.
Phase 1, Interventional, Single Group, Open label, Treatment purpose. Ovarian Cancer, Squamous Non-Small Cell Lung Cancer (NSCLC), Synovial Sarcomas, Head and Neck Cancer; age from 18 Years; to 75 Years. Intervention: ZI-MA4-1 (TCR-NK cells). n = 9. 2 sites: United Kingdom.
This is a registered Phase 1 first-in-human study of ZI-MA4-1, an allogeneic TCR-NK cell therapy, in patients with advanced solid malignancies. The trial is currently recruiting and has not yet reported results; it is designed to establish safety, tolerability, and the recommended Phase 2 dose across ovarian cancer, squamous NSCLC, synovial sarcoma, and head and neck cancer.
Primary endpoint is safety/tolerability only; efficacy data are not planned as primary outcomes in this Phase 1 record.
The source did not state who this applies to in practice.
First-in-human Phase 1 dose-escalation trial of a novel allogeneic cell therapy with no results yet reported; registration only.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07613723). This is a study registration, not published results. Lead sponsor: Zelluna Immunotherapy AS. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 9 participants (ESTIMATED). Conditions: Ovarian Cancer, Squamous Non-Small Cell Lung Cancer (NSCLC), Synovial Sarcomas, Head and Neck Cancer. Interventions: BIOLOGICAL: ZI-MA4-1 (TCR-NK cells); DRUG: Cyclophosphamide; DRUG: Fludarabine. Primary outcome measures: Safety and tolerability of ZI-MA4-1 , From baseline through end of study visit (up to 5 years). Brief summary: This study will recruit patients with the following cancer indications: ovarian cancer, squamous non-small cell lung cancer, synovial sarcoma and head and neck cancer, with inoperable locally advanced or metastatic solid tumours. Currently, these patients have a poor prognosis and a relatively short overall survival. There is a lack of meaningful, effective therapies available that improve the outcome for these patients. The treatment being investigated in this study is ZIMA4-1, an allogeneic cell therapy product. This is the first time ZI-MA4-1 will be administered to humans. The study is planned to consist of two parts (A and B). Part A includes up to four dose escalation cohorts and aims to identify the maximum tolerated dose of ZI-MA4-1 and give insight into the recommended Phase 2 dose (RP2D). Part B consists of an expansion cohort and is designed to further evaluate the RP2D identified in Part A across one or more indications. The study procedures and eligibility criteria will be the same for participants in Parts A and B, except for the dose level of ZI-MA4-1.
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