Drugs / ZI-MA4-1
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | UK (MHRA) | — | SMARCA4-deficient sarcoma of thorax | 2025-12-17 | “submission of its Clinical Trial Application (CTA) to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for ZI-MA4-1” zelluna.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT07613723 | May 2026 → Dec 2028 expected | head and neck cancer, non-small cell squamous lung carcinoma, ovarian cancer, synovial sarcoma | Zelluna Immunotherapy AS | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2026-08-17 | Zelluna Immunotherapy AS | Results Zelluna receives Independent Data Monitoring Committee recommendation to continue patient enrolment in ZIMA-101 zelluna.com ↗
Following its review, the IDMC identified no dose-limiting toxicities or other safety concerns that would preclude continuation of the study at the current dose level. |
| 2026-02-20 | Zelluna Immunotherapy AS | Regulatory Zelluna Receives UK MHRA and Ethics Approval to Initiate ZIMA-101 First-in-Human Clinical Trial zelluna.com ↗
The approvals allow Zelluna to initiate the ZIMA-101 study in the United Kingdom, marking a key milestone in the Company’s transition from preclinical to clinical-stage development and representing the first clinical evaluation of its proprietary TCR-NK platform. |
| 2025-12-17 | Zelluna Immunotherapy AS | Regulatory Zelluna Reaches Major Milestone and Submits Clinical Trial Application in the UK for First-in-Human Study of ZI-MA4-1 (ZIMA-101), the World’s First MAGE-A4-Targeting TCR-NK Cell Therapy for Solid Tumours zelluna.com ↗
Oslo, Norway, 17 December 2025 – Zelluna (OSE: ZLNA), a company pioneering allogeneic off-the-shelf cell therapies for cancer, today announced the submission of its Clinical Trial Application (CTA) to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for ZI-MA4-1, the Company’s lead candidate. |
| 2025-12-16 | Zelluna Immunotherapy AS | Results Zelluna Publishes Compelling Preclinical Data for ZI-MA4-1, the World’s First MAGE-A4-Targeting TCR-NK Therapy for Solid Tumours zelluna.com ↗
The paper describes ZI-MA4-1, a novel cell therapy that combines two powerful cancer-fighting mechanisms: the precision solid tumour targeting of T cell receptors (TCRs) with the potent and broad cancer killing ability of Natural Killer (NK) cells. |
| 2025-10-09 | Zelluna Immunotherapy AS | Regulatory Zelluna Receives Positive MHRA Feedback and Strengthens UK Clinical Strategy for ZI-MA4-1 Paving the Way for First-in-Human Trials in the UK zelluna.com ↗
Oslo, Norway, 9 October 2025 – Zelluna (OSE: ZLNA), a company pioneering allogeneic (“off-the-shelf”) T Cell Receptor-based Natural Killer (TCR-NK) cells for the treatment of cancer, today announced it has received positive feedback from the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) following recent scientific advice. |
All press releases naming this drug 8 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ZI-MA4-1 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07613723 ↗ |
| Modality | Cell therapy | “The treatment being investigated in this study is ZIMA4-1, an allogeneic cell therapy product.” NCT07613723 ↗ |
| Route | Intravenous | “administered via IV infusion” NCT07613723 ↗ |