RecruitingPHASE1INTERVENTIONAL

A Study to Test the Safety, Tolerability and Effect of ZI-MA4-1 for Patients With Locally Advanced or Metastatic Solid Malignancies

This study is looking into a new treatment called ZI-MA4-1 for people with advanced ovarian cancer, certain types of lung cancer, synovial sarcoma, or head and neck cancer. These cancers are currently difficult to treat, and existing therapies often don't work well enough. ZI-MA4-1 is a new type of cell therapy, and this is the very first time it will be given to humans. The research will happen in two parts. The first part aims to find the safest and most effective dose of ZI-MA4-1. The second part will then explore this dose further in more patients with these specific cancers. The main goal is to understand if this new treatment is safe, tolerable, and has a positive effect on these serious conditions.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Zelluna Immunotherapy AS

Enrolment target

Start

01 May 2026

Estimated completion

01 Dec 2032

Ovarian Cancer Squamous Non-Small Cell Lung Cancer (NSCLC)Synovial Sarcomas Head and Neck Cancer

What is this study about?

This study is designed for individuals facing certain advanced cancers, specifically ovarian cancer, a type of lung cancer known as squamous non-small cell lung cancer, synovial sarcoma, and head and neck cancer. At a advanced stage, these cancers can be challenging to treat, and the current treatments don't always provide the long-term benefits that doctors and patients hope for. This means there's a real need for new and more effective ways to fight these diseases.

The potential new treatment being tested is called ZI-MA4-1. It's a special kind of cell therapy, which means it uses living cells as part of its approach to medicine. In simple terms, it's hoped that these specially designed cells will help the body's own immune system to target and fight cancer cells more effectively. Because this is a very new treatment, it's the first time it will be given to people. This early stage of testing is crucial for ensuring safety and understanding how it works in the human body.

The study will happen in two main stages. The first stage will involve a small number of patients and will carefully increase the dose of ZI-MA4-1 step-by-step. The main goal here is to find the highest dose that is still safe for patients and to get an idea of what dose might work best. Once that's established, the second stage will involve more patients and will explore that safest and potentially most effective dose in more detail across the different types of cancer mentioned.

Key takeaways

This study is for advanced ovarian, certain lung, synovial sarcoma, and head and neck cancers.
It's testing a new cell therapy called ZI-MA4-1, given to humans for the first time.
The main goals are to check safety, find the best dose, and see how well it works.
Patients need to have specific markers on their cells and tumours.
You must have tried at least one or two previous cancer treatments already.

Who may be eligible?

To be considered for this study, your cancer needs to be advanced or spread (metastatic) and not treatable by surgery. You would need to have one of the specific cancer types being studied: ovarian cancer, a particular type of lung cancer, synovial sarcoma, or head and neck cancer.

There are also some specific biological requirements. Your body must have a certain genetic marker, and your tumour must show a particular protein called MAGE-A4 above a certain level. You also must have already tried at least two previous cancer treatments for most of these cancers (or at least one for synovial sarcoma), and your cancer must have progressed despite these previous therapies. Generally, your overall health should be quite good, meaning you can look after yourself without much help and expect to live longer than three months.

However, you would not be able to join if you've had other cell or gene therapies in the past, or if you're currently receiving other experimental treatments. If you have significant side effects from previous treatments that are still severe, or if you have certain other serious health conditions like some autoimmune diseases or other active cancers (aside from some very early skin cancers or cervical cancers), you would also not be able to take part. Women who are pregnant or breastfeeding cannot participate, and women who could become pregnant must use effective contraception.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 75 years old?
Do you have ovarian cancer, a specific lung cancer, synovial sarcoma, or head and neck cancer that is advanced and can't be operated on?
Has your cancer progressed despite previous treatments (at least 1 or 2 lines depending on your cancer type)?
Are you generally in good health with a good daily activity level (ECOG 0 or 1)?
Are you able to use effective birth control if you are a woman who could become pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new treatment, ZI-MA4-1, alongside other medications like cyclophosphamide and fludarabine, which help prepare your body for the cell therapy. The study involves a series of hospital visits for assessments, blood tests, and scans to monitor your health and how the treatment is working. Initially, these visits might be quite frequent. The full duration of your participation in the study and follow-up will be explained by the study team, but it will involve ongoing checks to see how you are doing after treatment.

Potential risks and benefits

Participating in this study might offer a potential benefit if ZI-MA4-1 proves to be an effective treatment for your specific cancer, especially since current options are limited. However, like all new medical treatments, there are potential risks and side effects that are not yet fully known. As this is the first time this treatment is being given to humans, doctors will be carefully monitoring participants for any unexpected reactions. You would be fully informed of all known risks before deciding to join, and you have the absolute right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

The Royal Marsden NHS Foundation Trust
Verified postcode
London, United Kingdom· Not yet recruiting
The Christie NHS Foundation Trust
Verified postcode
Manchester, United Kingdom· Recruiting

Common questions

What is ZI-MA4-1?

ZI-MA4-1 is a new type of cell therapy, where specially designed cells are used to try and help your body fight cancer. It's an experimental treatment, meaning it's still being tested.

Who can receive this treatment?

This treatment is for adult patients (18-75 years old) with advanced ovarian, specific lung, synovial sarcoma, or head and neck cancers that are no longer responding well to standard treatments.

Will I definitely get the new drug?

Yes, if you meet all the study requirements, you will receive ZI-MA4-1 as part of the study. This is not a study where some people get a placebo (dummy treatment).

How long will the study last for me?

The total duration of your involvement, including follow-up, will be discussed in detail by the study team, as it can vary based on individual circumstances and the study's monitoring schedule.

What if I change my mind about participating?

You have the right to withdraw from the study at any time, for any reason, without needing to explain why, and it will not affect your usual medical care.

How to find out more

Zelluna Immunotherapy

ctinfo@zelluna.com +47 413 80 080 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.