RecruitingPhase IInterventional

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 specific advanced cancers, such as ovarian, lung, and head and neck cancers, or synovial sarcoma, where existing treatments aren't very effective. This is the very first time this cell therapy will be given to humans, so the main goals are to understand if it's safe, how much is the right amount to give, and what effects it might have. Participants will receive the treatment through a drip, along with other medicines to prepare their body. The study will last about five years and two months, and while there's no guarantee of benefit, it aims to find a new way to help people with these cancers.

At a glance

Status

Recruiting

Phase

Phase I

Sponsor

Zelluna Immunotherapy AS

Enrolment target

Start

15 May 2026

Estimated completion

01 Dec 2027

Ovarian cancer, squamous non-small-cell lung cancer, synovial sarcoma, head and neck cancer.

What is this study about?

This study is exploring a new treatment called ZI-MA4-1 for different types of advanced cancers, including ovarian cancer, a specific type of lung cancer, synovial sarcoma, and head and neck cancer. These are cancers that have either spread locally or to other parts of the body and can't be removed with surgery. Sadly, for people with these conditions, current treatments often don't work well, and there's a strong need for new options.

ZI-MA4-1 is a new type of treatment using special cells (called cell therapy). Researchers want to see if it can help fight these cancers. Because it's a completely new treatment for humans, the main aim of the study is to find out if it's safe and to figure out the best dose to give. Once they understand the safety and dose, they will then study it further to see how well it works for different cancer types.

The study is being run in phases, starting with a small group of people to carefully increase the dose and watch for any side effects. After finding a safe and effective dose, more people might join to further check its effects. The hope is that ZI-MA4-1 could become a valuable new treatment option for people with these challenging cancers.

Key takeaways

This is a Phase 1 study, focusing on safety and dosage of a new treatment.
It's the first time ZI-MA4-1 will be given to humans.
The study is for specific advanced cancers with limited other treatment options.
Participation involves IV infusions and other medicines that prepare your body.
Potential benefits are unknown, and there are risks due to the new nature of the treatment.
You can stop participating at any time.

Who may be eligible?

To be considered for this study, you must be between 18 and 75 years old and have one of the specific advanced cancers mentioned: ovarian cancer, squamous non-small cell lung cancer, synovial sarcoma, or head and neck cancer. Your cancer must have spread locally or to other parts of your body and cannot be removed by surgery.

You should have already tried at least two other previous cancer treatments (or one if you have synovial sarcoma) and your cancer should have worsened despite these treatments. Importantly, there should be no other standard treatments available or suitable for you, or you may have chosen not to have them. Your general health needs to be good enough to take part, and you'll need to have certain biological markers that show this specific treatment might be right for you.

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 advanced ovarian cancer, specific lung cancer, synovial sarcoma, or head and neck cancer that can't be surgically removed?
Have you already tried at least two (or one for synovial sarcoma) other cancer treatments?
Is your general health good enough to take part in a clinical trial?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll receive the ZI-MA4-1 treatment through a drip into your arm. Before getting ZI-MA4-1, you'll be given two other medicines, fludarabine and cyclophosphamide, which temporarily reduce certain white blood cells in your body. This helps prepare your body for the main treatment.

You will receive the ZI-MA4-1 treatment three times within each 33-day cycle. Most participants will have at least one treatment cycle, and some may have up to two cycles. Throughout the study, you'll have regular hospital visits for check-ups, blood tests, and scans to see how you're responding and to monitor for any side effects. Your total time in the study, including follow-up, could be around 5 years and 2 months.

Potential risks and benefits

It's important to know that because this is the first time ZI-MA4-1 is being given to people, we don't know for sure what benefits or risks it might have. There's no guarantee that your condition will improve. However, it's possible that this new treatment could help address your cancer and improve some of your symptoms, but we don't know how long any benefit might last. On the risk side, since this is a new type of cell therapy, there are unknown risks. Past experiences with similar treatments show possible side effects like a severe immune response (cytokine release syndrome), brain-related issues like confusion or headaches, feeling sick, tiredness, and changes in blood levels. The temporary medicines given before ZI-MA4-1 can increase your risk of infections, tiredness, and bruising. There are also small risks with procedures like biopsies and blood tests. You are free to withdraw from the study at any time.

Locations (2)

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

The Christie NHS Foundation Trust
City only
Manchester, England
The Royal Marsden NHS Foundation Trust
City only
London, England

Common questions

What is ZI-MA4-1?

It's a brand new cell therapy treatment being tested for the first time in people with certain advanced cancers.

Why is this study being done?

To see if ZI-MA4-1 is safe and to find the right dose for patients with specific advanced cancers where current treatments are limited.

Will I definitely get better if I join?

There's no guarantee of improvement, as this is a very early study, and the exact benefits are not yet known.

What are the biggest risks?

Because it's a new treatment, some risks are unknown. There's a chance of strong immune reactions, brain-related issues, and increased infection risk from other medicines given.

How long will I be involved in this study?

The total time for participation, from start to finish, is expected to be about 5 years and 2 months.

How to find out more

Medical and Product Information Enquiry .

ctinfo@zelluna.com - Official trial record

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