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RecruitingPhase I/IIInterventional

A Phase I/IIa trial of NVG-222 in blood cancers

This study is testing a new medicine called NVG-222 for people with certain blood cancers. NVG-222 is designed to help your own immune system find and kill cancer cells more effectively. It works by connecting cancer cells to your immune cells (called T cells). The main goals are to find the best and safest dose of NVG-222, learn about its side effects, see what happens to the drug in the body, and find out if it can make cancers smaller or stop them from growing. It's for adults (18+) whose blood cancer has come back or is not getting better with standard treatments.

At a glance

Status
Recruiting
Phase
Phase I/II
Sponsor
Cancer Research UK
Enrolment target
60
Start
30 Nov 2025
Estimated completion
01 Nov 2029

What is this study about?

This clinical trial is testing a new drug called NVG-222 for people with certain types of blood cancer. The drug is designed to boost your body's natural defences, called the immune system, to fight the cancer. NVG-222 works like a bridge, connecting cancer cells directly to your immune cells, specifically a type called T cells. This connection helps your T cells recognise and attack the cancer cells more effectively. What's also clever about this drug is that it has a built-in 'off switch' to help reduce the risk of serious side effects if they start to show, making it potentially safer.

Since NVG-222 is a new medicine, the first goals of this study are to carefully find the best and safest dose for patients. Researchers will also be looking closely at any side effects people might have and how the drug behaves once it's in the body. Once a safe dose is found, the study will then look at whether NVG-222 can actually shrink or control the cancer in a larger group of patients. This is an important step to see if this new approach can help improve cancer treatment.

This trial is for adults aged 18 and over who have specific types of blood cancer. This includes people whose cancer has returned after treatment (relapsed), or whose cancer is no longer responding to the treatments they've had (refractory). You might also be able to join if standard treatments aren't suitable for you, or if you've decided not to have the usual treatments that have been offered. The study is called a 'Phase I/IIa' trial, which means it's a very early stage of testing new medications in people.

Key takeaways

  • Tests a new immune-boosting drug, NVG-222, for blood cancers.
  • Aims to find the safest dose and monitor side effects in humans for the first time.
  • For adults with blood cancer that has returned or is not responding to other treatments.
  • Close monitoring throughout the trial to ensure safety.
  • The drug has an 'off switch' design to help manage potential side effects.

Who may be eligible?

This study is for adults, aged 18 or older, who have been diagnosed with certain types of blood cancer. This includes cancers like some forms of lymphoma and leukaemia. It's important that your cancer cells are likely to have a specific protein called ROR1 on their surface, as the drug NVG-222 targets this.

You would be eligible if your cancer has come back after previous treatments, or if it has stopped responding to standard treatments such as chemotherapy, CAR T-cell therapy, or stem cell transplants. You might also be considered if your doctor believes standard treatments aren't right for you, or if you've chosen not to have them.

There are also some medical checks the team will need to do, like ensuring your general health allows you to take part safely. Your doctor will discuss all the specific criteria with you to see if this study could be an option.

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.

  1. Are you 18 years old or over?
  2. Do you have a type of blood cancer (like certain lymphomas or leukaemias)?
  3. Has your cancer come back or stopped responding to previous treatments?
  4. Is your doctor open to discussing trials as a treatment option?
  5. Can you attend regular appointments and check-ups?
Answer every question to see your result.

What does participation involve?

If you decide to take part, the study involves two main stages. In the first stage (Phase I), one person at a time will start with a very low dose of NVG-222. If there are no serious problems, the next person will receive a slightly higher dose, and this continues until the safest dose is found. Then, in the second part of Phase I, small groups of participants will receive different doses, again starting low, to confirm the best and safest dose.

Once the safest dose is known, the study moves to Phase II. Here, a larger number of people with specific types of blood cancer will receive this established dose of NVG-222. This phase helps researchers understand more about how well the drug works against cancer. You will have regular visits for check-ups, blood tests, and scans to monitor your health, side effects, and how the medicine is working. The study is planned to run from June 2025 to October 2030, and your doctor will explain your individual treatment schedule and how long you might be involved.

Potential risks and benefits

NVG-222 is a new drug, and this is the first time it will be given to people. This means that while we have studied it in the lab and have experience with similar drugs, we don't yet know its full effects in humans. There's a chance it might help shrink or control your cancer, or improve your overall health and how you feel. However, there's also a risk of side effects, some of which could be serious. The study team will monitor you very closely to understand both the benefits and any risks. You are free to withdraw from the study at any time, for any reason, should you wish to.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University College London Hospital
    Unverified
    London, England
  • Guy's Hospital
    Unverified
    London, England

Common questions

What is NVG-222?

NVG-222 is a new drug designed to help your immune system fight cancer cells by connecting them to your immune cells.

Who can take part in this study?

Adults (18+) with certain blood cancers that have come back or stopped responding to usual treatments, or for whom standard treatments aren't suitable.

What are the main aims of this trial?

To find the safest dose of NVG-222, understand its side effects, and see if it can help control or shrink cancer.

How long will the study last?

The study itself is expected to run from June 2025 to October 2030. Your personal involvement will depend on how you respond to the treatment, but your doctor can give you more details.

Will I get the new drug immediately?

The study starts with very low doses, which are gradually increased for individual patients to find the safest and most effective dose before it's given to a larger group.

How to find out more

Stuart Smith

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

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