AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

REGN9220 in Combination with Odronextamab in Adult Participants with Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphomas (BCNHLs)

This is a Phase 1 clinical trial looking at a new drug combination for adults with aggressive B-cell non-Hodgkin lymphoma. This type of blood cancer affects white blood cells that normally fight infections. The study is open to patients whose lymphoma has returned (relapsed) or did not respond to standard treatments (refractory). The trial tests an experimental medicine called REGN9220 given together with odronextamab. Both medicines are designed to help your immune system recognise and attack cancer cells. Because this is one of the first times REGN9220 is being given to humans, the main goal is safety. Researchers want to understand how the body handles the drugs, find out what side effects they might cause, and work out the safest dose to use in future studies. Taking part involves regular hospital visits for treatment, blood tests, and health checks.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Regeneron Pharmaceuticals Inc.

Enrolment target

Start

31 Aug 2026

B-cell Non-Hodgkins Lymphoma (B-NHL)

What is this study about?

Non-Hodgkin lymphoma is a type of cancer that starts in the lymphatic system, which is part of the body's immune network. In B-cell lymphoma, white blood cells called B-cells grow out of control. While standard treatments such as chemotherapy and immunotherapy work well for many people, the cancer can sometimes come back or stop responding to treatment. When this happens, doctors need new, effective options.

This clinical trial is testing a combination of two targeted cancer treatments: REGN9220 and odronextamab. Odronextamab is an antibody designed to link cancer cells to healthy immune cells, helping the immune system destroy the cancer. REGN9220 is an experimental medicine designed to work alongside it to boost this anti-cancer effect. Researchers want to see if combining them makes the treatment more powerful than using a single drug alone.

Because this is a Phase 1 study, it is the first time REGN9220 is being tested in humans. The main aim is not yet to prove that the combination cures the disease, but to find out if it is safe, what side effects occur, and what dose works best. Studies like this are vital for building the foundation of future cancer care.

Key takeaways

Tests a new combination of two immune-based medicines: REGN9220 and odronextamab.
Aimed at adults with aggressive B-cell non-Hodgkin lymphoma that has returned or resisted other treatments.
This is a Phase 1 study focused primarily on safety and finding the best dose.
Requires frequent hospital visits for treatment, blood tests, and close monitoring.
Joining is completely voluntary, and you can withdraw at any time.

Who may be eligible?

This trial is for adults aged 18 and over who have been diagnosed with an aggressive form of B-cell non-Hodgkin lymphoma. To be considered, your cancer must be 'relapsed' (it has returned after previous treatment) or 'refractory' (it did not shrink or go away with earlier therapies).

Because Phase 1 studies test new treatments, you must be well enough to carry out everyday activities and have reasonably healthy organ function, particularly your kidneys, liver, and heart. This helps ensure your body can safely handle the study drugs.

You may not be able to join if you have certain active medical conditions, severe infections, or if you have had specific cancer treatments very recently. A doctor on the study team will review your full medical history and perform tests to see if taking part is safe 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.

I am aged 18 or over.
I have been diagnosed with aggressive B-cell non-Hodgkin lymphoma.
My lymphoma has returned or did not respond to previous cancer therapies.
I am well enough to manage my daily tasks and attend regular hospital visits.
I am willing to undergo regular blood tests and body scans.

Answer every question to see your result.

What does participation involve?

If you take part, you will receive the study drugs as an infusion (a slow drip into a vein) at a hospital clinic. Because safety is the top priority, you will need to attend frequent hospital visits, especially during the first few weeks. During these visits, doctors and nurses will monitor your vital signs, take regular blood samples, and check for any side effects. You will also have periodic imaging scans, such as CT or PET scans, to see how your lymphoma is responding. The treatment will continue for as long as it is helping you and not causing harmful side effects. Afterwards, the team will continue to check on your health during follow-up visits.

Potential risks and benefits

The possible benefit of joining is that the combination may help control your lymphoma when other options have stopped working, though this cannot be guaranteed in an early-stage study. The risks include known and unknown side effects, which can range from mild fatigue or nausea to more serious reactions like immune system inflammation or infections. Your safety is monitored very closely throughout. You have the right to leave the study at any time, for any reason, without it affecting your standard NHS care.

Locations (1)

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

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Unverified
Belgium

Common questions

What is a Phase 1 clinical trial?

A Phase 1 trial is the earliest stage of testing a medicine in people. Its main goal is to find out if the treatment is safe, discover any side effects, and find the right dose.

What does 'relapsed or refractory' mean?

'Relapsed' means the cancer came back after a period of improvement. 'Refractory' means the cancer did not respond to the last treatment you received.

Will this study cure my cancer?

It is unlikely that a Phase 1 study will offer a guaranteed cure. The primary focus is testing safety and drug levels, although doctors will watch closely to see if your tumours shrink.

How often will I need to go to the hospital?

Visits will be frequent, especially in the first month. You may need to visit the clinic several times a week initially for infusions, tests, and safety checks.

Can I stop taking part if I change my mind?

Yes. Participation is entirely voluntary. You can withdraw from the study at any point without giving a reason, and your regular medical care will continue.