AuthorisedTherapeutic exploratory (Phase II)Interventional

A phase II, multicenter study of GlOfitamab in patients with mantle cell Lymphoma and inaDequate response or relapse following CAR T-cell therapy (GOLD)

This research study, called GOLD, is investigating a new medication called glofitamab for adults with Mantle Cell Lymphoma. This is a type of cancer that affects specific white blood cells. The study is for individuals whose cancer has either returned or hasn't responded adequately to a previous treatment known as CAR T-cell therapy. Researchers want to see if glofitamab can help the cancer shrink or disappear, and how long that effect might last. They are also looking at how safe the drug is and what side effects people might experience. If you are aged 18 or over and have Mantle Cell Lymphoma that fits these criteria, this study might be an option to discuss with your doctor.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fondazione Italiana Linfomi Ets

Enrolment target

Start

14 Apr 2026

Mantle Cell Lymphoma

What is this study about?

This study, known as GOLD, is a Phase II clinical trial. This means it's one of the earlier stages of drug testing, where researchers are focused on finding out if a new treatment works and if it's safe enough. The main goal here is to see how many people with Mantle Cell Lymphoma experience a 'complete response' to the new drug, glofitamab. A complete response means the cancer is no longer detectable after treatment.

Mantle Cell Lymphoma is a type of non-Hodgkin lymphoma, which is a cancer that starts in white blood cells called lymphocytes. This study is specifically for patients whose Mantle Cell Lymphoma has either come back after previous treatments or didn't respond well to a specific type of advanced treatment called CAR T-cell therapy. The researchers hope glofitamab can offer a new option for these patients.

They will also be looking at other important things, like how long the treatment keeps the cancer under control (called 'progression-free survival'), how long people live after starting the treatment ('overall survival'), and how long any positive response to the treatment lasts. They'll also carefully track any side effects to understand the safety of glofitamab. Two other drugs, Tocilizumab and Obinutuzumab, might be used alongside or before glofitamab as part of this study.

Key takeaways

This study is for adults with Mantle Cell Lymphoma.
It's for those whose cancer returned or didn't respond well to CAR T-cell therapy.
The new drug being tested is called glofitamab.
The main aim is to see if glofitamab can make the cancer disappear (complete response).
Researchers will also look at safety and side effects.
You must be at least 18 years old to participate.

Who may be eligible?

To join this study, you must be at least 18 years old – there's no upper age limit.

This study is for both men and women. The most important health requirement is that you have Mantle Cell Lymphoma that has either returned or hasn't responded as expected after you've had CAR T-cell therapy.

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 18 years old or older?
Have you been diagnosed with Mantle Cell Lymphoma?
Has your Mantle Cell Lymphoma either returned or not fully responded after CAR T-cell therapy?
Are you able to attend regular hospital appointments for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive doses of the study drug, glofitamab. In some cases, you might also receive other medications called Tocilizumab and Obinutuzumab. These treatments will be given over a period of time, and you'll have regular hospital visits. During these visits, doctors and nurses will perform examinations, take blood and urine samples, and conduct scans to monitor your health and how the treatment is affecting your cancer.

The research team will closely follow your health throughout the treatment period and for some time afterward to track any side effects and see how well the treatment works. The total duration of your participation will involve the treatment period and a follow-up period to monitor your long-term health and the lasting effects of the treatment.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. You might benefit from receiving a new treatment that isn't yet widely available, which could potentially help your cancer. However, there's no guarantee the treatment will work for you, and it could also cause side effects, some of which might be serious. The research team will explain all known side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical 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
Italy

Common questions

What is Mantle Cell Lymphoma?

It's a type of cancer that affects a specific kind of white blood cell in your immune system. It's considered a type of non-Hodgkin lymphoma.

What is CAR T-cell therapy?

It's a advanced treatment where some of a patient's own immune cells are specially modified in a lab to better fight their cancer, then put back into the patient.

What does 'Phase II' study mean?

It means this is an early stage of testing for a new treatment. Researchers are trying to find out if it works and what the main side effects might be, before it's tested on a larger group of people.

What is glofitamab?

Glofitamab is the new drug being tested in this study. It's designed to help your immune system find and attack cancer cells.

Will I have to pay for the treatment?

No, if you're accepted into a clinical trial, the study-related medications and procedures are typically provided at no cost to you.