Active not recruitingPHASE1, PHASE2INTERVENTIONAL

A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of Englumafusp Alfa in Combination With Obinutuzumab and in Combination With Glofitamab Following a Pre-Treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma

This research study is for people in the UK with a type of blood cancer called B-Cell Non-Hodgkin's Lymphoma. This is for individuals whose cancer has returned after treatment or didn't respond to past therapies. The study is testing new combinations of medicines: Englumafusp alfa with Obinutuzumab, and Englumafusp alfa with Glofitamab. These treatments are given through a drip (IV infusion). The main goals are to understand how safe these drug combinations are, how the body handles them, and if they show promise in treating the lymphoma. The study is divided into stages to carefully increase the dose and then expand to more participants.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Hoffmann-La Roche

Enrolment target

498

Start

13 Aug 2019

Estimated completion

31 Mar 2027

Lymphoma, Non-Hodgkin

What is this study about?

This study is investigating new treatment options for a type of cancer called B-cell Non-Hodgkin's Lymphoma. This specific study is for individuals whose lymphoma has either returned after they've had treatment (this is called 'relapsed') or hasn't responded well to the treatments they've tried in the past (this is called 'refractory'). At Patient.info, we understand that facing a cancer diagnosis and treatment can be challenging, and we hope this information helps you understand the study better.

In this study, researchers are looking at combinations of medicines, specifically Englumafusp alfa with Obinutuzumab, and Englumafusp alfa with Glofitamab. These medicines are given through a drip, which means they go directly into your bloodstream. Before receiving the main study drugs, participants will get a dose of Obinutuzumab. The study is trying to find the safest and most effective dose of these new combinations. It's an 'open-label' study, which means both you and your doctors will know which treatment you are receiving.

The study has different parts: an initial stage to find the right dose (Part I and II) and then a later stage that includes more people (Part III) to gather more information once a safe dose is established. The main aims are to understand how safe these new drug combinations are, how your body processes them, and if they show signs of helping to treat the lymphoma. This is often an early step in developing new treatments for cancer.

Key takeaways

Targets B-cell Non-Hodgkin's Lymphoma that has returned or not responded to prior treatment.
Investigates new drug combinations: Englumafusp alfa with Obinutuzumab and Englumafusp alfa with Glofitamab.
Aims to assess safety, how drugs work in the body, and early signs of effectiveness.
Involves intravenous (drip) administration of medications.
Open to adults aged 18 and over, with specific health and cancer criteria.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is open to adults aged 18 and over who have been diagnosed with B-cell Non-Hodgkin's Lymphoma. Your lymphoma must be confirmed by a biopsy to have specific markers called CD19 and CD20, which are important for these new treatments to work. Your cancer must also have either returned after previous treatment or not responded to at least one prior therapy.

To be considered, your overall health will be assessed, including how well your liver, kidneys, and blood are working. You would also need to be well enough to take part in the study, which doctors measure using a standard scale (ECOG performance status 0 or 1, or up to 2 for some participants in Part III). This means you should be able to carry out most of your daily activities fairly easily.

There are also some things that might prevent you from joining. For example, if you have certain infections like hepatitis B, hepatitis C, or HIV, or if you have other serious medical conditions that your doctor thinks would make participating unsafe. Women who are pregnant or breastfeeding cannot take part, and all participants must agree to use reliable contraception if there's any chance of pregnancy during the study.

Quick self-check

Are you 18 years old or older?
Do you have B-cell Non-Hodgkin's Lymphoma?
Has your lymphoma come back or not responded to previous treatments?
Are you generally well enough to participate in a study?
Are you able to use effective contraception if applicable?
Do you not have certain infections like active hepatitis B, C, or HIV?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to participate in this study, the total duration can vary, as it includes different stages of treatment and follow-up. You will receive the study medications (Englumafusp alfa, Obinutuzumab, and/or Glofitamab, and potentially Tocilizumab to manage side effects) through an intravenous (IV) drip. There will be an initial dose of Obinutuzumab given up to seven days before you start the main study drugs.

Taking part will involve regular visits to the clinic for medical check-ups, blood tests to monitor your health and how the treatment is affecting you, and scans (like CT scans) to check the size of your lymphoma. You might also be asked to provide a fresh biopsy if it's safe to do so, to help researchers understand your cancer better. The study also tracks any side effects you might experience. After your treatment period, there will be follow-up visits to continue monitoring your health and the long-term effects of the treatment.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as gaining access to new treatments before they are widely available. While these treatments are experimental, they could improve your condition or overall quality of life. However, like all medications, those in this study carry potential risks and side effects. These will be thoroughly explained to you by the study team. Some of the medications, like Tocilizumab, are given to help manage certain side effects. It's important to remember that your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (35)

City of Hope Medical Center
Pasadena, United States
University of California San Francisco
San Francisco, United States
Washington University School of Medicine
St Louis, United States
The University of Texas MD Anderson Cancer Center
Houston, United States
Peter Maccallum Cancer Centre
Melbourne, Australia
The Alfred Hospital
Melbourne, Australia
UZ Gent
Ghent, Belgium
Queen Elizabeth II Health Sciences Centre
Halifax, Canada
Jewish General Hospital
Montreal, Canada
Beijing Cancer Hospital
Beijing, China
Shandong Cancer Hospital
Jinan, China
Fudan University Shanghai Cancer Center
Shanghai, China

+23 more sites — see the official record for the full list.

Common questions

What is Non-Hodgkin's Lymphoma?

It's a type of cancer that starts in white blood cells called lymphocytes, which are part of the body's immune system.

What does 'relapsed/refractory' mean?

Relapsed means the cancer has returned after treatment. Refractory means the cancer did not respond to previous treatments.

How will the study drugs be given?

All the study medications will be given through a drip into a vein (intravenously).

Why is a pre-treatment dose of Obinutuzumab given?

This dose is given beforehand to help prepare your body for the main study drugs and manage potential early side effects.

Will I know which treatment I am receiving?

Yes, this is an 'open-label' study, meaning both you and your medical team will know which drugs you are getting.