Study on the Safety and Effects of Englumafusp Alfa with Obinutuzumab and Glofitamab for Patients with Relapsed/Refractory B-Cell Non-Hodgkin’s Lymphoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called Relapsed/Refractory B-Cell Non-Hodgkin’s Lymphoma, which is a condition where the cancer returns or does not respond to treatment. The study is testing a new treatment approach using a combination of medications. The main treatment being studied is called Englumafusp Alfa (also known by its code name RO7227166), which is a special type of protein designed to target cancer cells. This treatment is being tested in combination with two other medications, Obinutuzumab and Glofitamab. These medications are given through an intravenous (IV) infusion, which means they are administered directly into the bloodstream.

The purpose of the study is to evaluate the safety and effectiveness of these medications when used together. Participants in the study will receive a pre-treatment dose of Obinutuzumab before starting the combination therapy. The study will be conducted in different phases to determine the best dose and to observe how the body processes the medications. The study will also look at how well the treatment works in reducing the size of the tumors and controlling the disease.

Throughout the study, participants will be closely monitored for any side effects and how their bodies respond to the treatment. The study aims to find the most effective dose that can be safely given to patients. This research is important for developing new treatment options for people with Relapsed/Refractory B-Cell Non-Hodgkin’s Lymphoma and potentially improving their outcomes. The study is expected to continue until 2026, with the goal of gathering comprehensive data on the treatment’s safety and effectiveness.

1 initial treatment

Receive a pre-treatment dose of obinutuzumab through an intravenous (IV) infusion. This is a solution administered directly into the bloodstream.

This step is designed to prepare the body for the subsequent treatments.

2 combination therapy phase I/II

Participate in a dose-escalation study to determine the appropriate dose of englumafusp alfa in combination with obinutuzumab and glofitamab.

Receive these medications through IV infusions. The goal is to find the maximum tolerated dose and evaluate safety and tolerability.

This phase is for patients with relapsed or refractory B-cell non-Hodgkin’s lymphoma.

3 combination therapy phase III

Participate in a dose-expansion study to assess the anti-tumor activity of englumafusp alfa in combination with glofitamab.

Receive these medications through IV infusions. This phase aims to compare the effectiveness of the combination therapy against glofitamab alone.

This phase is for patients with large B-cell lymphoma, follicular lymphoma, and mantle cell lymphoma.

4 monitoring and assessment

Undergo regular assessments to monitor the response to treatment, including imaging tests like FDG-PET/CT scans.

Evaluate the nature and frequency of any side effects or adverse events experienced during the trial.

Assess overall response rate, disease control rate, and progression-free survival.

5 completion and follow-up

Complete the trial by the estimated end date of March 31, 2026.

Participate in follow-up assessments to monitor long-term effects and overall survival.

Who Can Join the Study?

Must be willing and able to stay in the hospital as required by the study and follow all study-related procedures.
Must have a history or current status of a blood cancer that is confirmed by a test and is expected to show certain proteins called CD19 and CD20. The cancer must have come back or not responded to at least one previous treatment, and there should be no other treatment options expected to help extend life.
Must have at least one tumor that can be measured and is at least 1.5 cm in size, as seen on a CT scan.
Must be able and willing to provide a new tissue sample from a safe area, if there is more than one measurable tumor. If a new sample cannot be provided, the most recent tissue sample from the past 6 months should be given, if possible. The sample should not be affected by major events. The preferred sample type is a block of tissue preserved in a special way, but if not available, unstained slides are acceptable.
Must have a performance status of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale, which means being fully active or having some symptoms but being able to carry out light work.
Must have a life expectancy of at least 12 weeks.

Who Cannot Join the Study?

Patients who have a different type of cancer than the one being studied.
Patients who have not experienced a return or worsening of their B-cell Non-Hodgkin’s Lymphoma.
Patients who are not within the specified age range for the study.
Patients who are not able to follow the study procedures or instructions.
Patients who have other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have allergies to the study medications.
Patients who have received certain treatments that are not allowed in the study.
Patients who have infections that are not well controlled.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country
IRCCS Humanitas Research Hospital	Rozzano	Italy
Centre Hospitalier Universitaire De Lille	Lille	France
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital Universitario 12 De Octubre	Madrid	Spain
Odense University Hospital	Odense	Denmark
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Rigshospitalet	Copenhagen	Denmark
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Itpsimud Cdoypl Dhjbxibxiwcwnxyrs	L'hospitalet De Llobregat	Spain
Adzrce Ujdnovddyw Hzmcdsop	Aarhus	Denmark
Adisvbr Oacejmiseqc Pccq Gokbosbr Xvyxr	Bergamo	Italy
Hqkvucgp Vizl dkkranyz	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	13.08.2019
Denmark	Not recruiting	13.08.2019
France	Not recruiting	13.08.2019
Italy	Not recruiting	13.08.2019
Spain	Not recruiting	13.08.2019

Trial locations

Investigated drugs:

Englumafusp Alfa (RO7227166) is an experimental medication being studied for its potential to treat certain types of lymphoma. It is designed to target a protein called CD19, which is found on the surface of some cancer cells. By binding to this protein, Englumafusp Alfa may help the immune system recognize and attack the cancer cells more effectively.

Obinutuzumab is a medication used to treat certain types of blood cancers, including non-Hodgkin’s lymphoma. It works by targeting a protein called CD20 on the surface of cancer cells, helping the immune system to destroy these cells. In this trial, Obinutuzumab is used both as a pre-treatment and in combination with other therapies to enhance their effectiveness.

Glofitamab is another investigational drug being tested for its ability to treat lymphoma. It is designed to engage the immune system to target and kill cancer cells. Glofitamab is being studied both as a standalone treatment and in combination with Englumafusp Alfa to assess its potential benefits in treating various types of lymphoma.

Investigated diseases:

Relapsed/Refractory B-Cell Non-Hodgkin’s Lymphoma – This is a type of cancer that originates in the lymphatic system, specifically affecting B-cells, which are a type of white blood cell. The term “relapsed” refers to the return of the disease after treatment, while “refractory” indicates that the disease does not respond to treatment. It typically presents with symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. The disease can progress by spreading to other parts of the lymphatic system or organs. It is characterized by the uncontrolled growth of abnormal B-cells, which can impair the immune system’s ability to fight infections. The progression of the disease can vary, with some cases advancing slowly and others more rapidly.

Trial ID:

2022-502616-37-00

Protocol code:

BP41072

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Effects of Englumafusp Alfa with Obinutuzumab and Glofitamab for Patients with Relapsed/Refractory B-Cell Non-Hodgkin’s Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?