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Study on the Safety and Effectiveness of Glofitamab and Obinutuzumab for Patients with Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called relapsed/refractory B-cell non-Hodgkin's lymphoma. This is a condition where a type of white blood cell, known as B-cells, becomes cancerous and either returns after treatment or does not respond to treatment. The study is testing a new treatment approach using two medications: Glofitamab and Obinutuzumab. Glofitamab is a special type of protein designed to help the immune system target and destroy cancer cells. Obinutuzumab is another protein that helps the immune system attack cancer cells and is given as a pre-treatment to prepare the body for Glofitamab.

The purpose of the study is to find the best dose of Glofitamab when used alone and in combination with Obinutuzumab, and to understand how safe and effective these treatments are for patients with this type of lymphoma. Participants in the study will receive these medications through an infusion, which means the medicine is given directly into the bloodstream through a vein. The study will monitor how the body responds to the treatment, including any side effects and how well the cancer responds.

Throughout the study, doctors will carefully observe the participants to ensure their safety and to gather information on how the treatment affects the cancer. The study aims to provide valuable insights into the potential benefits and risks of using Glofitamab and Obinutuzumab for treating relapsed/refractory B-cell non-Hodgkin's lymphoma, which could lead to new treatment options for patients in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment

    Receive a single dose of obinutuzumab (Gazyvaro) through an intravenous infusion. This is a pre-treatment step to prepare for the main medication.

    This step is crucial for preparing the body to respond to the subsequent treatments.

  2. Step 2

    Glofitamab administration

    Begin receiving glofitamab through intravenous infusion. The dosage will be gradually increased to determine the most effective and safe dose.

    The frequency and duration of this treatment will be determined based on individual response and tolerance.

  3. Step 3

    Combination treatment

    Receive a combination of glofitamab and obinutuzumab through intravenous infusion. This combination aims to enhance the treatment's effectiveness.

    The schedule for this combination treatment will be adjusted according to the response to the initial glofitamab treatment.

  4. Step 4

    Monitoring and evaluation

    Undergo regular monitoring to assess the treatment's safety and effectiveness. This includes checking vital signs, blood tests, and other necessary evaluations.

    The goal is to ensure the treatment is working as intended and to manage any side effects that may occur.

  5. Step 5

    Follow-up assessments

    Participate in follow-up assessments to evaluate the long-term effects of the treatment. This includes measuring the response to treatment and overall health status.

    These assessments help in understanding the treatment's impact over time and guide any further medical decisions.

Who can join the trial?

9 criteria

  • The patient must be willing and able to follow the study's requirements, including hospital stays and other procedures.
  • The patient must have a type of lymphoma that has come back or not responded to treatment. This includes several types like Follicular Lymphoma (FL), Marginal Zone Lymphoma, Mantle Cell Lymphoma, Diffuse Large B-cell Lymphoma (DLBCL), and others.
  • The patient must have tried at least two different treatments before, including one with a drug called anthracycline and one with a therapy targeting CD20.
  • The patient must have a life expectancy of at least 12 weeks, as judged by the doctor.
  • The patient must have a measurable disease, meaning there is a tumor that can be measured in size.
  • The patient must have a good performance status, which means they are fully active or can carry out light work.
  • The patient must have proper liver, blood, and kidney function.
  • The study is open to both male and female patients.
  • The study includes patients who may be considered vulnerable.

Who cannot join the trial?

10 criteria

  • Patients who have not experienced a return or worsening of their B-cell non-Hodgkin's lymphoma after treatment.
  • Patients who are not able to tolerate the medications being tested in the study.
  • Patients who have other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are not within the age range specified for the study.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies to the medications being tested.
  • Patients who have certain infections that could affect the study results.
  • Patients who have had a recent major surgery.
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Investigated drugs

  • Glofitamab

    is a medication being studied for its potential to treat certain types of B-cell non-Hodgkin's lymphoma, which is a type of cancer that affects the lymphatic system. In this trial, researchers are looking at how safe and effective glofitamab is when used alone or in combination with another medication. They are also trying to find the best dose to use. Glofitamab works by targeting specific proteins on the surface of cancer cells, which may help the immune system to attack and destroy these cells.

  • Obinutuzumab

    is another medication used in this trial. It is given to patients before they receive glofitamab. Obinutuzumab is an antibody that targets a protein found on the surface of certain cancer cells. By binding to this protein, obinutuzumab can help the immune system recognize and kill the cancer cells. In this study, obinutuzumab is used to prepare the body for treatment with glofitamab, potentially enhancing the overall effectiveness of the therapy.

What is already known about the treatment

Glofitamab – Glofitamab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating relapsed or refractory B-cell non-Hodgkin's lymphoma. It is a promising investigational drug in the field of oncology, with ongoing research to determine its optimal dosing and safety profile. The main therapeutic indication for glofitamab is in patients with certain types of lymphoma, including diffuse large B-cell lymphoma and follicular lymphoma. At the molecular level, glofitamab works by engaging the immune system to target and destroy cancer cells, specifically by binding to CD20 on B-cells and CD3 on T-cells, facilitating the immune-mediated killing of the cancerous B-cells. It is classified as a bispecific monoclonal antibody, a type of targeted cancer therapy.

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. Non-Hodgkin’s lymphoma encompasses a diverse group of blood cancers that vary significantly in their behavior and treatment response. The disease can progress by spreading to other parts of the lymphatic system or organs. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss. The progression and symptoms can vary widely depending on the specific subtype of B-cell non-Hodgkin’s lymphoma.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2023-505625-14-00Protocol codeNP30179Estimated enrolment625 patientsSponsorF. Hoffmann-La Roche AG

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).