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Study on the Effects of Maplirpacept, Glofitamab, and Obinutuzumab in Patients with Relapsed or Refractory Diffuse Large B Cell Lymphoma Not Eligible for Stem Cell Transplant

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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 Diffuse Large B Cell Lymphoma (DLBCL), which has returned or not responded to previous treatments. The study involves testing the effects of two study medicines, Maplirpacept (also known by its code name PF-07901801) and Glofitamab, when given together. Before receiving these two medicines, participants will receive a single dose of another medicine called Obinutuzumab.

The purpose of the study is to learn about the safety and effects of these medicines when used in combination. The study will be conducted in two phases. In the first phase, the focus will be on understanding any side effects and determining the best doses of Maplirpacept to use in the next phase. In the second phase, the study will look at how well the combination of Maplirpacept and Glofitamab works in treating the cancer.

Participants in the study will receive the medicines through an intravenous infusion, which means the medicine is given directly into a vein. The study will help researchers understand more about the potential benefits and risks of these medicines for people with relapsed or refractory DLBCL who are not eligible for stem cell transplantation.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment

    Upon joining the study, you will receive a single dose of obinutuzumab. This medication is given through an intravenous (IV) infusion, which means it is delivered directly into your bloodstream through a vein. This step is designed to prepare your body for the next phase of treatment.

  2. Step 2

    Combination therapy

    After the initial treatment, you will begin receiving a combination of two study medications: glofitamab and maplirpacept. Both medications are administered through IV infusion. The specific dosage and frequency will be determined by the study team based on your individual response and the phase of the trial you are in.

    The goal of this combination therapy is to assess the safety and effectiveness of these medications when used together in treating your condition.

  3. Step 3

    Monitoring and assessments

    Throughout the trial, you will undergo regular monitoring and assessments. This includes physical exams, blood tests, and imaging studies to evaluate how your body is responding to the treatment.

    The study team will closely monitor for any side effects or adverse reactions to the medications. It is important to report any new symptoms or changes in your health to the study team immediately.

  4. Step 4

    Follow-up

    After completing the treatment phase, you will enter a follow-up period. During this time, the study team will continue to monitor your health and the long-term effects of the treatment.

    Follow-up visits may include additional tests and assessments to ensure your well-being and to gather data on the effectiveness of the treatment over time.

Who can join the trial?

6 criteria

  • Adults with a confirmed diagnosis of Diffuse Large B Cell Lymphoma (DLBCL) that has come back or not responded to treatment.
  • The participant is not a candidate for, or does not want to undergo, high-dose chemotherapy and a subsequent autologous stem cell transplant (a procedure where a patient's own stem cells are used to replace damaged or destroyed bone marrow) or cannot receive approved chimeric antigen receptor T-cell therapy (CAR-T) (a type of treatment in which a patient's T cells are changed in the laboratory so they will attack cancer cells).
  • The participant must have at least one area of cancer that can be measured using a PET scan (a type of imaging test) according to the Lugano 2014 classification.
  • The participant must have had at least two different treatments for their cancer before (for Phase 2: at least two but no more than four previous treatments). One of these treatments must have included an anti-CD20 medication (a type of drug that targets specific proteins on cancer cells).
  • The participant must have adequate blood, liver, and kidney function.
  • The participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, which means they are fully active, able to carry out light work, or capable of all self-care but unable to carry out any work activities.

Who cannot join the trial?

3 criteria

  • Patients who have not been diagnosed with Relapsed/Refractory Diffuse Large B Cell Lymphoma cannot participate. This is a type of cancer that affects the lymphatic system.
  • Patients who are not adults are excluded. This means only individuals who are 18 years or older can participate.
  • Patients who are part of a vulnerable population are not eligible. This refers to groups who may have additional risks or need special protection in research.
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Investigated drugs

  • PF-07901801

    is an experimental medication being tested in this clinical trial. It is being studied to see how safe it is and how well it works when used with other treatments for a type of cancer called diffuse large B cell lymphoma, which has come back or has not responded to previous treatments. This medication is being tested to find the best dose that can be used in future studies.

  • Glofitamab

    is a medication that is part of this clinical trial. It is designed to help the body's immune system find and attack cancer cells. In this study, it is used in combination with other treatments to see if it can help treat diffuse large B cell lymphoma that has returned or is resistant to other treatments.

  • Obinutuzumab

    is a medication given as a single dose at the beginning of the trial. It is used to prepare the body for the other treatments in the study. Obinutuzumab works by targeting specific cells in the immune system, which can help the other medications work more effectively against the cancer.

What is already known about the treatment

  • PF-07901801

    This medication is administered in combination with other drugs for treating a type of cancer called relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). It is currently being studied in clinical trials to determine its safety and effectiveness. The main goal is to see how well it works when used with other medications like glofitamab and obinutuzumab. PF-07901801 works by targeting specific molecules on cancer cells, helping the immune system to recognize and destroy these cells. It is classified as an investigational drug, meaning it is still being tested and is not yet approved for general use.

  • Glofitamab

    This medication is given to patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL) as part of a combination treatment. It is currently under investigation in clinical trials to evaluate its safety and how well it works when used with PF-07901801 and obinutuzumab. Glofitamab helps the immune system to attack cancer cells by binding to specific proteins on the surface of these cells. It is considered an investigational drug, which means it is still being studied and is not yet widely available.

  • Obinutuzumab

    This medication is used as a single, fixed dose in combination with other drugs for treating relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). It is part of a clinical trial to assess its role in enhancing the effectiveness of PF-07901801 and glofitamab. Obinutuzumab works by targeting a protein on the surface of cancer cells, helping the immune system to destroy them. It is a monoclonal antibody, a type of drug designed to specifically target certain cells in the body.

Investigated diseases

Relapsed/Refractory Diffuse Large B Cell Lymphoma – This is a type of non-Hodgkin lymphoma that affects B cells, which are a type of white blood cell. It occurs when the disease returns after treatment (relapsed) or does not respond to treatment (refractory). The disease typically starts in the lymph nodes and can spread to other parts of the body, including the bone marrow, spleen, and liver. As it progresses, it can cause symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. The disease is characterized by the rapid growth of large B cells, which can form tumors in various parts of the body. The progression can vary, with some cases advancing quickly while others may develop more slowly.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2022-502822-41-00Protocol codeC4971006Estimated enrolment90 patientsSponsorPfizer Inc.

sourced from the EU Clinical Trials Register and site verification

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