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 study about?

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.

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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country
Hopitaux Universitaires Pitie Salpetriere	Paris	France
Klinikum der Stadt Ludwigshafen am Rhein gGmbH	Ludwigshafen Am Rhein	Germany
Hospital Universitario Ramon Y Cajal	Madrid	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Centre Hospitalier De La Cote Basque	Bayonne	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Hmnnzexv Uhkwllxscilbs Mkyjeqt Di Vlclyhubhb	Santander	Spain
Inbstgsn Cdcgbn Degkkbqdehcvukjiz	L'hospitalet De Llobregat	Spain
Vtnldisj Njqyzake fceu Gvbhutjtwn Gekk	Berlin	Germany
Iqjuvagc Btccbmsq	Bordeaux	France
Amygnppzlp Pltedfbt Hpbnziao Dy Pfhzb	Paris	France
Hdrcnrka Dk Lk Ssqfz Cppx I Sqhb Pzo	Barcelona	Spain
Mzcbvhzqzdekfrfdoetmwjybli Hchbgvkfgikkhfvw	Halle (Saale)	Germany
Hexisrku Vfan dlrwcsfn	Barcelona	Spain
Iraurnnb Putvhzsrtfxjywi Cgfeqk Cysivq	Marseille	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.07.2025
Germany	Not recruiting	01.07.2025
Spain	Not recruiting	01.07.2025

Trial locations

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.

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 ID:

2022-502822-41-00

Protocol code:

C4971006

NCT ID:

NCT05896163

Trial Phase:

Human Pharmacology (Phase I) – Other

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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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?