Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

C4971006: A PHASE 1b/2, OPEN-LABEL STUDY OF PF-07901801 IN COMBINATION WITH GLOFITAMAB AFTER A FIXED, SINGLE DOSE OF OBINUTUZUMAB IN PARTICIPANTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE B CELL LYMPHOMA NOT ELIGIBLE FOR STEM CELL TRANSPLANTATION

This research study is for adults with Diffuse Large B Cell Lymphoma, a type of blood cancer, where previous treatments haven't worked or the cancer has returned. Participants are not able to have a stem cell transplant. The study is testing a new combination of medicines: Columvi, Gazyvaro, and Maplirpacept. It's an 'open-label' study, meaning everyone knows what medicine they are getting. We want to find out how safe these medicines are together and how effectively they shrink or control the cancer. The study is divided into two parts: one to find the right dose and check safety, and another to see how many people respond to the treatment.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Pfizer Inc.

Enrolment target

Start

30 Apr 2025

Relapsed/Refractory Diffuse Large B Cell Lymphoma

What is this study about?

This study is about a type of blood cancer called Diffuse Large B Cell Lymphoma (DLBCL) that has either come back after treatment or hasn't responded well to previous treatments. It's for people who, for various reasons, cannot have a stem cell transplant, which is another common treatment option for this condition. The study is testing a new way of treating this cancer by combining three different medicines: Columvi, Gazyvaro, and Maplirpacept.

The main goal of the first part of the study (Phase 1b) is to carefully look at the safety of this new combination of medicines. Researchers want to make sure the combination is well-tolerated and to find out what possible side effects might occur. In the second part of the study (Phase 2), the goal is to see how many people respond to the treatment, meaning their cancer shrinks or stops growing. Researchers will also continue to monitor for side effects and how long any benefits from the treatment last.

By running this study, doctors hope to find a new and effective way to treat DLBCL for people who currently have limited options. The results will help us understand if this new combination of medicines could be a helpful treatment for patients in the future.

Key takeaways

This study tests new medicines for a type of blood cancer (DLBCL) that has returned or is hard to treat.
It's for adults who cannot have a stem cell transplant.
The main goals are to check the safety and how well the new combination works.
You'll get three study medicines: Columvi, Gazyvaro, and Maplirpacept.
Participation involves regular hospital visits for infusions and check-ups.

Who may be eligible?

This study is for adults aged 18 and over, of any gender. To join, you must have Diffuse Large B Cell Lymphoma that has either returned after previous treatment or hasn't responded to treatment.

Importantly, you must also not be eligible for a stem cell transplant. This means that a stem cell transplant, which is sometimes used for this type of cancer, isn't a suitable option for you based on medical reasons.

There will be other detailed medical criteria that your doctor will check to see if this study is right for you. These criteria are in place to ensure your safety and that the study results are clear and accurate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with Diffuse Large B Cell Lymphoma?
Has your lymphoma come back or not responded to previous treatments?
Have your doctors told you that you are not suitable for a stem cell transplant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the study medicines: Columvi, Gazyvaro, and Maplirpacept, given as infusions (drips) into your vein. The study involves regular visits to the hospital or clinic for these infusions, as well as for check-ups, blood tests, and scans to monitor your health and how well the treatment is working. These assessments help the study team understand the effects of the medicines.

The specific schedule of visits and tests will be explained in detail by the study team. You will likely have more frequent visits at the beginning of the study, which may become less frequent over time if the treatment is right for you. The total duration of your participation will vary, depending on how you respond to the treatment and your overall health, but it could last for many months.

Throughout the study, you will be closely monitored for any side effects or changes in your health. You will also have follow-up assessments even after you stop taking the study medicines, to track your long-term health and any lasting effects.

Potential risks and benefits

Participating in any clinical study comes with potential benefits and risks. A potential benefit of joining this study is that you might receive a new treatment that could help control your cancer, especially if other treatments haven't worked. However, there's no guarantee the treatment will work for you. Potential risks include experiencing side effects from the study medicines, which can range from mild to severe, or the treatment not being effective. The study team will explain all known side effects in detail. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain
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Unverified
France
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Unverified
Germany

Common questions

What is Diffuse Large B Cell Lymphoma?

It's a fast-growing type of cancer that affects white blood cells called lymphocytes. These cells are part of your immune system.

What does 'relapsed/refractory' mean?

It means the cancer has come back after treatment (relapsed) or hasn't responded to treatment (refractory).

What does 'open-label' mean for me?

It means that both you and your study doctor will know which specific medicines you are receiving during the study.

What are 'side effects' and will I get them?

Side effects are unwanted reactions to medicines. Not everyone gets them, but the study team will monitor you closely and explain potential ones.

Will I have to pay to be in the study?

No, you will not have to pay for the study medicines or study-related tests. Travel expenses may be covered, but you should ask the study team about this.