Maplirpacept + Tafasitamab + Lenalidomide for Non-Hodgkin's Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a combination of three medicines—maplirpacept, tafasitamab, and lenalidomide—to treat diffuse large B-cell lymphoma (DLBCL), a type of non-Hodgkin's lymphoma. It targets patients whose lymphoma has returned after previous treatments or hasn't responded to them. Participants will receive these medications either by IV infusion or orally over 28-day cycles. The trial seeks individuals with DLBCL who have had at least one prior treatment and are unable or unwilling to undergo certain intensive therapies, such as stem cell transplants or CAR-T cell therapy. The goal is to determine a safe and effective dose of maplirpacept when used with the other two drugs. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new combination therapy.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that tafasitamab and lenalidomide are generally well-tolerated by patients. Tafasitamab has been used safely in other treatments for diffuse large B-cell lymphoma, with some patients experiencing mild to moderate side effects like tiredness or low blood cell counts. Lenalidomide is also commonly used and can cause side effects such as fatigue, low blood counts, or stomach upset, but these can be managed with proper care.
Maplirpacept (PF-07901801) is newer, so less information is available. The current study is in its early stages, and researchers are still determining how well people can handle different doses. This phase is crucial for assessing safety, and participants' experiences will help identify the right dose.
Overall, while tafasitamab and lenalidomide have established safety records, maplirpacept's safety is still under close observation. Participants might experience side effects, but researchers are committed to ensuring the combination is as safe as possible.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination treatment of maplirpacept (PF-07901801), tafasitamab, and lenalidomide for Non-Hodgkin's Lymphoma because it introduces a novel approach. Unlike standard treatments that often rely on chemotherapy, this combination includes maplirpacept, a unique agent that targets specific pathways involved in tumor growth. Tafasitamab, an antibody, works by engaging the immune system to attack cancer cells, while lenalidomide enhances this immune response. Together, these treatments offer the potential for a more targeted and effective option with possibly fewer side effects than traditional therapies.
What evidence suggests that this trial's treatments could be effective for non-Hodgkin's lymphoma?
Earlier studies showed that combining tafasitamab and lenalidomide produced promising results for treating diffuse large B-cell lymphoma (DLBCL). Lenalidomide increased the cancer-fighting effects of tafasitamab by 3 to 5 times. Initial research on maplirpacept (PF-07901801) alone suggested it might benefit people with lymphomas that have returned or are not responding to treatment. In this trial, researchers are examining how these three drugs work together. Participants will receive varying doses of maplirpacept alongside standard doses of tafasitamab and lenalidomide. The goal is to enhance the immune system's ability to fight cancer cells.13456
Who Is on the Research Team?
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Are You a Good Fit for This Trial?
This trial is for people with a type of cancer called diffuse large B-cell lymphoma that has either come back or didn't respond to treatment. They should have tried at least one other therapy but can't or don't want to do certain stem cell transplants or CAR-T therapy. Participants need to provide a tumor sample and have good enough bone marrow, liver, and kidney function.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive maplirpacept (PF-07901801), tafasitamab, and lenalidomide in 28-day cycles. Maplirpacept is given weekly for the first three cycles and then every two weeks. Tafasitamab is administered on Days 1, 4, 8, 15, and 22 in cycle 1, weekly in cycles 2 and 3, and then every 2 weeks in cycle 4 and beyond. Lenalidomide is taken daily for Days 1 to 21 of each 28-day cycle for the first 12 cycles.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may continue to take maplirpacept (PF-07901801) and tafasitamab until their lymphoma is no longer responding.
What Are the Treatments Tested in This Trial?
Interventions
- Lenalidomide
- PF-07901801
- Tafasitamab
Lenalidomide is already approved in European Union, United States for the following indications:
- Multiple myeloma
- Myelodysplastic syndromes
- Mantle cell lymphoma
- Follicular lymphoma
- Marginal zone lymphoma
- Multiple myeloma
- Myelodysplastic syndromes
- Mantle cell lymphoma
- Follicular lymphoma
- Marginal zone lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University
Incyte Corporation
Industry Sponsor
Steven Stein
Incyte Corporation
Chief Medical Officer since 2015
MD from University of Witwatersrand
Hervé Hoppenot
Incyte Corporation
Chief Executive Officer since 2014
MBA from ESSEC Business School
MorphoSys AG
Industry Sponsor