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A Study to Learn About the Effects of Two Study Medicines (Maplirpacept [PF-07901801] And Glofitamab) When Given Together In People With Relapsed Or Refractory Diffuse Large B Cell Lymphoma.
Sponsor: Pfizer
Summary
The purpose of this study is to learn about the effects of two study medicines (maplirpacept \[PF-07901801\] and glofitamab) when given together for the treatment of diffuse large B-cell lymphoma (DLBCL) that is relapsed or is refractory. Relapsed means has returned after last treatment. Refractory means that it has not responded to last treatment. The two study medicines are given after a single dose of obinutuzumab which is the third study medicine. DLBCL is a type of non-Hodgkin lymphoma (NHL). NHL is a cancer of the lymphatic system. It develops when the body makes abnormal B lymphocytes. These lymphocytes are a type of white blood cell that normally help to fight infections. This study is seeking adult participants who: * Have histologically confirmed diagnosis of DLBCL * Have received at least two first lines of treatment for NHL. * Are unable or unwilling to undergo a stem cell transplant or CAR-T cell therapy. Stem cell transplant is a procedure in which a patient receives healthy blood-forming cells to replace their own stem cells that have been destroyed by treatment. A CAR-T therapy is a type of treatment in which a patient's T cells are changed in the laboratory so they will attack cancer cells. Everyone in this study will receive all three medicines at the study site by intravenous (IV) infusion which is given directly into a vein. The two study medicines (maplirpacept \[PF-07901801\] and glofitamab) will be given in 21-day cycles. At Cycle 0, participants will receive a single dose of obinutuzumab pre-treatment followed by two step-up doses of glofitamab. The combination of maplirpacept (PF-07901801) with glofitamab full dose will be administered for the first time at Cycle 1 Day 1. Maplirpacept (PF-07901801) will be given weekly for the first three cycles and then every three weeks. Glofitamab will be given every 3 weeks for approximately 9 months. Thereafter participants will continue to receive maplirpacept alone. Maplirpacept (PF-07901801) will be given at different doses to different participants. Everyone taking part will receive the same fixed doses of glofitamab and obinutuzumab studied in patients with DLBCL. The study will compare the experiences of people receiving different doses of maplirpacept (PF-07901801). This will help to determine what dose is safe and effective when given with the other 2 study medicines.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2023-08-30
Completion Date
2026-04-06
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
maplirpacept (PF-07901801)
Intravenous infusion
Glofitamab
Intravenous infusion
Obinutuzumab
Intravenous infusion
Locations (18)
The University of Kansas Hospital
Kansas City, Kansas, United States
University of Kansas Hospital Cambridge North Tower A
Kansas City, Kansas, United States
Siteman Cancer Center
St Louis, Missouri, United States
Barnes-Jewish Hospital Parkview Tower
St Louis, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Swedish Cancer Institute
Seattle, Washington, United States
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Sheba Medical Center
Ramat Gan, Central District, Israel
Rambam Health Care Campus
Haifa, Northern District, Israel
Sourasky Medical Center
Tel Aviv, TELL ABĪB, Israel
Hadassah Medical Center
Jerusalem, Israel
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Nagoya, Aichi-ken, Japan
Shizuoka Cancer Center
Nagaizumi-cho, Shizuoka, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, Japan
National Taiwan University Hospital
Taipei, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, Taiwan
Gazi University I lcalth Research and Annlica1ion Cenlcr Gazi Hospilal
Ankara, Turkey (Türkiye)