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ACTIVE NOT RECRUITING
NCT05896163
PHASE1/PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

maplirpacept (PF-07901801)

Intravenous infusion

DRUG

Glofitamab

Intravenous infusion

DRUG

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)