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.
NCT ID: NCT05896163
Last Updated: 2025-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
24 participants
INTERVENTIONAL
2023-08-30
2026-03-31
Brief Summary
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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.
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Detailed Description
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For Phase 1b, participants must have previously received at least 2 prior systemic treatment regimen. For Phase 2, participants must have received at least 2 but no more than 4 prior systemic treatment regimens. All participants must have previously received an anti-CD20 containing regimen.
Phase 1b will assess dose-limiting toxicities of PF-07901801 when administered in combination with glofitamab, to select doses for the Phase 2 part of the study. Phase 2 will evaluate safety and efficacy to determine the recommended Phase 3 dose of PF-07901801 to be administered in combination with glofitamab.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1b
Participants will be allocated to sequential dose levels of PF-07901801, administered in combination with fixed doses of glofitamab after a dose of obinutuzumab, to select doses of PF-07901801 for further evaluation in Phase 2. Approximately 20 participants will be enrolled.
maplirpacept (PF-07901801)
Intravenous infusion
Glofitamab
Intravenous infusion
Obinutuzumab
Intravenous infusion
Phase 2
Participants will be randomized to 1 of 3 different dose levels of PF-07901801 which will be administered in combination with fixed doses of glofitamab after a dose of obinutuzumab. Approximately 50 participants will be enrolled.
maplirpacept (PF-07901801)
Intravenous infusion
Glofitamab
Intravenous infusion
Obinutuzumab
Intravenous infusion
Interventions
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maplirpacept (PF-07901801)
Intravenous infusion
Glofitamab
Intravenous infusion
Obinutuzumab
Intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Relapsed or refractory disease
* Participant is not be a candidate for or is unwilling to undergo high dose chemotherapy and subsequent stem cell transplant and/or is unable to receive chimeric antigen receptor (CAR) T-cell therapy
* Previous treatment with at least two prior lines of systemic therapy (for phase 2, at least 2 and no more than 4 prior lines of systemic therapy). Prior therapy must include an anti-CD20 antibody.
* Adequate bone marrow, hepatic and renal function
* Eastern Cooperative Oncology Group (ECOG) ≤2
Exclusion Criteria
* Prior allogeneic stem cell transplantation or autologous stem cell transplantation within 12 weeks prior to enrolment
* High Grade B-Cell Lymphoma
* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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The University of Kansas Hospital
Kansas City, Kansas, United States
University of Kansas Hospital Cambridge North Tower A
Kansas City, Kansas, United States
Allina Health Cancer Institute - Abbott Northwestern Hospital
Minneapolis, Minnesota, 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
Swedish Medical Center
Seattle, Washington, United States
Princess Alexandra Hospital
Brisbane, Queensland, Australia
Sheba Medical Center
Ramat Gan, Central District, Israel
Hadassah Medical Center
Jerusalem, Jerusalem, Israel
Rambam Health Care Campus
Haifa, Northern District, Israel
Sourasky Medical Center
Tel Aviv, TELL ABĪB, 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
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2022-502822-41-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
C4971006
Identifier Type: -
Identifier Source: org_study_id
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