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NCT05896163 · ClinicalTrials.gov registry record · Phase 1
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.
A Phase 1 study of Diffuse Large B Cell Lymphoma, sponsored by Pfizer.
- Active
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 19
- Study locations
NCT05896163: Active Phase 1 study of Diffuse Large B Cell Lymphoma, sponsored by Pfizer.
NCT05896163 is a Phase 1 study of Diffuse Large B Cell Lymphoma that is active but no longer recruiting, run by Pfizer. The registered enrollment target is 24 participants, below the 218-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (89% lower). The trial reports 19 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05896163, a Phase 1 study of Diffuse Large B Cell Lymphoma, is active but no longer recruiting, sponsored by Pfizer.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 19
- Study locations
Study 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)
Primary Outcome
DLTs are a predefined set of adverse events that are at least possibly related to any or all of the investigational agents.
Conditions Studied
Interventions
- DRUG Obinutuzumab
- DRUG Glofitamab
- DRUG maplirpacept (PF-07901801)
Study Locations (19)
Missouri
- Siteman Cancer Center - St Louis
- Barnes-Jewish Hospital Parkview Tower - St Louis
- Barnes-Jewish Hospital - St Louis
- Washington University School of Medicine - St Louis
Other
- National Hospital Organization Kyushu Cancer Center - Fukuoka
- National Taiwan University Hospital - Taipei
- Koo Foundation Sun Yat-Sen Cancer Center - Taipei
Kansas
- The University of Kansas Hospital - Kansas City
- University of Kansas Hospital Cambridge North Tower A - Kansas City
Washington
- Swedish Cancer Institute - Seattle
- Swedish Medical Center - Seattle
Minnesota
- Allina Health Cancer Institute - Abbott Northwestern Hospital - Minneapolis
Queensland
- Princess Alexandra Hospital - Brisbane
Central District
- Sheba Medical Center - Ramat Gan
Jerusalem
- Hadassah Medical Center - Jerusalem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2023-08-30 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 1 |
What the registry record for NCT05896163 still lists
NCT05896163 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 218-participant average among 114 other Diffuse Large B Cell Lymphoma trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Diffuse Large B Cell Lymphoma appearing as the primary indexed condition, and to 3 interventions - of which Obinutuzumab is the first listed.
NCT05896163 lists 19 locations in 12 states (Missouri, Other, Kansas).
Frequently Asked Questions
What is clinical trial NCT05896163 about?
NCT05896163 is a clinical study titled "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.". 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 ...
What is the current status of trial NCT05896163?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2023-08-30. Estimated completion is 2026-03-31.
What conditions does trial NCT05896163 study?
This clinical trial studies the following conditions: Diffuse Large B Cell Lymphoma.
What interventions are being tested in trial NCT05896163?
The interventions under investigation include: Obinutuzumab (DRUG), Glofitamab (DRUG), maplirpacept (PF-07901801) (DRUG).
Who is sponsoring clinical trial NCT05896163?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05896163 being conducted?
This trial has 19 study locations across Kansas, Minnesota, Missouri, Washington, Queensland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05896163's enrollment target sits among peer trials
24 89th of 114 higher than 23 of 114 other Diffuse Large B Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diffuse Large B Cell Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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