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.

Part of paid clinical trials in Kansas City, Kansas.

Sponsor
Pfizer
Study ID
NCT05896163
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • maplirpacept (PF-07901801) — DRUG
    Intravenous infusion
  • Glofitamab — DRUG
    Intravenous infusion
  • Obinutuzumab — DRUG
    Intravenous infusion

Study Details

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.

Key Dates

Start date
Aug 30, 2023
Status verified
May 2026
Primary completion
Apr 9, 2026
Completion
Apr 9, 2026

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

Phase 1b: Number of participants with Dose limiting toxicities (DLT) [ Time Frame: 21 days following first PF-07901801 dose ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of Kansas Hospital Cambridge North Tower AKansas CityKansas66160-
Barnes-Jewish Hospital Parkview TowerSt LouisMissouri63110-
Siteman Cancer CenterSt LouisMissouri63108-
Washington University School of MedicineSt LouisMissouri63110-

Find similar trials in Kansas City, KS

By research site
University of Kansas Hospital Cambridge North Tower A· Kansas City, KSBarnes-Jewish Hospital Parkview Tower· St Louis, MOSiteman Cancer Center· St Louis, MOWashington University School of Medicine· St Louis, MO

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