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

Status: Recruiting
Location: See all (27) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically confirmed diagnosis of DLBCL

• 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

Locations
United States
Kansas
The University of Kansas Cancer Center ,Investigational Drug Services
RECRUITING
Fairway
The University of Kansas Clinical Research Center
RECRUITING
Fairway
The University of Kansas Hospital
RECRUITING
Kansas City
University of Kansas Hospital Cambridge North Tower A
RECRUITING
Kansas City
Minnesota
Allina Health Cancer Institute - Abbott Northwestern Hospital
NOT_YET_RECRUITING
Minneapolis
Missouri
Barnes-Jewish Hospital
RECRUITING
St Louis
Barnes-Jewish Hospital Parkview Tower
RECRUITING
St Louis
Siteman Cancer Center
RECRUITING
St Louis
Washington University School of Medicine
RECRUITING
St Louis
Washington
Swedish Cancer Institute
RECRUITING
Seattle
Swedish Medical Center
RECRUITING
Seattle
Other Locations
Australia
Princess Alexandra Hospital
RECRUITING
Brisbane
Townsville Hospital and Health Service
NOT_YET_RECRUITING
Douglas
St Vincent's Hospital Melbourne
NOT_YET_RECRUITING
Fitzroy
Epworth Freemasons
NOT_YET_RECRUITING
Melbourne
Slade Pharmacy
NOT_YET_RECRUITING
Richmond
Townsville University Hospital
NOT_YET_RECRUITING
Townsville
Israel
Rambam Health Care Campus
RECRUITING
Haifa
Hadassah Medical Center
RECRUITING
Jerusalem
Sheba Medical Center
RECRUITING
Ramat Gan
Sourasky Medical Center
NOT_YET_RECRUITING
Tel Aviv
Japan
National Hospital Organization Kyushu Cancer Center
RECRUITING
Fukuoka
Shizuoka Cancer Center
RECRUITING
Nagaizumi-cho
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
RECRUITING
Nagoya
Taiwan
China Medical University Hospital
NOT_YET_RECRUITING
Taichung
Koo Foundation Sun Yat-Sen Cancer Center
RECRUITING
Taipei
National Taiwan University Hospital
RECRUITING
Taipei
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2023-08-30
Estimated Completion Date: 2028-09-27
Participants
Target number of participants: 70
Treatments
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.
Sponsors
Collaborators: Hoffmann-La Roche
Leads: Pfizer

This content was sourced from clinicaltrials.gov

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