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.

NCT05896163 | Terminated Phase 1 FDA Drug

• 2 other identifiers: C49710062022-502822-41-00
• Study Type: interventional
• Target: 40
• Locations: 4 countries
• Sites: 10

Brief 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.

Conditions

Diffuse Large B-Cell Lymphoma

Keywords

DLBCL; Lymphoma; Relapsed; Refractory; CD20; CD3; CD47; Glofitamab; Obinutuzumab; Maplirpacept

Outcome Measures

Primary Outcomes (2)

• Phase 1b: Number of participants with Dose limiting toxicities (DLT)

  DLTs are a predefined set of adverse events that are at least possibly related to any or all of the investigational agents.

  21 days following first PF-07901801 dose

• Phase 2: Objective Response (OR)

  OR defined as proportion of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Lugano Response Classification Criteria 2014.

  Time from the date of first dose of study intervention until the first documentation of disease progression, death, or start of new anticancer therapy (assessed up to approximately 24 months)

Secondary Outcomes (10)

• Phase 1b and Phase 2: Frequency of adverse events (AE)

  Time from the date of first dose of study intervention through 28 days after last dose of PF-07901801 or 90 days after last dose of glofitamab or obinutuzumab (assessed up to approximately 24 months)

• Phase 1b and Phase 2: Frequency of clinical laboratory abnormalities

  Time from the date of first dose of study intervention through 28 days after last dose of PF-07901801 or 90 days after last dose of glofitamab or obinutuzumab (assessed up to approximately 24 months)

• Phase 1b: Objective Response (OR)

  Time from the date of first dose of study intervention until the first documentation of disease progression, death, or start of new anticancer therapy (assessed up to approximately 24 months)

• Phase 1b and Phase 2: Duration of Response (DoR)

  Time from the date of first dose of study intervention until the first documentation of disease progression, death, or start of new anticancer therapy (assessed up to approximately 24 months)

• Phase 1b and Phase 2: Complete Response (CR)

  Time from the date of first dose of study intervention until the first documentation of disease progression, death, or start of new anticancer therapy (assessed up to approximately 24 months)

Study Arms (2)

Phase 1b

EXPERIMENTAL

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.

Drug: maplirpacept (PF-07901801); Drug: Glofitamab; Drug: Obinutuzumab

Phase 2

EXPERIMENTAL

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.

Drug: maplirpacept (PF-07901801); Drug: Glofitamab; Drug: Obinutuzumab

Interventions

Obinutuzumab DRUG

Intravenous infusion

Also known as: Gazyva

Phase 1b; Phase 2

maplirpacept (PF-07901801) DRUG

Intravenous infusion

Phase 1b; Phase 2

Glofitamab DRUG

Intravenous infusion

Also known as: Columvi

Phase 1b; Phase 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Prior treatment with anti-CD47 and/or prior glofitamab or anti-CD20 x CD3 containing regimen. Refractoriness to an obinutuzumab monotherapy containing regimen.
• 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.

Sponsors & Collaborators

• Pfizer: lead
• Hoffmann-La Roche: collaborator

Study Sites (10)

University of Kansas Hospital Cambridge North Tower A

Kansas City, Kansas, 66160, United States

Location

Siteman Cancer Center

St Louis, Missouri, 63108, United States

Location

Barnes-Jewish Hospital Parkview Tower

St Louis, Missouri, 63110, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Sheba Medical Center

Ramat Gan, Central District, 5262100, Israel

Location

Rambam Health Care Campus

Haifa, Northern District, 3109601, Israel

Location

Sourasky Medical Center

Tel Aviv, TELL ABĪB, 6423906, Israel

Location

Shizuoka Cancer Center

Nagaizumi-cho, Shizuoka, 411-8777, Japan

Location

National Hospital Organization Kyushu Cancer Center

Fukuoka, 811-1395, Japan

Location

Gazi University I lcalth Research and Annlica1ion Cenlcr Gazi Hospilal

Ankara, 06560, Turkey (Türkiye)

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse; Lymphoma; Recurrence

Interventions

glofitamab; obinutuzumab

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label/randomized

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: June 9, 2023
• Study Start: August 30, 2023
• Primary Completion: April 9, 2026
• Study Completion: April 9, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (4); IL (3); JP (2); TU (1)