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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


Description

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

Trial Eligibility

Key Inclusion Criteria: * 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 Key Exclusion Criteria: * 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.

Study Info

Organization

Pfizer


Primary Outcome

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


Outcome Timeframe 21 days following first PF-07901801 dose

NCTID NCT05896163

Phases PHASE1,PHASE2

Primary Purpose TREATMENT

Start Date 2023-08-30

Completion Date 2026-10-26

Enrollment Target 70

Interventions

DRUG maplirpacept (PF-07901801)

DRUG Glofitamab

DRUG Obinutuzumab

Locations Recruiting

The University of Kansas Cancer Center ,Investigational Drug Services

United States, Kansas, Fairway


The University of Kansas Cancer Center ,Investigational Drug Services

United States, Kansas, Fairway


The University of Kansas Clinical Research Center

United States, Kansas, Fairway


The University of Kansas Hospital

United States, Kansas, Kansas City


University of Kansas Hospital Cambridge North Tower A

United States, Kansas, Kansas City


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