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Monoclonal Antibodies

Combination Therapy for Non-Hodgkin's Lymphoma

Phase 1 & 2

Recruiting

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up time from the date of first dose of study intervention until pd, or death due to any cause, whichever occurs first (assessed up to approximately 24 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial will research the effectiveness of a combination of 3 medicines (maplirpacept, glofitamab, obinutuzumab) for non-Hodgkin lymphoma, which is a cancer of the lymphatic system. Different doses of maplirpacept will be studied.

Who is the study for?

Adults with a confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL) that has returned or hasn't responded to treatment, who have tried at least one therapy including an anti-CD20 antibody but can't or won't get stem cell or CAR-T cell therapy. They should be in good enough health as measured by specific medical standards.

What is being tested?

The trial is testing the combination of two drugs, maplirpacept and glofitamab, after an initial dose of obinutuzumab for relapsed/refractory DLBCL. Participants will receive these medications through IV infusions over several cycles to determine the safest and most effective dosage.

What are the potential side effects?

Potential side effects may include reactions at the infusion site, changes in blood counts leading to increased infection risk or bleeding problems, liver and kidney function alterations, fatigue, fever, and potential allergic responses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time from the date of first dose of study intervention until pd, or death due to any cause, whichever occurs first (assessed up to approximately 24 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time from the date of first dose of study intervention until pd, or death due to any cause, whichever occurs first (assessed up to approximately 24 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and time from the date of first dose of study intervention until pd, or death due to any cause, whichever occurs first (assessed up to approximately 24 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Phase 2: Objective Response (OR)

Secondary study objectives

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

Phase 1b and Phase 2: Duration of Complete Response (DoCR)

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

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase 2Experimental Treatment3 Interventions

Participants will be randomized to 1 of 2 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 (25 per dose).

Group II: Phase 1bExperimental Treatment3 Interventions

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 two doses of PF-07901801 for further evaluation in Phase 2. Approximately 20 participants will be enrolled.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Glofitamab

2021

Completed Phase 1

~60

maplirpacept (PF-07901801)

2022

Completed Phase 1

~10