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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

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 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

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
Obinutuzumab
2014
Completed Phase 3
~3470

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,627 Previous Clinical Trials
14,284,862 Total Patients Enrolled
Hoffmann-La RocheIndustry Sponsor
2,445 Previous Clinical Trials
1,093,440 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,519 Previous Clinical Trials
11,459,348 Total Patients Enrolled

Media Library

Glofitamab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05896163 — Phase 1 & 2
Non-Hodgkin's Lymphoma Research Study Groups: Phase 2, Phase 1b
Non-Hodgkin's Lymphoma Clinical Trial 2023: Glofitamab Highlights & Side Effects. Trial Name: NCT05896163 — Phase 1 & 2
Glofitamab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05896163 — Phase 1 & 2
~47 spots leftby Oct 2026
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