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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
Study 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.Check my eligibility
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.See study design
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1b: Number of participants with Dose limiting toxicities (DLT)
Phase 2: Objective Response (OR)
Secondary outcome measures
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 moreTrial 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
Obinutuzumab
2015
Completed Phase 3
~3250
Glofitamab
2021
Completed Phase 1
~60
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,573 Previous Clinical Trials
10,923,281 Total Patients Enrolled
Hoffmann-La RocheIndustry Sponsor
2,432 Previous Clinical Trials
1,089,816 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,479 Previous Clinical Trials
8,099,499 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I currently have an active infection.I've had 1-2 treatments for my condition, including one with an anti-CD20 antibody.My liver, kidneys, and bone marrow are functioning well.I have been treated with anti-CD47, glofitamab, or anti-CD20 x CD3 drugs and did not respond to obinutuzumab alone.I can take care of myself and am up and about more than 50% of my waking hours.My diagnosis is diffuse large B-cell lymphoma.I had a stem cell transplant less than 12 weeks ago.I have been diagnosed with high-grade B-cell lymphoma.My condition has returned or didn't respond to treatment.I cannot or do not want to undergo high dose chemotherapy and stem cell transplant, and I cannot receive CAR T-cell therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 2
- Group 2: Phase 1b
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available vacancies in this trial for participants?
"According to clinicaltrials.gov, the trial that was initially posted on August 3rd 2023 is no longer in need of volunteers. As of July 28th 2023, there are a total 1767 medical studies actively recruiting participants for their trials."
Answered by AI
How many centers are involved in the oversight of this trial?
"Currently, the trial is being run in 4 distinct locations: Nagoya, Nagaizumi-cho, Sunto-gun and Fukuoka. It would be prudent for prospective patients to select a nearby site to reduce their travel commitments."
Answered by AI
What goals are being sought after through this research endeavor?
"This clinical trial's primary end-goal is an Objective Response (OR) achieved within a 21 day period after the first dose of PF-07901801. Secondary objectives include evaluating the proportion of participants with CR/PR according to Lugano Response Classification Criteria 2014, measuring immunogenicity against both PF-07901801 and glofitamab."
Answered by AI
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