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Immunomodulatory Agent

Mosunetuzumab + Glofitamab for Non-Hodgkin's Lymphoma

Phase 1
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
Presence of measurable nodal or extranodal lesions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until 90 days after the final dose of study treatment
Awards & highlights

Study Summary

This trialwill study how safe and effective mosunetuzumab and glofitamab are when combined with two drugs for treating B-cell non-Hodgkin's lymphoma.

Who is the study for?
Adults with B-cell Non-Hodgkin Lymphoma who've had at least two prior treatments can join this trial. They must have a measurable tumor, be in fair health (ECOG 0-2), and not planning to get pregnant or father a child. People can't join if they've had certain recent treatments, live vaccines, CNS lymphoma, severe allergies to monoclonal antibodies, unresolved toxicities from past treatments, significant other diseases, or are pregnant.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of mosunetuzumab or glofitamab combined with CELMoDs (CC-220 or CC-99282) for treating B-cell NHL. It will also look at how the body processes these drugs. Participants will receive one combination of these medications through IV or subcutaneous injections.See study design
What are the potential side effects?
Possible side effects include allergic reactions to the treatment components, potential organ inflammation due to immune response changes caused by monoclonal antibodies like mosunetuzumab and glofitamab, as well as general discomforts such as fatigue and digestive issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of my waking hours.
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I have tumors that can be measured.
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My lymphoma shows up on PET scans.
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I am 18 years old or older.
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I have a blood cancer that is likely to show the CD20 marker.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until 90 days after the final dose of study treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and until 90 days after the final dose of study treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Best overall response rate (ORR), defined as the proportion of participants whose best overall response is a partial response (PR) or a complete response (CR) during the study, as determined by the investigator using Lugano 2014 criteria [dose expansion]
Percentage of participants with adverse events [dose escalation]
Percentage of participants with dose-limiting toxicities (DLTs) [dose escalation]
Secondary outcome measures
Best CR rate, defined as the proportion of participants whose best overall response is a CR during the study, as determined by the investigator using Lugano 2014 criteria [all cohorts]
Best ORR (CR or PR at any time) on study as determined by the investigator using Lugano 2014 criteria [dose escalation]
Duration of response (DOR) as determined by the investigator using Lugano 2014 criteria [all cohorts]
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2Experimental Treatment5 Interventions
Participants will receive intravenous (IV) glofitamab + CC-99282.
Group II: Arm 1Experimental Treatment4 Interventions
Participants will receive subcutaneous (SC) mosunetuzumab + CC-220 or SC mosunetuzumab + CC-99282.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CC-220
2016
Completed Phase 2
~620
CC-99282
2017
Completed Phase 2
~70
Tocilizumab
2012
Completed Phase 4
~1840
Obinutuzumab
2015
Completed Phase 3
~3250

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,430 Previous Clinical Trials
1,089,289 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,611 Total Patients Enrolled

Media Library

CC-220 (Immunomodulatory Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05169515 — Phase 1
Non-Hodgkin's Lymphoma Research Study Groups: Arm 2, Arm 1
Non-Hodgkin's Lymphoma Clinical Trial 2023: CC-220 Highlights & Side Effects. Trial Name: NCT05169515 — Phase 1
CC-220 (Immunomodulatory Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05169515 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients at risk of any adverse outcomes when participating in Arm 1?

"Arm 1 was assigned a score of 1, as this is an early-stage trial with limited data concerning both safety and efficacy."

Answered by AI

Are there currently opportunities to participate in this scientific investigation?

"According to clinicaltrials.gov, this study is actively seeking participants for the trial which was posted on October 26th 2022 and modified on December 20th 2022."

Answered by AI

Has Arm 1 been a subject of any past research initiatives?

"At present, 170 studies are underway that analyze Arm 1. Of these live trials, 27 have reached the third stage of clinical testing. The majority of investigations into this drug take place in Poznan and New york; however, 6752 different sites are conducting research on this intervention."

Answered by AI

What therapeutic applications are typically associated with Arm 1?

"Arm 1 is typically prescribed to treat polyarticular juvenile idiopathic arthritis, but has also been used with success on conditions like refractory follicular lymphoma, rheumatoid arthritis, and cytokine release syndrome resulting from CAR-T cell therapy."

Answered by AI

How many individuals are taking part in the present research trial?

"Affirmative. According to the listings on clinicaltrials.gov, this medical experiment was first posted on October 26th 2022 and has been in need of participants since then. The trial is seeking 112 individuals at 1 centre for recruitment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and CC-99282 in Participants With B-Cell Non-Hodgkin Lymphoma
2022. "A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and CC-99282 in Participants With B-Cell Non-Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05169515.
~71 spots leftby Jul 2026
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