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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
Must not have
Prior therapy with cereblon (CRBN)-modulating drug within 4 weeks
Current or past history of central nervous system (CNS) lymphoma or leptomeningeal infiltration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing new drug combinations to help the immune system fight B-cell Non-Hodgkin Lymphoma. The drugs work by helping the body recognize and attack cancer cells more effectively. A combination of two drugs has shown promise in treating non-Hodgkin lymphoma by enabling the immune system to recognize and attack cancer cells.

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't taken any CRBN-modulating drugs in the last 4 weeks.
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I have or had brain lymphoma or cancer spread to the lining of my brain and spinal cord.
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I have no lasting side effects from previous treatments.
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I have had a major surgery or significant injury recently.
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I have received specific treatments before.
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I cannot swallow pills or have ongoing diarrhea or issues absorbing food.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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: Arm 2Experimental Treatment4 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
2020
Completed Phase 2
~80
Tocilizumab
2012
Completed Phase 4
~1840
Obinutuzumab
2014
Completed Phase 3
~3470

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Non-Hodgkin's Lymphoma (NHL) include bispecific antibodies and CELMoDs. Bispecific antibodies like Mosunetuzumab or Glofitamab target CD20 on B-cells and CD3 on T-cells, facilitating T-cell-mediated killing of B-cells. CELMoDs, such as CC-220 or CC-99282, modulate the cereblon E3 ligase complex, leading to the degradation of proteins essential for lymphoma cell survival and proliferation. These targeted therapies are significant for NHL patients as they enhance the immune system's ability to selectively destroy cancer cells, potentially reducing the side effects compared to traditional chemotherapy.

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,459 Previous Clinical Trials
1,098,104 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,228 Previous Clinical Trials
896,538 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
~52 spots leftby Jul 2026