What side effects are associated with this type of intervention?

Common side effects of bispecific antibodies like Mosunetuzumab and Glofitamab in treating Non-Hodgkin's Lymphoma include cytokine release syndrome (CRS), serious infections, prolonged cytopenias, and neurologic toxicities. CELMoDs, such as CC-220 and CC-99282, are associated with hematologic toxicities like neutropenia and lymphocytopenia, which can increase infection risk. Combining these treatments may heighten these risks, requiring vigilant monitoring and supportive care.

What prior FDA approvals exist?

The FDA has approved several treatments for Non-Hodgkin's Lymphoma, including bispecific antibodies and CAR-T cell therapies. Bispecific antibodies like mosunetuzumab and glofitamab, which target CD20 and CD3, have shown promise in clinical trials for relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Additionally, CAR-T cell therapies such as axicabtagene ciloleucel and tisagenlecleucel, which target CD19, have been approved for relapsed or refractory DLBCL. These therapies represent significant advancements in the treatment of NHL, offering new options for patients who have not responded to traditional treatments.

What other types of research exist?

Promising novel alternatives for NHL treatment in 2024 include: 1) CAR T-cell therapies such as Axicabtagene Ciloleucel and Lisocabtagene Maraleucel, which have shown significant efficacy in relapsed/refractory NHL. 2) Bispecific T-cell engagers (BiTEs) like Blinatumomab, which target CD19 and CD3. 3) Antibody-drug conjugates (ADCs) such as Polatuzumab Vedotin, which targets CD79b. These therapies have demonstrated promising results in clinical trials and may offer effective alternatives for NHL patients.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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-99282

2020

Completed Phase 2

~80

CC-220

2016

Completed Phase 2

~620

Tocilizumab

2012

Completed Phase 4

~1840

Obinutuzumab

2014

Completed Phase 3

~3470

0 / 11Eligibility criteria met

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.