What side effects are associated with this type of intervention?

Common treatments for Lupus that target B cells, such as Rituximab, can cause side effects including infusion reactions, serum-sickness-like reactions, and increased risk of infections. Other biologic agents may cause injection site reactions, hypersensitivity reactions, and mild neurocognitive symptoms. Serious adverse effects are uncommon but can include progressive multifocal leukoencephalopathy (PML) and interstitial lung disease. It is important to monitor for these side effects and discuss them with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for lupus, including belimumab (Benlysta), which targets B-lymphocyte stimulator (BLyS) to inhibit B cell survival, and anifrolumab (Saphnelo), which targets the type I interferon receptor. While these treatments do not use the same bispecific antibody mechanism as mosunetuzumab, they similarly aim to modulate the immune system by targeting B cells or related pathways. Rituximab, an anti-CD20 monoclonal antibody, has also been used off-label for lupus, directly targeting B cells, which is somewhat similar to the B cell targeting aspect of mosunetuzumab.

What other types of research exist?

Promising novel alternatives to Mosunetuzumab for Lupus patients include: <ol> <li>Rituximab: A monoclonal antibody targeting CD20 on B cells, showing efficacy in various autoimmune diseases.</li> <li></li> </ol> Belimumab: A monoclonal antibody targeting the B-lymphocyte stimulator (BLyS), approved for systemic lupus erythematosus. 3. Tofacitinib: A Janus kinase (JAK) inhibitor, effective in rheumatoid arthritis and showing potential in other autoimmune conditions. 4. Baricitinib: Another JAK inhibitor with demonstrated efficacy in rheumatoid arthritis, potentially beneficial for Lupus. 5. Ustekinumab: A monoclonal antibody targeting interleukin-12 and interleukin-23, used in psoriasis and showing promise in other autoimmune diseases.

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Monoclonal Antibodies

Mosunetuzumab for Lupus

Phase 1

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For men on mycophenolate mofetil (MMF) with a female partner of childbearing potential: agreement to remain abstinent or use contraception as defined by the protocol

Active SLE disease demonstrated by a SLEDAI-2K total score of ≥4 at screening

Must not have

Infections including HIV, HBV, HCV, TB, EBV, CMV, active infection, major episodes of infection, serious recurrent or chronic infection

History of PML, cancer within the past 5 years, major surgery within 4 weeks prior to screening or planned surgery within 12 weeks following study drug administration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new medication called mosunetuzumab to see if it is safe and effective for people with systemic lupus erythematosus (SLE). The medication aims to help the immune system target harmful cells, which may help reduce the symptoms of SLE.

Who is the study for?

This trial is for adults with systemic lupus erythematosus (SLE) who are currently on stable SLE medications and have certain autoantibodies. They must not have severe kidney disease, uncontrolled medical conditions, or a recent history of significant infections or surgeries. Participants should not be pregnant, breastfeeding, or planning pregnancy soon after the trial. Men on specific treatments must also follow contraception guidelines.

What is being tested?

The study tests Mosunetuzumab's safety and how it affects the body in those with SLE. It will look at how well participants tolerate the drug and measure its levels in their system over time to understand its pharmacodynamics.

What are the potential side effects?

Potential side effects may include allergic reactions to monoclonal antibodies like Mosunetuzumab, infusion-related reactions such as fever or chills, fatigue, changes in blood counts leading to increased infection risk or bleeding tendencies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree to follow the birth control requirements while on MMF.

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My lupus is active, with a score of 4 or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have HIV, hepatitis, TB, or other serious infections.

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I haven't had cancer, major surgery recently, or plan to have surgery soon.

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I am allergic or cannot tolerate the study's drugs or their components.

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My lupus has caused serious kidney problems.

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I have had severe antiphospholipid syndrome in the last year.

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I have severe or unstable lupus affecting my nervous system.

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I am at high risk for serious bleeding or need treatment for certain conditions.

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I haven't taken any experimental drugs within the last 30 days or 5 half-lives before starting the study treatment.

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I have not taken specific immune or cancer treatments listed.

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

Side effects data

From 2021 Phase 1 trial • 23 Patients • NCT04313608

41%

Cytokine release syndrome

35%

Anaemia

35%

Diarrhoea

35%

Hypomagnesaemia

35%

Pyrexia

35%

Neuropathy peripheral

24%

Platelet count decreased

24%

Nausea

24%

Hypophosphataemia

24%

Liver function test abnormal

24%

Neutropenia

24%

Constipation

24%

Fatigue

24%

Thrombocytopenia

18%

Arthralgia

18%

Lethargy

18%

Hypokalaemia

18%

Weight decreased

18%

Neutrophil count decreased

18%

Oral candidiasis

18%

Sepsis

18%

Headache

18%

Peripheral sensory neuropathy

12%

Rectal haemorrhage

12%

Paraesthesia

12%

Flushing

12%

Superficial vein thrombosis

12%

Infusion related reaction

12%

Vomiting

12%

Blood alkaline phosphatase increased

12%

Cough

12%

Abdominal pain

12%

Pain in extremity

12%

Gastrooesophageal reflux disease

12%

Alanine aminotransferase increased

12%

Colitis

12%

Abdominal discomfort

12%

Dizziness

Cytomegalovirus infection reactivation

Decreased appetite

Performance status decreased

Upper respiratory tract infection

Hypocalcaemia

Back pain

Chest pain

Hyperlipidaemia

Dyspnoea exertional

Vasospasm

Gamma-glutamyltransferase increased

Abdominal distension

Tumour lysis syndrome

Rash

Thrombosis

External ear cellulitis

Orthostatic hypotension

Cellulitis

Hypogammaglobulinaemia

Urinary tract infection

Transient ischaemic attack

Hypertension

Blood creatinine increased

Abdominal tenderness

Seasonal allergy

Adenocarcinoma

Throat irritation

Injury

Hypoalbuminaemia

Epistaxis

Hyperglycaemia

Oropharyngeal pain

Intention tremor

Wound infection

Rash maculo-papular

Squamous cell carcinoma

Photosensitivity reaction

Depression

Neutropenic sepsis

Vision blurred

Abdominal pain lower

Anal haemorrhage

Aspartate aminotransferase increased

Groin pain

Pain in jaw

100%

80%

60%

40%

20%

Study treatment Arm

Arm A: Glofit-GemOx

Arm B: Mosun-GemOx

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: Non-fractionated/Dose-findingExperimental Treatment2 Interventions

Participants will receive a single dose of mosunetuzumab.

Group II: Fractionated/Dose-escalationExperimental Treatment2 Interventions

Participants will receive a fractionated (divided) dose of mosunetuzumab on Days 1 and 8.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tocilizumab

2012

Completed Phase 4

~1840

Mosunetuzumab

2019

Completed Phase 2

~140

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

Common treatments for Lupus often target the immune system to reduce its attack on the body's own tissues. Mosunetuzumab, a bispecific antibody, targets CD20 on B cells and CD3 on T cells, facilitating T cell-mediated B cell killing. This is crucial because B cells produce autoantibodies that contribute to Lupus. By reducing B cell activity, the treatment aims to decrease harmful autoantibodies. Other treatments, like rituximab, also target CD20 on B cells, while drugs like methotrexate modulate the immune system more broadly. These mechanisms help tailor treatments to reduce the immune dysfunction in Lupus.

Are we aiming to miss in translational autoimmunity treatments?Distinct effects of methotrexate and etanercept on the B cell compartment in patients with juvenile idiopathic arthritis.