Mosunetuzumab for Lupus

No longer recruiting at 10 trial locations

Overseen By Reference Study ID Number: GA43191 https://forpatients.roche.com/

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Hoffmann-La Roche

Must be taking: Oral corticosteroids, antimalarials, immunosuppressants

Must not be taking: Anti-CD19, anti-CD20, JAK inhibitors, others

Disqualifiers: Pregnancy, severe renal disease, cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called mosunetuzumab (also known as Lunsumio) for individuals with systemic lupus erythematosus (SLE), a condition where the immune system attacks the body’s own tissues. The trial aims to assess the safety, tolerability, and behavior of this treatment in the body. Participants will receive either a single dose or a divided dose of the drug. It suits those who have had SLE for at least 12 weeks, are experiencing active symptoms, and are currently on stable SLE treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but you must be on stable doses of standard SLE therapies like oral corticosteroids, antimalarial agents, or conventional immunosuppressants. Certain medications, like specific biologics and investigational therapies, are not allowed during the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that mosunetuzumab has a good safety record in people with systemic lupus erythematosus (SLE). Early results from past studies suggest that most people handle the treatment well, experiencing no serious side effects. However, as with all treatments, some side effects were reported, though they were usually mild.

This study is in its early stages, focusing primarily on the safety and tolerability of the treatment. If mosunetuzumab is already approved for other conditions, it may have a known safety record, which can be reassuring for its use in SLE. Consulting a healthcare professional is essential to determine if joining a trial is suitable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lupus?

Mosunetuzumab is unique because it offers a new approach to treating lupus by using a bispecific antibody that targets both CD20 and CD3 proteins, which are involved in the immune response. Unlike traditional lupus treatments, which often include corticosteroids and immunosuppressants to broadly dampen the immune system, mosunetuzumab specifically directs immune cells to target and destroy B cells, potentially reducing side effects and improving precision. Researchers are excited about its potential to provide a more targeted, effective treatment with potentially fewer side effects compared to standard therapies.

What evidence suggests that mosunetuzumab could be an effective treatment for lupus?

Research has shown that mosunetuzumab appears safe for people with systemic lupus erythematosus (SLE). Current studies, including this trial, primarily assess the treatment's safety and tolerability. Participants in this trial will receive either a single dose or a fractionated (divided) dose of mosunetuzumab. Designed to adjust the immune system, mosunetuzumab may help reduce the inflammation that damages tissues in SLE. Although detailed information on its effectiveness for SLE is limited, the treatment builds on successful therapies for other autoimmune diseases. Early signs suggest mosunetuzumab could be effective for SLE, but further research is needed to confirm this. ^{1 2 4 5 6}

Who Is on the Research Team?

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I was diagnosed with lupus more than 12 weeks ago.

My tests show SLE autoantibodies like ANA, anti-dsDNA, or anti-Sm.

Exclusion Criteria

I have had symptoms of mixed connective tissue disease or systemic sclerosis in the last year.

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive mosunetuzumab, either as a single dose or fractionated dose on Days 1 and 8

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mosunetuzumab
• Tocilizumab

Trial Overview 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.

How Is the Trial Designed?

Group I: Non-fractionated/Dose-finding Experimental Treatment 2 Interventions

Participants will receive a single dose of mosunetuzumab.

Group II: Fractionated/Dose-escalation Experimental Treatment 2 Interventions

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

Mosunetuzumab is already approved in European Union, United States for the following indications:

Approved in European Union as Lunsumio for:

• Relapsed or refractory follicular lymphoma after two or more lines of systemic therapy

Approved in United States as Lunsumio for:

• Relapsed or refractory follicular lymphoma after two or more lines of systemic therapy

Who Is Running the Clinical Trial?

Hoffmann-La Roche

Lead Sponsor

Trials

2,482

Recruited

1,107,000+

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Avastin, Herceptin, Rituxan, Accu-Chek

Dr. Levi Garraway

Hoffmann-La Roche

Chief Medical Officer since 2019

MD from the University of Basel

Dr. Thomas Schinecker

Hoffmann-La Roche

Chief Executive Officer since 2023

PhD in Molecular Biology from New York University

Published Research Related to This Trial

Epratuzumab, a humanized monoclonal antibody targeting B cells, may safely and effectively reduce B cell activity in patients with systemic lupus erythematosus, based on preliminary uncontrolled studies.

A randomized controlled trial is currently underway to further evaluate the safety and efficacy of epratuzumab for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting B cells in systemic lupus erythematosus: not just déjà vu all over again. Eisenberg, R.[2018]

In a retrospective study of 16 patients with systemic lupus erythematosus (SLE) receiving belimumab (BEL), three patients with severe lupus nephritis showed significant reductions in proteinuria, indicating BEL's potential efficacy in this non-approved indication.

One patient with neuropsychiatric systemic lupus erythematosus (NPSLE) experienced clinical improvement after BEL treatment, suggesting that BEL may also benefit patients with this severe manifestation, although careful patient selection is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Efficacy of Routinely Administered Belimumab on Proteinuria and Neuropsychiatric Lupus. Plüß, M., Tampe, B., Niebusch, N., et al.[2020]

Epratuzumab treatment showed promising efficacy in patients with moderately-to-severely active systemic lupus erythematosus (SLE), with a response rate of 44.1% at week 12 for the 360 mg/m² dose compared to 30.0% for placebo, although the trials were prematurely discontinued due to drug supply issues.

The safety profile of epratuzumab was comparable to placebo, with no new safety concerns identified during the study, supporting its potential as a treatment option for SLE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of epratuzumab in patients with moderate/severe flaring systemic lupus erythematosus: results from two randomized, double-blind, placebo-controlled, multicentre studies (ALLEVIATE) and follow-up. Wallace, DJ., Gordon, C., Strand, V., et al.[2017]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003496725025622

POS1160 A PHASE IB, MULTICENTRE, OPEN-LABEL ... Preliminary data from this Phase Ib study indicated that mosunetuzumab exhibits an acceptable safety profile in patients with SLE.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05155345

NCT05155345 | A Study to Evaluate the Safety, Tolerability ... This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of mosunetuzumab in participants with systemic lupus erythematosus ( ...

3. genentech-clinicaltrials.com genentech-clinicaltrials.com/en/trials/autoimmune-disorder/sle/a-study-to-evaluate-the-safety--tolerability--pharmacok-87119.html

Clinical Trial - Comparing different doses of Mosunetuzum... Study Summary​​ This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of mosunetuzumab in participants with systemic lupus ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10179673/

Targeted Therapy for SLE—What Works, What Doesn't, What's ... In this article, we will review the approved biologics for SLE patients, those that were effective in phase II trials and are currently in phase III trials, ...

5. withpower.com withpower.com/trial/phase-1-lupus-erythematosus-systemic-11-2021-25cd9

Mosunetuzumab for Lupus · Info for Participants Epratuzumab treatment showed promising efficacy in patients with moderately-to-severely active systemic lupus erythematosus (SLE), with a response rate of 44.1% ...

6. genentech-clinicaltrials.com genentech-clinicaltrials.com/content/patient-platform/na/us/en/trials/autoimmune-disorder/sle/a-study-to-evaluate-the-safety--tolerability--pharmacok-87119.pdf

A clinical trial to compare different doses of mosunetuzumab ... of mosunetuzumab in participants with systemic lupus erythematosus (SLE). ... This clinical trial aims to test the safety of mosunetuzumab at different ...