Mosunetuzumab for Lupus

Recruiting at 9 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

15 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

How is the drug Mosunetuzumab different from other drugs for lupus?

Mosunetuzumab is unique because it is a bispecific antibody that targets both CD20 and CD3, which helps redirect T-cells to attack B-cells involved in lupus. This mechanism is different from other lupus treatments that typically target only one type of immune cell or pathway. ^{1 2 3 4 5}

Research Team

Clinical Trials

Principal Investigator

Hoffmann-La Roche

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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, 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of ustekinumab, an IL-12 and IL-23 inhibitor, in patients with active systemic lupus erythematosus: results of a multicentre, double-blind, phase 2, randomised, controlled study. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Treatment of systemic lupus erythematosus with epratuzumab. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Efficacy of Routinely Administered Belimumab on Proteinuria and Neuropsychiatric Lupus. [2020]

4. England pubmed.ncbi.nlm.nih.gov

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

5. England 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. [2017]