Alnuctamab for Lupus
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the safety and initial effectiveness of alnuctamab, a new treatment for lupus. It focuses on individuals with moderate to severe lupus who haven't responded to standard treatments. This trial may suit those who have had lupus for some time and continue to experience symptoms despite trying various medications. Participants will receive the study drug in small groups initially to closely monitor any effects. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop your current medications. However, it mentions that participants should have a history of SLE that is refractory to certain treatments, which might imply that some medications could be continued. It's best to discuss your specific medications with the trial coordinators.
Is there any evidence suggesting that alnuctamab is likely to be safe for humans?
Research has shown that alnuctamab, a treatment under study for lupus, appears safe. This therapy targets BCMA, a protein involved in certain immune responses. Current data suggest that alnuctamab has side effects that most people with systemic lupus erythematosus (SLE) can manage without much trouble.
The study is in an early phase, focusing primarily on assessing the treatment's safety in humans. Although detailed results are not yet available, this phase is crucial for identifying any serious side effects. So far, no major concerns have been reported for alnuctamab. Prospective participants might find this information reassuring regarding the treatment's safety.12345Why do researchers think this study treatment might be promising for lupus?
Alnuctamab is unique because it targets lupus in a new way by using a novel mechanism of action, potentially offering more precise treatment options. While most lupus treatments focus on broadly suppressing the immune system, Alnuctamab is designed to specifically target and modulate certain immune pathways, which may reduce inflammation more effectively and with fewer side effects. Researchers are excited about this treatment because it could lead to quicker improvements and better quality of life for patients with lupus compared to current therapies.
What evidence suggests that alnuctamab might be an effective treatment for lupus?
Research suggests that alnuctamab could be promising for treating systemic lupus erythematosus (SLE). Alnuctamab targets specific cells involved in the disease, helping T cells, which protect against infections, connect with harmful plasma B cells that contribute to lupus, potentially eliminating these problematic cells. Early results from studies on other conditions showed a response rate of up to 67% at certain doses. Although specific data for lupus remains limited, the mechanism of alnuctamab suggests potential effectiveness. Participants in this trial will receive alnuctamab, starting with initial sentinel dosing to closely monitor a small number of participants before administering the study drug to all participants.26789
Who Is on the Research Team?
Chrisanna Dobrowolski, MD
Principal Investigator
Icahn School of Medicine at Mount Sinai School
Are You a Good Fit for This Trial?
This trial is for adults aged 18-60 with moderate to severe SLE, not responding well to standard treatments including steroids and at least two different immunosuppressives. Participants must meet specific criteria for disease activity and have certain autoantibodies. Excluded are those with low blood counts, liver issues, other autoimmune diseases (except some cases of Sjogren's), severe kidney or CNS involvement, or active infections.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the study drug alnuctamab with sentinel dosing to monitor safety and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Alnuctamab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount Sinai
Lead Sponsor