Alnuctamab for Lupus

CD
Overseen ByChrisanna Dobrowolski, MD
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Icahn School of Medicine at Mount Sinai
Must be taking: Biologics, Cyclophosphamide
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

CD

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

My lupus is active but not affecting my brain, and it's severe in at least one aspect.
I am between 18 and 60 years old.
I have been diagnosed with lupus according to the 2019 criteria.
See 2 more

Exclusion Criteria

O2 sat <92% on room air; ANC <1500u/L, Hgb <8g/dL, Plt <75,000/uL; ALT or AST > 2X ULN (unless attributed to active myositis), Total Bilirubin >1.5 X ULN (unless Gilbert's Disease), total B cell count <12/microliter, hypogammaglobinemia <500mg/dL
I have an autoimmune disease, but it's not the main cause of my symptoms.
My condition is a severe form of lupus affecting my kidneys, brain, or has led to a rapid loss in kidney function.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the study drug alnuctamab with sentinel dosing to monitor safety and efficacy

29 days
Multiple visits for subcutaneous administrations

Follow-up

Participants are monitored for safety and effectiveness after treatment

52 weeks
Regular visits at Week 24 and Week 52

What Are the Treatments Tested in This Trial?

Interventions

  • Alnuctamab
Trial Overview The LATTE Study is testing the safety and initial effectiveness of Alnuctamab (BMS-986349/CC-93269/EM901) in patients with stubborn SLE. It targets BCMA, a molecule involved in immune responses. The study aims to find out if this new treatment can help where others haven't.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Participants with LupusExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials
933
Recruited
579,000+

Citations

Alnuctamab for Refractory SLE (LATTE Study)By linking T cells to the autoimmune plasma B cells, alnuctumab will allow the removal of these pathogenic cells. The goal is to evaluate ...
Alnuctamab - Drug Targets, Indications, PatentsThe six presentations reported the latest safety and efficacy data for the BsAb: talquetamab, elranatamab, teclistamab, forimtamig, and alnuctamab.
Online Trial Tracker... Efficacy of ATA3219 in Participants With Systemic Lupus Erythematosus ... Alnuctamab, EM901. Icahn School of Medicine at Mount Sinai. Systemic Lupus ...
Bristol Myers Squibb Announces Data at ASH 2023 from ...In the efficacy-evaluable patients treated with SC alnuctamab (n=73), the ORR was 53% across all doses and 67% at the 30 mg target dose. Median ...
Advances in Targeted Therapy for Systemic Lupus ...At week 104, belimumab added to standard therapy improved both primary efficacy renal response (43% vs. 32%) and complete renal response (30% vs ...
Alnuctamab for Lupus · Info for Participants... Alnuctamab will have tolerable side effects & efficacy for patients with Systemic Lupus Erythematosus and Lupus. Learn more about the study.
alnuctamab (CC-93269) / BMSNew P1 trial • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus ... - Q1 2024 Results: Data readout from P1/2 CA058-002 trial ...
8.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/36211347/
Evaluation of anifrolumab safety in systemic lupus ...Conclusion: Anifrolumab is considered a well-tolerated option for the treatment of SLE patients with good safety. Systematic review registration ...
NCT06232707 | A Study to Evaluate Efficacy and Safety of ...The purpose of this study is to evaluate the efficacy and safety of alnuctamab compared to standard of care regimens in participants with relapsed or refractory ...
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