Alnuctamab treatment for refractory SLE

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Alnuctamab is a bispecific T-cell engager that binds BCMA on plasma B cells and redirects cytotoxic T cells to remove autoantibody-producing cells. This Phase 1, single-site study at Icahn School of Medicine at Mount Sinai will enroll adults with moderate-to-severe SLE refractory to corticosteroids and multiple immunosuppressive therapies. The primary focus is on safety, tolerability, and identifying an appropriate dose, with secondary measures of disease activity and biomarker changes. Participants will receive alnuctamab and undergo frequent clinical and laboratory monitoring for adverse events and effects on autoantibodies and SLE activity.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Age 18-60 years.
* Documented diagnosis of SLE fulfilling 2019 ACR/EULAR criteria.
* Historical documentation of ANA (1:80 or greater) autoantibody on immunofluorescence as well as presence of at least 1 additional autoantibody of the type: anti-dsDNA, anti-histone, anti-chromatin, anti-Smith, anti-RNP, anti-Ro/SSA, anti-La/SSB, anti-cardiolipin (IgG), or anti-beta2-glycoprotein1 (IgG).
* History of SLE that is refractory to corticosteroids and at least 2 immunosuppressive therapies with different mechanisms of action (methotrexate, thiopurines, mycophenolate mofetil, calcineurin inhibitors, biologic agents, cyclophosphamide), including at least one biologic therapy (e.g. anti-CD20 therapy, anifrolumab, belimumab) or cyclophosphamide. Of note, hydroxychloroquine is not considered an immunosuppressive therapy, and methotrexate/azathioprine counts as a single drug class).
* Total SLEDAI-2K \>6 with clinical SLEDAI-2K \>4, or \>1 BILAG A organ domain score, or \>2 BILAG B, but without active central nervous system (CNS) disease within the past year; a maximum of two participants with only arthritis and/or rash can be included if truly disabling

Key Exclusion Criteria:

* Autoimmune disease other than SLE, except associated Sjogren's Disease if not primary contributor to symptoms; coexistent fibromyalgia will be allowed if not primary contributor to symptoms.
* TTP-like SLE; catastrophic APS; LN WHO class V as primary qualifying criterion (unless overlap with Class III or IV), rapidly progressive LN, or eGFR \<40 mL/min; active CNS pathology attributable to neuropsychiatric SLE.
* Active or suspected infection, including HIV.
* 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.

Where it's running

• Icahn School of Medicine at Mount Sinai
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Chrisanna Dobrowolski, MD — Icahn School of Medicine at Mount Sinai School
• Study coordinator: Chrisanna Dobrowolski, MD
• Email: latte@mssm.edu
• Phone: 212-241-1671

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.