Alnuctamab for Refractory SLE (LATTE Study)

This study is testing a new investigational drug called alnuctamab (also known as BMS-986349, CC-93269, or EM901) for people with moderate to severe Systemic Lupus Erythematosus (SLE) that hasn't responded to standard treatments. Alnuctamab is a T cell engager, meaning it helps your body's T cells (a type of white blood cell) target and remove other white blood cells called plasma B cells, which are involved in lupus. Researchers want to see if alnuctamab is safe and effective. You might be able to join if you are between 18 and 60 years old, have a confirmed diagnosis of SLE, and have specific autoantibodies (proteins made by your immune system that attack your own tissues) like ANA (1:80 or greater) and at least one other listed type. The main goal is to find out how many side effects occur within the first 9 days of treatment. The study plans to enroll 21 participants, but its current status is unclear.

Study design: This is an interventional study, meaning participants will receive a specific treatment. It is designed to find the best dose of alnuctamab and plans to enroll 21 participants.
What's involved: You will receive alnuctamab as an injection under the skin. For the first 9 days after the injection, you will need to stay in the hospital.
Compensation: Not stated in the trial record.
Follow-up: The primary endpoint measures side effects at 9 days after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Alnuctamab for Refractory SLE (LATTE Study)

Recruiting

PHASE1Ages 18–60InterventionalTreatment

Icahn School of Medicine at Mount Sinai

~21 participants

Updated 2026-04-21 on ClinicalTrials.gov

What's tested:Alnuctamab

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Number of treatment emergent AEs

Measured over 9 days

Conditions

Systemic Lupus Erythematosus

Where it's being run

1 sites across 1 states

New York1

Study leadership

Chrisanna Dobrowolski, MD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai School

Who to contact

Chrisanna Dobrowolski, MD

[email protected]

212-241-1671

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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.

What this trial measures

Number of treatment emergent AEs9 days
Type, frequency, and severity of treatment emergent AEs, SAEs, DLTs, and AEs of special interest (e.g., CRS, ICANS)

Trialytics