Recruiting

Phase 1

AlnuctamabAlnuctamab for Refractory SLE (LATTE Study)

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT07219563

Conditions

Systemic Lupus Erythematosus

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Alnuctamab

Study Details

Brief summary:

This study will assess the safety and preliminary efficacy of the bi-specific TCE, alnuctamab (known as BMS-986349, CC-93269, EM901), targeting BCMA in patients with moderate to severe SLE, refractory to standard-of-care treatments.

Conditions

Systemic Lupus Erythematosus

Study ID

NCT07219563

Start date

Mar 17, 2026

Status verified date

Feb, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

21 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Participants with Lupus

This study drug will be done by sentinel dosing (study drug given to a small number of participants to watch closely) before all the participants receive the study drug.

Interventions

Alnuctamab

The study drug will be given as an injection under the skin. For the first 9 days after the CC-93269 injection, subjects will be staying in the hospital. The goal of this study is to determine the optimal dose of CC-93269 to be safely administered to participants.

Primary outcome measure

Number of treatment emergent AEs [ Time Frame: 9 days ]

Central Contacts and Locations

Central contacts

Chrisanna Dobrowolski, MD

212-241-1671 latte@mssm.edu

Locations

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Chrisanna Dobrowolski, MD

212-241-1671 latte@mssm.edu

Principal Investigator:

Chrisanna Dobrowolski

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Apr 21, 2026

Last verified

Feb, 2026

Keywords

Refractory, Systemic Lupus Erythematosus (SLE)
Severe Refractory Systemic Lupus Erythematosus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-04-21.