Alnuctamab for Refractory SLE (LATTE Study)

NCT07219563 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: STUDY-24-01686
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of treatment emergent AEs

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

  9 days

Secondary Outcomes (2)

• Maximum concentration of Alnuctamab

  0-29 days

• Change in SLE Responder Index (SRI) rate

  Baseline, Week 24 and Week 52

Study Arms (1)

Participants with Lupus

EXPERIMENTAL

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.

Drug: Alnuctamab

Interventions

Alnuctamab DRUG

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.

Also known as: EM901

Participants with Lupus

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Chrisanna Dobrowolski, MD

  Icahn School of Medicine at Mount Sinai School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chrisanna Dobrowolski, MD

CONTACT

212-241-1671; latte@mssm.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Assistant Professor

Study Record Dates

• First Submitted: October 20, 2025
• First Posted: October 22, 2025
• Study Start: March 17, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Researchers who provide a methodologically sound proposal. For individual participant data meta-analysis. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at (Link tbd).

Locations

US (1)