Alnuctamab for Refractory SLE (LATTE Study)

Not Applicable

Not yet recruiting

• Conditions: Systemic Lupus Erythematosus
• Interventions: Drug: Alnuctamab

• Registration Number: NCT07219563
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Detailed Description

The purpose of this research study is for researchers to learn if the investigational therapy called alnuctamab (known as BMS-986349, CC-93269, EM901) is safe and effective to treat refractory Systemic Lupus Erythematosus (SLE). CC-93269 is investigational, which means its safety and effectiveness have not been established and it is not approved by the U.S. Food and Drug Administration (FDA) for SLE. This will be the first study testing CC-93269 in SLE. Alnuctumab is a type of treatment known as a T cell engager. It is a special protein engineered in the laboratory, which is able to attach to T cells, a type of white blood cell that can kill other cells in the body. T cells normally protect the body from infections, for example by destroying the cells where the virus hides. In this case, alnuctumab will redirect T cells to a new target, called the plasma B cell. This is a type of white blood cell that plays an important role in activating the autoimmune response in patients with lupus. By linking T cells to the autoimmune plasma B cells, alnuctumab will allow the removal of these pathogenic cells. The goal is to evaluate whether this will be sufficient and safe to treat lupus.

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-20
• Study First Submitted QC: 2025-10-20
• Last Update Submitted: 2025-10-20
• Study First Posted: 2025-10-22
• Last Update Posted: 2025-10-22
• Study Start: 2025-12-01
• Primary Completion: 2027-12-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 21

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Participants with Lupus	Alnuctamab	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.

Primary Outcome Measures

Name	Time	Method
Number of treatment emergent AEs	9 days	Type, frequency, and severity of treatment emergent AEs, SAEs, DLTs, and AEs of special interest (e.g., CRS, ICANS)

Secondary Outcome Measures

Name	Time	Method
Maximum concentration of Alnuctamab	0-29 days	The maximum concentration of Alnuctamab (Cmax) following multiple subcutaneous (SC) administrations in participants with moderate to severe SLE refractory to standard therapy
Change in SLE Responder Index (SRI) rate	Baseline, Week 24 and Week 52	SLE Responder Index (SRI) rate at Week 24, Week 52 compared to baseline; SRI is defined as the proportion of participants achieving ≥4 point reduction in SLEDAI-2K \[Systemic Lupus Erythematosus Disease Activity Index\], with no new A organ domain score, ≤ 1 new BILAG \[British Isles Lupus Assessment Group\] B score, and no worsening of the Physician Global Assessment (PGA) score; SLEDAI-2K: Total score ranges from 0-105 with higher score indicating greater disease activity BILAG: B Score implies need for a modest dose of steroids. PGA: Score range from -3 (poorer health outcome) to 3 (better health outcome)

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States