Actively Recruiting

Phase 1
Age: 18Years - 60Years
All Genders
NCT07219563

Alnuctamab for Refractory SLE (LATTE Study)

Led by Icahn School of Medicine at Mount Sinai · Updated on 2026-04-21

21

Participants Needed

1

Research Sites

89 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Alnuctamab for Refractory SLE (LATTE Study)

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 60 years
  • Diagnosed with Systemic Lupus Erythematosus (SLE) meeting 2019 ACR/EULAR criteria
  • Documented history of ANA autoantibody (1:80 or greater) and at least one additional specific autoantibody
  • SLE that has not responded to corticosteroids and at least two different immunosuppressive treatments, including at least one biologic therapy or cyclophosphamide
  • Active SLE with specific disease activity scores or disabling arthritis and/or rash (maximum of two participants with only arthritis and/or rash) without active central nervous system disease in the past year
Not Eligible

You will not qualify if you...

  • Presence of autoimmune diseases other than SLE, except Sjogren's Disease if not the main cause of symptoms; fibromyalgia allowed if not primary cause
  • Thrombotic thrombocytopenic purpura-like SLE, catastrophic antiphospholipid syndrome, certain severe kidney disease forms, rapidly progressing lupus nephritis, or active neuropsychiatric SLE
  • Active or suspected infections, including HIV
  • Low oxygen saturation below 92% on room air
  • Low blood counts: neutrophils below 1500/uL, hemoglobin below 8 g/dL, platelets below 75,000/uL
  • Elevated liver enzymes more than twice the normal limit unless due to active muscle inflammation
  • High total bilirubin over 1.5 times normal unless caused by Gilbert's Disease
  • Very low total B cell count below 12/microliter or low immunoglobulin levels below 500 mg/dL

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

Actively Recruiting

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Research Team

C

Chrisanna Dobrowolski, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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