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Open-label, 4-Part Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Alnuctamab (BMS-986349/CC-93269) in Participants With Moderate to Severe Refractory Systemic Lupus Erythematosus
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.
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.
Age
18 - 60 years
Sex
ALL
Healthy Volunteers
No
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Start Date
March 1, 2026
Primary Completion Date
December 1, 2027
Completion Date
December 1, 2027
Last Updated
February 25, 2026
21
ESTIMATED participants
Alnuctamab
DRUG
Lead Sponsor
Icahn School of Medicine at Mount Sinai
NCT06647069
NCT07371468
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06333483