drugset / Trial / NCT06913608

A Study to Assess CLBR001+SWI019 in Subjects With Autoimmune Diseases

NCT06913608 ↗

RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to evaluate CLBR001 and SWI019 as a treatment for patients with autoimmune disorders, including systemic lupus erythematosus, systemic sclerosis, and idiopathic inflammatory myositis. Patients will be randomized 1:1 lymphodepletion vs no lymphodepletion arm. Patients will be administered a single infusion of CLBR001 cells followed by cycles of SWI019 with regular assessments of safety and disease response to treatment. The goals are to establish the safety and efficacy of the combination therapy and determine if lymphodepletion is required for efficacy.

Timeline

Start
2026-03
Primary completion
2026-03-03
Completion
2026-03-03

Outcome

Outcome not reported

Stopped (Business): “Business Decision”

Drugs

EvaluationDrugModalityDoseRoute
Subject CLBR001 Cell therapy — —
Subject SWI019 Protein / enzyme biologic — —