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

NCT06913608 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2026-03-05

No results posted yet for this study

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.

Conditions

  • Systemic Lupus Erythematosus (SLE)
  • Systemic Sclerosis (SSc)
  • Idiopathic Inflammatory Myopathy (IIM)

Interventions

COMBINATION_PRODUCT

CLBR001 + SWI019

Investigational switchable CAR-T cell therapy for autoimmune disorders

Sponsors & Collaborators

  • Calibr, a division of Scripps Research

    lead OTHER

Principal Investigators

  • Calibr CMO · Calibr-Skaggs, Institute of Innovative Medicines

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2026-03-03
Completion
2026-03-03
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06913608 on ClinicalTrials.gov