Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT06913608

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

A Phase lb Open-Label Study Evaluating the Safety and Efficacy of the Combination of CLBR00l, an Engineered Autologous T Cell Product, and SWI019, a CD19-directed Antibody-based Biologic With or Without Lymphodepletion in Subjects With Autoimmune Disorders Including Systemic Lupus Erythematosus, Systemic Sclerosis, or Idiopathic Inflammatory Myositis

Status
Withdrawn
Phase
Phase 1
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Calibr, a division of Scripps Research · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

CLBR001 + SWI019 is novel switchable CAR-T cell combination therapy comprised of an autologous CAR (chimeric antigen receptor)-T product (CLBR001, the switchable CAR-T cell \[sCAR-T\]) and SWI019 (the "switch" biologic molecule). SWI019 acts as an adapter molecule that controls the activity of the CLBR001 CAR-T cell product.

Conditions

Interventions

TypeNameDescription
COMBINATION_PRODUCTCLBR001 + SWI019Investigational switchable CAR-T cell therapy for autoimmune disorders

Timeline

Start date
2026-03-01
Primary completion
2026-03-03
Completion
2026-03-03
First posted
2025-04-06
Last updated
2026-03-05

Regulatory

Source: ClinicalTrials.gov record NCT06913608. Inclusion in this directory is not an endorsement.