Trial intelligence / Profile preview

Anti-BCMA-CD19 CAR-T for Relapsed/Refractory IgG4-Related Disease

NCT07148791Phase 2

Key facts

Status: Recruiting
Start: Sep 2025
Primary completion: Sep 2027
Countries: 1
Sponsor: Chinese PLA General Hospital
Modality: Gene Editing, Gene Silencing, CAR-T Cells

Drugs: anti-BCMA-CD19 CAR-T cells
Conditions: IgG4-related disease (IgG4-RD)

Overview

Phase 2, open-label trial of anti-BCMA-CD19 CAR-T cells in IgG4-related disease (IgG4-RD), sponsored by Chinese PLA General Hospital. Primary endpoints: Incidence of Dose-Limiting Toxicity at 28 days and IgG4-Related Disease Responder Index at 26 weeks. Started Sep 2025; status: recruiting.

Design

Study design: Non-randomizedOpen-label

Who it enrols

Adults with relapsed or refractory IgG4-related disease involving two or more organ systems, who have failed or relapsed after glucocorticoid and/or rituximab therapy.

Endpoints

Primary

Incidence of Dose-Limiting Toxicity28 days
IgG4-Related Disease Responder Index26 weeks

Secondary

Maximum Concentration of CAR-T Cells26 weeks
Time to Maximum Concentration26 weeks
Area Under the Curve90 days
Persistence of CAR-T Cells26 weeks
CD19+ B-cell Count26 weeks
Lesion Size on Imaging26 weeks
Serum IgG4 Level26 weeks
Serum IgE Level26 weeks

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