A Study to Evaluate the Safety and Efficacy of CAR-T Cells in Subjects with Autoimmune Diseases

Zhejiang University1 site in 1 country6 target enrollmentJanuary 10, 2025

ConditionsAutoimmune Diseases

InterventionsCAR-T cell

DrugsCAR-T cell

Overview

Phase: Early Phase 1
Intervention: CAR-T cell
Conditions: Autoimmune Diseases
Sponsor: Zhejiang University
Enrollment: 6
Locations: 1
Primary Endpoint: Dose Limiting Toxicity
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to assess the safety and efficacy of CAR-T cell therapy in Subjects with autoimmune diseases.

Detailed Description

This study is a single center, one-arm, open label study aimed at evaluate the safety and efficacy of CAR-T Cells to treating Subjects with Autoimmune Diseases.

Registry

clinicaltrials.gov

Start Date

January 10, 2025

End Date

November 15, 2027

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Zhejiang University

Responsible Party

Principal Investigator

He Huang

Professor

First Affiliated Hospital of Zhejiang University

Eligibility Criteria

Inclusion Criteria

•Male or female, between 18 and 65 years old;
•Diagnosed with Autoimmune Diseases, such as Systemic Lupus Erythematosus, Systemic Sclerosis, Idiopahic Inflammatory Myopathies, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Sjögren's Syndrome, Antiphospholipid Syndrome, Immune Thrombocytopenia；
•Good organ functions;
•Voluntary participates this trial and can comprehend and sign ICF.

Exclusion Criteria

•Had or has active malignancy;
•Had been subjected to treatment by CD19 targeted therapy or CAR-T therapy or any gene therapy;
•Combined with other autoimmune disease that needs treatment;
•Pregnant or lactating women;
•Has other factors that deemed not suitable by investigator.