A Study of CAR-T Cells in Subjects with Autoimmune Diseases

Early Phase 1

Not yet recruiting

• Conditions: Autoimmune Diseases
• Interventions: Drug: CAR-T cell

• Registration Number: NCT06762119
• Lead Sponsor: Zhejiang University

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-01
• Study First Submitted QC: 2025-01-01
• Last Update Submitted: 2025-01-01
• Study First Posted: 2025-01-07
• Last Update Posted: 2025-01-07
• Study Start: 2025-01-10
• Primary Completion: 2027-08-05
• Study Completion: 2027-11-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

1. Male or female, between 18 and 65 years old;
2. 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；
3. Good organ functions;
4. Voluntary participates this trial and can comprehend and sign ICF.

Key

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CAR-T treatment	CAR-T cell	-

Primary Outcome Measures

Name	Time	Method
Dose Limiting Toxicity	0~28 day after treatment
Frequency of AEs, SAEs	0 day to 24 months after treatment

Trial Locations

Locations (1)

First Affiliated Hospital of Zhejiang University; 🇨🇳 Hangzhou, China