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NCT Number: NCT06762119

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

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

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Key information

Conditions

Autoimmune Diseases Immune System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

First Affiliated Hospital of Zhejiang University

Hangzhou, China

Location contact

He Huang, MD/PhD

CONTACT

+（86）0571-87236703

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key 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.

Key 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.

Treatment and study plan

CAR-T cell

Drug

CAR-T cell

Primary outcomes

  1. Dose Limiting Toxicity

    Time frame: 0~28 day after treatment

  2. Frequency of AEs, SAEs

    Time frame: 0 day to 24 months after treatment

Study contacts

Contact information is provided by the study sponsor or research team.

He Huang, MD/PhD

CONTACT

[email protected]

+（86）0571-87236703

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 7, 2025
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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