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

January 1, 2025 updated by: He Huang, Zhejiang University

A Study to Evaluate the Safety and Efficacy 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

6

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: He Huang, MD/PhD
  • Phone Number: +（86）0571-87236703
  • Email: hehuangyu@126.com

Study Locations

  • China
      • Hangzhou, China
        • First affiliated Hospital of Zhejiang University
        • Contact:
          • He Huang, MD/PhD
          • Phone Number: +（86）0571-87236703

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CAR-T treatment
Drug: CAR-T cell
CAR-T cell

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose Limiting Toxicity
Time Frame: 0~28 day after treatment
0~28 day after treatment
Frequency of AEs, SAEs
Time Frame: 0 day to 24 months after treatment
0 day to 24 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 10, 2025

Primary Completion (Estimated)

August 5, 2027

Study Completion (Estimated)

November 15, 2027

Study Registration Dates

First Submitted

January 1, 2025

First Submitted That Met QC Criteria

January 1, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 1, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AID03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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