A Study of CAR-T Cells Targeting Autoimmune Diseases

October 25, 2024 updated by: Beijing Boren Hospital

A Study of CAR-T Cells Targeting B Cell Related Autoimmune Diseases

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Autoimmune disease refers to the disease in which the immune system reacts to the host's own body and causes damage to tissues and organs.

Autoreactive B cells can self-activate and differentiate into plasma cells releasing large amounts of autoantibodies, while they can also present their own antigens to autoimmune T cells, thus activating T cells and promoting the release of inflammatory factors.

CAR-T cells can theoretically completely deplete abnormal antibody-producing B cells, allowing immune rebuilding and restoring the patient's normal immune function, achieving drug-free survival, which fully reflects the application prospects of CAR-T therapy in autoimmune disease.

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Not Applicable

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

Study Locations

  • China
      • Beijing, China, 100070
        • Beijing Gaobo Boren Hospital
        • Contact:

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

Inclusion Criteria:

  1. Male or female, between 18 and 56 years old;
  2. Diagnosed with Autoimmune Diseases；
  3. Good organ functions;
  4. Voluntary participates this trial and can comprehend and sign ICF.

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
CAR-T cells

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

Beijing Boren Hospital

Investigators

  • Principal Investigator: yajing zhang, MD/PhD, Beijing Gaobo Boren Hospital

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)

November 15, 2024

Primary Completion (Estimated)

April 20, 2028

Study Completion (Estimated)

June 20, 2028

Study Registration Dates

First Submitted

October 25, 2024

First Submitted That Met QC Criteria

October 25, 2024

First Posted (Actual)

October 28, 2024

Study Record Updates

Last Update Posted (Actual)

October 28, 2024

Last Update Submitted That Met QC Criteria

October 25, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AID02

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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