Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06661811

A Study of CAR-T Cells Targeting Autoimmune Diseases

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Gaobo Boren Hospital

Beijing, 100070, China

Location contact

Yajing Zhang, MD/PhD

CONTACT

[email protected]

+8601083605002(716)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female, between 18 and 56 years old;
  • Diagnosed with Autoimmune Diseases;
  • 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.

Treatment and study plan

CAR-T

Drug

CAR-T cells

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.

Yajing Zhang, MD/PhD

CONTACT

[email protected]

+8601083605002(716)

Sponsors and collaborators

Lead sponsor

Beijing Boren Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Oct 28, 2024
Registry last updated
Oct 28, 2024

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.

Published trials that share one or more normalized conditions with this study.