A Study of CAR-T Cells Targeting Autoimmune Diseases

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06661811
• Lead Sponsor: Beijing Boren Hospital

Brief Summary

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

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 Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-25
• Study First Submitted QC: 2024-10-25
• Last Update Submitted: 2024-10-25
• Study First Posted: 2024-10-28
• Last Update Posted: 2024-10-28
• Study Start: 2024-11-15
• Primary Completion: 2028-04-20
• Study Completion: 2028-06-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 12

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CAR-T treatment	CAR-T	-

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)

Beijing Gaobo Boren Hospital; 🇨🇳 Beijing, China