A Study of CAR-T Cells Targeting Autoimmune Diseases

Beijing Boren Hospital

Status: Not yet enrolling

Conditions: Autoimmune Diseases

Treatments: Drug: CAR-T

Study type: Interventional

Funder types: Other

Identifiers

NCT06661811

AID02

Details and patient eligibility

About

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

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

CAR-T treatment

Experimental group

Treatment:

Drug: CAR-T