A Study of CAR-T Cells Targeting Autoimmune Diseases

NCT ID: NCT06661811

Last Updated: 2024-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-15

Study Completion Date

2028-06-20

Brief Summary

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

Detailed Description

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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.

Conditions

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Autoimmune Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CAR-T treatment

Group Type EXPERIMENTAL

CAR-T

Intervention Type DRUG

CAR-T cells

Interventions

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CAR-T

CAR-T cells

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Boren Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yajing Zhang, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

Beijing Gaobo Boren Hospital

Locations

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Beijing Gaobo Boren Hospital

Beijing, , China

Site Status

Countries

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China

Central Contacts

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Yajing Zhang, MD/PhD

Role: CONTACT

+8601083605002(716)

Facility Contacts

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Yajing Zhang, MD/PhD

Role: primary

+8601083605002(716)

Other Identifiers

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AID02

Identifier Type: -

Identifier Source: org_study_id

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