A Study of CAR-T Cells in Subjects With Autoimmune Diseases

NCT ID: NCT07040917

Last Updated: 2025-07-20

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

EARLY_PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2028-04-30

Brief Summary

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

Detailed Description

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This is a single center, one-arm, open label study aiming to evaluate the safety and efficacy of CAR-T cells therapy in subjects with autoimmune diseases.

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 cell

Intervention Type DRUG

CAR-T cell

Interventions

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CAR-T cell

CAR-T cell

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male or female, between 18 and 65 years old;
2. Diagnosed with Autoimmune Diseases, such as Systemic Lupus Erythematosus, Systemic Sclerosis, Idiopahic Inflammatory Myopathies, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Sjögren's Syndrome, Antiphospholipid Syndrome, Immune Thrombocytopenia, Pemphigus;
3. Good organ functions;
4. Subjects must understand and personally, voluntarily sign and date an informed consent.

Exclusion Criteria

1. Had or has active malignancy;
2. Patients who have previously received CD19-targeted drugs, or CAR-T therapy, or any other gene therapy products;
3. Combined with other autoimmune disease that needs systemic treatment or therapy;
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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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jian Zhu

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jian Zhu

Role: PRINCIPAL_INVESTIGATOR

Chinese PLA General Hospital

Locations

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Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Fei Sun

Role: CONTACT

86-01-55499314

Facility Contacts

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Feng Huang

Role: primary

86-01-55499114

Other Identifiers

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AID01

Identifier Type: -

Identifier Source: org_study_id

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