A Study of CAR-T Cells in Subjects With Autoimmune Diseases
A Study to Evaluate the Safety and Efficacy of CAR-T Cells in Subjects With Autoimmune Diseases
1 other identifier
interventional
12
1 country
1
Brief Summary
The purpose of this study is to assess the safety and efficacy of CAR-T cell therapy in Subjects with autoimmune diseases.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Sep 2025
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2025
CompletedFirst Posted
Study publicly available on registry
June 27, 2025
CompletedStudy Start
First participant enrolled
September 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2028
July 20, 2025
July 1, 2025
2.2 years
June 18, 2025
July 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Dose Limiting Toxicity
0~28 day after treatment
Frequency of adverse events, serious adverse events
within 24 months after treatment
Study Arms (1)
CAR-T treatment
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Male or female, between 18 and 65 years old;
- 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；
- Good organ functions;
- Subjects must understand and personally, voluntarily sign and date an informed consent.
You may not qualify if:
- Had or has active malignancy;
- Patients who have previously received CD19-targeted drugs, or CAR-T therapy, or any other gene therapy products;
- Combined with other autoimmune disease that needs systemic treatment or therapy;
- Pregnant or lactating women;
- Has other factors that deemed not suitable by investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jian Zhu
Chinese PLA General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
June 18, 2025
First Posted
June 27, 2025
Study Start
September 30, 2025
Primary Completion (Estimated)
November 30, 2027
Study Completion (Estimated)
April 30, 2028
Last Updated
July 20, 2025
Record last verified: 2025-07