A Study of CAR-T Cells in Subjects With Autoimmune Diseases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CAR-T cell.
- Who it may be relevant to
- Registry conditions: Autoimmune Diseases. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Study to Evaluate the Safety and Efficacy of CAR-T Cells in Subjects With Autoimmune Diseases
Overview
The purpose of this study is to assess the safety and efficacy of CAR-T cell therapy in Subjects with autoimmune diseases.
Detailed description
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.
Interventions
- Drug CAR-T cell
CAR-T cell
Primary outcome measures
- Dose Limiting Toxicity [Time frame: 0~28 day after treatment]
- Frequency of adverse events, serious adverse events [Time frame: within 24 months after treatment]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Chinese PLA General Hospital — Beijing
Identifiers
NCT: NCT07040917 · AID01