A Study of CAR-T Cells Targeting 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.
- 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 of CAR-T Cells Targeting B Cell Related Autoimmune Diseases
Overview
The purpose of this study is to assess the safety and efficacy of CAR-T cell therapy in patients with autoimmune disease.
Detailed 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.
Interventions
- Drug CAR-T
CAR-T cells
Primary outcome measures
- Dose Limiting Toxicity [Time frame: 0~28 day after treatment]
- Frequency of AEs, SAEs [Time frame: 0 day to 24 months after treatment]
Eligibility criteria
Inclusion criteria
- Male or female, between 18 and 56 years old;
- Diagnosed with Autoimmune Diseases；
- Good organ functions;
- Voluntary participates this trial and can comprehend and sign ICF.
Exclusion criteria
- Had or has active malignancy;
- Had been subjected to treatment by CD19 targeted therapy or CAR-T therapy or any gene therapy;
- Combined with other autoimmune disease that needs treatment;
- 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
- Beijing Gaobo Boren Hospital — Beijing
Identifiers
NCT: NCT06661811 · AID02