Not yet recruiting NCT06900764
A Study of CAR-T Cells in Subjects With Systemic Lupus Erythematosus
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: Systemic Lupus Erythematosus (SLE). 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 Systemic Lupus Erythematosus (SLE)
Overview
The purpose of this study is to assess the safety and efficacy of CAR-T cell therapy in Subjects with SLE.
Interventions
- Drug CAR-T cell
CAR-T cell
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 65 years old;
- Diagnosed with SLE according to 2019 EULAR/ACR SLE classifications;
- Positivity for ANA (titer≥1:80), and/or anti-dsDNA, and/or anti-Smith antibody at screening;
- SLEDAI-2K≥8 points (with a clinical SLEDAI-2K≥6 points) ;
- Patients who have used stable standard treatment regimen for at least 6 months in their medical history before screening, and their condition is still active for at least 2 months before screening.
- 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
- Wuhan Union Hospital — Wuhan
Identifiers
NCT: NCT06900764 · AID04-01