CAR-T in Subjects With Relapsed/Refractory Autoimmune Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorShenZhen Cell Valley
About this trial
In this study, CD19 CAR-T cells were administered to patients with relapsed/refractory autoimmune diseases. This study intends to use retroviral vector-based tandem CAR-T cells targeting CD19 to treat autoimmune disease. The CAR-T cells were provided by Shenzhen Cell Valley. A study published in the New England Journal of Medicine provides strong evidence for the therapeutic potential of CD19 CAR-T therapy in autoimmune diseases. The study enrolled 15 participants, including eight with severe SLE, three with idiopathic inflammatory myositis, and four with systemic sclerosis. The median follow-up was 15 months (4 to 29 months). Data from the clinical trial showed that all patients with SLE had a remission of DORIS, all patients with idiopathic inflammatory myositis had an ACR-EULAR major clinical response, all patients with systemic sclerosis had a decrease in the EUSTAR activity index score, and all patients discontinued immunosuppressive therapy completely. The investigators look forward to expanding the use of CAR-T cells in relapsed/refractory autoimmune diseases through this safety and efficacy clinical study and greatly enhancing the quality of life for these patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age 18-65 years (including threshold) and gender;
positive expression of CD19 in peripheral blood B cells as determined by flow cytometry;
Bone marrow function needs to meet the following requirements: a. White blood cell count ≥3×109/L; b. Neutrophil count ≥1×109/L (no colony-stimulating factor treatment within 2 weeks prior to the examination); c. Hemoglobin ≥60g/L;
Liver function: ALT≤3×ULN (except for elevated ALT caused by inflammatory myopathy); AST≤3×ULN (except for AST elevation caused by inflammatory myopathy); TBIL≤1.5×ULN (except for Gilbert's disease).
Disqualifiers
A history of severe drug allergies or sensitivities;
the presence or suspicion of fungal, bacterial, viral or other infections that are uncontrolled or require treatment
persons with central nervous system disorders caused by ADs or not caused by ADs.
those with intolerable cardiac function;
Trial design
Design model
Single group
Treatments tested in this trial
CD19 CAR-T cells were administered to patients with relapsed/refractory autoimmune diseases
DrugThis is a prospective, single-center, open, single-arm, dose-escalation clinical trial to evaluate the safety and efficacy of CAR-T cell therapy in patients with relapsed/refractory autoimmune diseases. Intravenous infusion will be used, and the trial procedure will be divided as follows: 1. Screening period (D-28 to D-6): After subjects voluntarily sign an informed consent form, a screening period will be conducted to determine whether subjects are eligible for the trial based on inclusion and exclusion criteria. 2. Lymphocyte depletion pretreatment (Study D-5 to Study D-3): Subjects will be pre-treated with Lymphocyte depletion starting 5 days prior to CAR-T cell infusion (FC regimen) 3. Rest and Observation (Study D-2 to Study D-1): Follow the study procedures and perform the relevant examinations during the rest and observation period. 4. Cell Infusion and Primary Study Endpoint Observation Period (Study D0 to W12 post-infusion):Subjects will undergo CAR-T cell infusion at 2-da
Treatment groups
3 Participants
are divided into 1 treatment groupGroup A: relapsed/refractory autoimmune diseasesExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
chimeric status
Detecting the chimerism in recipients' peripheral blood and bone marrow.Chimerism is generally measured in percentages(%)
Time frame
1 year after transplantationSponsors and contacts
Click on the lead sponsor to view all of their trials.
ShenZhen Cell Valley
Lead sponsor
First Hospital of China Medical University
Collaborator
Source ClinicalTrials.gov