The Safety and Efficacy of Anti-CD19 CAR-T Cells in Patients With Relapsed/Refractory Autoimmune … (NCT06420154) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
The Safety and Efficacy of Anti-CD19 CAR-T Cells in Patients With Relapsed/Refractory Autoimmune Diseases
China9 participantsStarted 2024-05-27
Plain-language summary
This is an investigator-initiated trial to evaluate the safety and efficacy of anti- CD19-CAR-T cells in the relapse or refractory autoimmune diseases.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Voluntarily participate in clinical research. The person or legal guardian fully understands and informs the research and signs the informed consent form (ICF), and is willing to follow and complete all trial procedures;
✓. Aged 18-65 years old;
✓. ECOG score ≤ 2 points;
✓. Expected survival period is at least 12 weeks;
✓. Have good intravenous access (for apheresis) and have no other contraindications to blood cell separation;
✓. When screening patients, laboratory tests must meet the following requirements and they must not have received cell growth factors within 7 days before screening hematology assessment (long-acting colony-stimulating factor (G-CSF/PEG-CSF) requires an interval of 2 weeks):
✓. Absolute neutrophil count ≥1.0×10\^9/L;
✓. Hemoglobin ≥60 g/L (without red blood cell transfusion within 14 days);
Exclusion criteria
✕. Have active central nervous system diseases, such as epilepsy, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving the central nervous system;
✕. Fungal, bacterial, viral or other infections exist or are suspected and are not controlled or require intravenous antibiotic treatment; simple urinary tract infections and uncomplicated bacterial pharyngitis are allowed;
✕
What they're measuring
1
Incidence of dose-limiting toxicity
Timeframe: Up to 28 days from CAR-T infusion
2
Laboratory abnormalities and type, frequency and severity of adverse events
Timeframe: Up to1 year from CAR-T infusion
3
Proportion of patients for whom a CAR-T cell product could be prepared
Timeframe: Up to 4 days from apheresis
Trial details
NCT IDNCT06420154
SponsorFirst Affiliated Hospital of Wenzhou Medical University
. Suffering from hepatitis B (hepatitis B virus surface antigen and hepatitis B DNA \>1000 copies/ml) or hepatitis C (positive hepatitis C antibody test); syphilis infection (antibody positive); human immunodeficiency virus (HIV) infection;
✕. Past medication:
✕. CD19 targeted therapy;
✕. Inject live vaccines within 4 weeks before enrollment;
✕. Immunosuppressive antibodies (such as anti-CD20, anti-tumor necrosis factor, anti-interleukin 6 or anti-interleukin 6 receptor) used within 4 weeks before enrollment;
✕. Use immunostimulatory or immune enhancer treatment (such as tacrolimus, cyclosporine, interferon-α, interferon-β, IL-2) within the 5 half-lives before apheresis;