CD19-BCMA CART Cell Therapy for Refractory SLE-LN, SSc, and pSS-PAH (NCT06947460) | Clinical Trial Compass
RecruitingPhase 1/2
CD19-BCMA CART Cell Therapy for Refractory SLE-LN, SSc, and pSS-PAH
China45 participantsStarted 2025-04-18
Plain-language summary
This is a single-center, open-label, non-randomized, single-arm clinical trial. Patients with refractory lupus neritis (SLE-LN), systemic sclerosis (SSc), and primary Sjogren syndrome combined with pulmonary artery hypertension (pSS-PAH) receive CD19-BCMA CAR T cell therapy. The primary objective is to prospectively assess the safety of CD19-BCMA CAR T cell therapy in patients with SLE-LN, SSc, and pSS-PAH. The primary endpoint is the type and incidence of dose-limiting toxicity (DLT) within 28 days after CD19-BCMA CAR T cell infusion.
Who can participate
Age range10 Years – 65 Years
SexALL
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Inclusion criteria
✓. Male or female, aged 10-65 years;
✓. Meeting the 2019 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Classification Criteria for Systemic Lupus Erythematosus (Appendix 4);
✓. The ANA result is positive which means ANA titer≥ 1:80 (based on the equivalent detection results by Hep-2 immunofluorescence assay or enzyme immune assay), and/or according to the detection results from center laboratory, during the screening visit,the anti dsDNA serum antibody test is positive (based on ELISA assay, ≥30 IU/mL);
✓. B cell CD19+ expression, and stop using immunosuppressant more than one week.
✓. The lymphocyte count in the subject's blood routine \>0.5×109/L, and no contraindications for cell collection;