SLE (Systemic Lupus) Clinical Trial
Official title:
Safety/Phase I Study of PiggyBac Transposon Mediated Chimeric Antigen Receptor T Cells Targeting CD-19 in Thai Patients With Refractory Systemic Lupus Erythematosus
A Phase 1 clinical trial to evaluate the safety and efficacy of PiggyBac transposon-mediated Chimeric Antigen Receptor(CAR) T-cells targeting CD19 in refractory Systemic Lupus Erythematosus (SLE) patients who have not responded to standard immunosuppressive treatments.
This is a single-institution phase I study in adults with refractory SLE. Autologous Peripheral Blood Mononuclear Cells will be transduced with a chimeric antigen receptor targeting the B-cell surface antigen CD19 using the PiggyBac Transposon system. Subjects will receive a conditioning lymphodepletion chemotherapy regimen of fludarabine and cyclophosphamide, followed by the infusion of 1x10^6 cells/kg CD-19 CAR T-cells. Subjects will be evaluated post-treatment for toxicity, SLE disease activity, and the persistence of CAR-expressing T cells in vivo. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT06063668 -
Autotaxin as Abiomarker in Systemic Lupus Erythematosus Patients
|
||
| Completed |
NCT05624437 -
BElimumab corticoSteroids Sparing Treatment in Systemic Lupus Erythematosus
|
||
| Recruiting |
NCT06445127 -
Evaluation of Patients With Lupus Nephritis Using Kidney MRI (Magnetic Resonance Imaging)
|
N/A | |
| Recruiting |
NCT04866615 -
Posterior Segment Evaluation of Patients With SLE Using OCT and OCTA
|
||
| Not yet recruiting |
NCT04645225 -
Clinical Characteristic and MEFV Gene Mutations in Patient With Juvenile Onest Systemic Lupus Erythematosus
|
||
| Recruiting |
NCT04604990 -
National Systemic Lupus Erythematosus Prospective Cohort, Saudi Arabia
|
||
| Recruiting |
NCT06056921 -
Safety and Efficacy of CD19 Targeted CAR-T Therapy for Refractory Autoimmune Disease
|
Phase 1 | |
| Recruiting |
NCT06294236 -
Study Evaluating SC291 in Subjects With Severe r/r B-cell Mediated Autoimmune Diseases (GLEAM)
|
Phase 1 | |
| Recruiting |
NCT05866861 -
A Study in Participants With Mild-to-moderate Systemic Lupus Erythematosus
|
Phase 1 |