NCT06150651

Safety of PiggyBac Transposon CAR T-cells Targeting CD-19 in Refractory Lupus.

Safety/Phase I Study of PiggyBac Transposon Mediated Chimeric Antigen Receptor T Cells Targeting CD-19 in Thai Patients With Refractory Systemic Lupus Erythematosus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Chulalongkorn University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• SLE (Systemic Lupus)

Interventions

Type	Name	Description
OTHER	PiggyBac Transposon-Mediated CD19 CAR-T Therapy	PiggyBac Transposon-Mediated CD19 CAR-T Therapy (1-2 x 10\^6 cells/kg)

Timeline

• Start date: 2023-12-01
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2023-11-29
• Last updated: 2026-03-23

Locations

1 site across 1 country: Thailand