Clinical Trial

CD19-Directed Chimeric Antigen Receptor Autologous T Cells (CART19) for Lupus

Recruiting Phase 1/2
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Summary
This is a single-center, single-arm, open-label phase 1/2 study of CART19 in children and young adults with refractory Systemic lupus erythematosus (SLE), including both patients diagnosed with lupus nephritis (LN) and patients with non-renal Systemic lupus erythematosus (SLE). Phase 1 will evaluate the safety of CART19 in 6-12 patients with Systemic lupus erythematosus (SLE). There is no planned dose escalation, but a dose de-escalation will be made based on the incidence of Dose Limiting Toxicities. Phase 2 will evaluate the efficacy and further evaluate the safety of CART19 in this population.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2025-02-17; most recent amendment 2026-06-11.
Status change: Not Yet Recruiting → Recruiting 2025-03-03
Trial Details
NCT Number NCT06839976
Lead Sponsor Children's Hospital of Philadelphia
Conditions SLE, Systemic Lupus Erythematosus (SLE), CAR T Cell, CART19, Cell Therapy, Lupus, Lupus Nephritis (LN)
Enrollment 24 participants
Start Date 2025-05-06
Primary Completion 2030-02-28 (estimated)
Study Completion 2030-02-28 (estimated)
Updated on ClinicalTrials.gov 2026-06-15