NCT06839976

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

CD19-Directed Chimeric Antigen Receptor Autologous T Cells (CART19) for Adolescents and Young Adults With Systemic Lupus Erythematosus (SLE)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 12 Years – 29 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Lupus disease activity is associated with increased numbers of activated naïve B cells and polyclonal expansion of antibody secreting cells, indicating a central role for B cells in the pathogenesis of SLE. While traditional anti-CD19 antibody therapies have been utilized with varying success in the treatment of Systemic lupus erythematosus (SLE), CD19 directed cellular therapies have emerged as an attractive therapeutic option that may lead to immunosuppression-free remission in this population given the ability of CD19 directed CAR T cells to more deeply deplete the B cell compartment. Previous clinical experience utilizing CD19 directed CAR T cells in patients diagnosed with Systemic lupus erythematosus (SLE) have exceeded any other Systemic lupus erythematosus (SLE) therapeutic available; although, those clinical trials have treated a limited number of subjects. During this trial the test article will be CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv:41-BB:TCRζ, administered by IV injection.

Conditions

• SLE
• Systemic Lupus Erythematosus (SLE)
• CAR T Cell
• CART19
• Cell Therapy
• Lupus
• Lupus Nephritis (LN)

Interventions

Type	Name	Description
BIOLOGICAL	CART19	CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv:41-BB:TCRζ, administered by IV injection.

Timeline

• Start date: 2025-05-06
• Primary completion: 2030-02-28
• Completion: 2030-02-28
• First posted: 2025-02-21
• Last updated: 2026-02-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study