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RECRUITING
NCT06839976
PHASE1/PHASE2

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

Sponsor: Children's Hospital of Philadelphia

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

12 Years - 29 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2025-05-06

Completion Date

2030-02-28

Last Updated

2026-02-23

Healthy Volunteers

No

Interventions

BIOLOGICAL

CART19

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

Locations (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States