drugset / Trial / NCT06947460

CD19-BCMA CART Cell Therapy for Refractory SLE-LN, SSc, and pSS-PAH

NCT06947460 ↗

Phase 1/2 Recruiting 45 enrolled Beijing GoBroad Hospital
NaSingle-groupOpen-labelTreatment

Summary

This is a single-center, open-label, non-randomized, single-arm clinical trial. Patients with refractory lupus neritis (SLE-LN), systemic sclerosis (SSc), and primary Sjogren syndrome combined with pulmonary artery hypertension (pSS-PAH) receive CD19-BCMA CAR T cell therapy. The primary objective is to prospectively assess the safety of CD19-BCMA CAR T cell therapy in patients with SLE-LN, SSc, and pSS-PAH. The primary endpoint is the type and incidence of dose-limiting toxicity (DLT) within 28 days after CD19-BCMA CAR T cell infusion.

Timeline

Start
2025-04-18
Primary completion
2026-07-01
Completion
2026-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject CD19-BCMA CAR-T cells Cell therapy — —
Background Cyclophosphamide Other / unclassified — —
Background Fludarabine Small molecule — —