drugset / Trial / NCT06947473

Umbilical Cord Blood CD19-BCMA CART Cell Therapy for SLE-LN, SSc, andpSS PAH.

NCT06947473 ↗

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 umbilical cord blood CD19-BCMA CAR T cell therapy. The primary objective is to prospectively assess the safety of umbilical cord blood CD19BCMA CAR T cell therapy in patients with refractory lupus nephritis (SLE-LN), systemic sclerosis (SSc), and primaryjogren syndrome combined with pulmonary artery hypertension. The primary endpoint is the type and incidence of dose-limiting toxicity (DLT) within 28 days after theusion of umbilical cord blood CD19-BCMA CAR T cells. It is anticipated that 45-54 participants will be recruited.

Timeline

Start
2026-03-18
Primary completion
2026-07-01
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject umbilical cord blood CD19-BCMA CAR-T cells Cell therapy — —