Umbilical Cord Blood CD19-BCMA CART Cell Therapy for SLE-LN, SSc, andpSS PAH.
Single Center, Open Label, Non Randomized, Single Arm Clinical Study of Cord Blood CD19-BCMA CART Cell Therapy for Refractory Lupus Nephritis (SLE-LN), Systemic Sclerosis (SSc), and Primary Sjogren's Syndrome With Pulmonary Hypertension (pSS PAH)
Beijing GoBroad Hospital
45 participants
Mar 18, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
Approximately 3-5 days prior to umbilical cord blood CD19-BCMA CAR-T cell infusion, subjects are treated with FC regimen (fludarabine and cyclophosphamide) for lymphodepletion. CAR-T cell infusion are performed 48 h after completion of chemotherapy.
Locations(1)
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NCT06947473