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

StatusRecruiting
PhasePhase 1/2
Started2026-03-18
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 3, 2026 (before its estimated July 1, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2026-03-01
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Completion date2026-07-31→2027-12-31
Start date2025-09-18→2026-03-18
Study sites0→1
2025-09-15
Study Status v3
Start date2025-05-18→2025-09-18
2025-05-15
Study Status v2
Start date2025-04-18→2025-05-18
2025-04-25
Study Identification, Study Status, Conditions v1
Study title-62 characters
Single Center, Open Label, Non Randomized, Single Arm Clinical Study ofUmbilical Cord Blood CD19-BCMA CART Cell Therapy for SLE-LN, SSc, andpSS PAH.
2025-04-21
Original filing
Beijing GoBroad Hospital
35 trials monitored
See 2 trials at risk
Hypertension
1,786 trials monitored
See 77 trials at risk
Lupus (SLE)
648 trials monitored
See 25 trials at risk
Scleroderma
302 trials monitored
See 9 trials at risk
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.
Trial Details
NCT Number NCT06947473
Lead Sponsor Beijing GoBroad Hospital
Conditions Refractory Lupus Nephritis, Systemic Sclerosis, Primary Sjogren's Syndrome Combined With Pulmonary Hypertension
Enrollment 45 participants
Start Date 2026-03-18
Primary Completion 2026-07-01 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-03