RecruitingPhase 1Phase 2NCT06947473

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)


Sponsor

Beijing GoBroad Hospital

Enrollment

45 participants

Start Date

Mar 18, 2026

Study Type

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

Min Age: 6 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing CAR-T cell therapy made from umbilical cord blood — rather than the patient's own cells — for people with severe autoimmune diseases (lupus nephritis, systemic sclerosis, or Sjögren's-related pulmonary arterial hypertension) that haven't responded to other treatments. **You may be eligible if...** - You are between 3 and 65 years old - You have refractory lupus nephritis confirmed by biopsy showing active, proliferative disease (type III or IV) - OR you have systemic sclerosis or Sjögren's-related pulmonary hypertension that hasn't responded to standard treatment - Your disease was confirmed within the last 6 months by biopsy or other criteria - You have failed multiple standard immunosuppressive treatments **You may NOT be eligible if...** - Your condition does not meet the specific diagnostic criteria - You have active, serious infections - Your organ function is too impaired to receive cell therapy safely - You have received certain prior immune or cell therapies Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGumbilical cord blood CD19-BCMA CAR-T cells infusion

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)

Beijing GoBroad Hospital

Beijing, Beijing Municipality, China

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NCT06947473


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