RecruitingPhase 1Phase 2NCT06947460

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

CD19-BCMA CART Cell Therapy for Refractory Systemic Lupus Erythematosus Nephritis (SLE-LN), Systemic Sclerosis (SSc), and Primary Sjogren Syndrome Combined With Pulmonary Artery Hypertension (pSS-PAH): a Single-center, Open, Non-randomized, Single-arm Clinical Study

Sponsor

Beijing GoBroad Hospital

Enrollment

45 participants

Start Date

Apr 18, 2025

Study Type

INTERVENTIONAL

Conditions

Refractory Lupus Nephritis Systemic Sclerosis Primary Sjogren's Syndrome Combined With Pulmonary Hypertension Other Autoimmune Diseases (AID)

Summary

This is a single-center, open-label, non-randomized, single-arm clinical trial. Patients with refractory lupus neritis (SLE-LN), systemic sclerosis (SSc), primary Sjogren syndrome combined with pulmonary artery hypertension (pSS-PAH) and other autoimmune diseases (AID) receive CD19-BCMA CAR T cell therapy. Phase I (Dose-Escalation/Dose-De-escalation Phase)：The primary objective is to prospectively assess the safety of CD19-BCMA CAR T cell therapy in patients with SLE-LN, SSc, pSS-PAH and other autoimmune diseases (AID).Phase I (Dose-Escalation/Dose-De-escalation Phase)：Primary Endpoint: Safety, tolerability, and determination of the optimal biological dose (OBD) and the Phase II recommended dose (RP2D) in patients with SLE-LN, SSc, pSS-PAH, and other autoimmune diseases (AID).Phase II (Dose-Expansion Phase):Overall remission rate (ORR) \[Time Frame: 90,180 Days\]

Eligibility

Min Age: 10 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an experimental immune cell therapy — called CD19-BCMA CAR-T cell therapy — for people with severe autoimmune diseases that have not responded to standard treatments: specifically lupus nephritis (kidney inflammation from lupus), systemic sclerosis (scleroderma), and pulmonary arterial hypertension associated with primary Sjögren's syndrome. **You may be eligible if...** - You have refractory lupus nephritis (kidney disease from lupus that hasn't improved after at least 3–6 months of immunosuppressive treatment) - OR you have systemic sclerosis or Sjögren's-related pulmonary arterial hypertension that hasn't responded to standard medications - You meet the relevant diagnostic criteria for your condition - Your autoimmune disease has not responded to multiple standard treatments **You may NOT be eligible if...** - Your disease is not one of the three targeted conditions - You have active severe infections - You have significant organ failure beyond what is caused by your autoimmune disease - You have received certain immune therapies recently 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

DRUGCD19-BCMA CAR-T cells infusion

Approximately 3-5 days prior to 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.