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CD19-BCMA CART Cell Therapy for Refractory SLE-LN, SSc, and pSS-PAH | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

NCT06947460•Beijing GoBroad Hospital

View on ClinicalTrials.gov

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 CD19-BCMA CAR T cell therapy. The primary objective is to prospectively assess the safety of CD19-BCMA CAR T cell therapy in patients with SLE-LN, SSc, and pSS-PAH. The primary endpoint is the type and incidence of dose-limiting toxicity (DLT) within 28 days after CD19-BCMA CAR T cell infusion.

Eligibility

Age

10 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Definition: Failure to achieve induction remission after 3 to 6 months of treatment with at least one immunosuppressive agent (including glucocorticoids, cyclophosphamide \[CTX\], tacrolimus, mycophenolate mofetil, and cyclosporine), accompanied by no reduction (or worsening) in proteinuria or persistent positive autoantibodies.
•Diagnostic criteria : According to the 2019 American College of Rheumatology (ACR) criteria, and confirmed by renal biopsy in accordance with the 2018 International Society of Nephrology (ISN)/Renal Pathology Society (RPS) criteria (Appendix 3), were diagnosed with active, proliferative lupus nephritis (LN), including Class III or IV \[excluding Class III (C), IV-S (C), and IV-G (C)\], or combined Class III/IV with Class V.
•1. Male or female, aged 10-65 years;
•2. Meeting the 2019 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Classification Criteria for Systemic Lupus Erythematosus (Appendix 4);
•3. The ANA result is positive which means ANA titer≥ 1:80 (based on the equivalent detection results by Hep-2 immunofluorescence assay or enzyme immune assay), and/or according to the detection results from center laboratory, during the screening visit,the anti dsDNA serum antibody test is positive (based on ELISA assay, ≥30 IU/mL);
•4. B cell CD19+ expression, and stop using immunosuppressant more than one week.
•5. The lymphocyte count in the subject's blood routine \>0.5×109/L, and no contraindications for cell collection;
•6. No serious allergic constitution;
•7. ECOG score: 0-2:
•8. Expected survival ≥90 days:
+29 more criteria

Exclusion Criteria

•An individual who meets any of the following criteria will be excluded from participation in this study:
•1\. Refractory Lupus Nephritis (LN):
•1. Intracranial hypertension or disorder of consciousness;
•2. Symptomatic heart failure or severe arrhythmia;
•3. Symptoms of severe respiratory failure;
•4. Complicated with other types of malignant tumors;
•5. Diffuse intravascular coagulation;
•6. Suffering from septicemia or other uncontrollable infections;
•7. Patients with uncontrollable diabetes and other endocrine diseases;
•8. Severe mental disorders;
+42 more criteria

Locations (1)

北京高博医院

Beijing, China,Beijing, China

Key Dates

Start Date

April 18, 2025

Primary Completion Date

July 1, 2026

Completion Date

July 31, 2026

Last Updated

March 3, 2026

Enrollment

ESTIMATED participants

Conditions

Refractory Lupus NephritisSystemic SclerosisPrimary Sjogren's Syndrome Combined With Pulmonary Hypertension

Interventions

CD19-BCMA CAR-T cells infusion

DRUG

Contacts

ZHOU

CONTACT

86+18511772961 zhousn@gobroadhealthcare.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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