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

NCT06947460 | Recruiting Phase 1 DMC

• 1 other identifier: BJGBYY-IIT-LCYJ-2025-024
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Refractory Lupus Nephritis; Systemic Sclerosis; Primary Sjogren's Syndrome Combined With Pulmonary Hypertension

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity (DLT)

  Incidence and type of dose-limiting toxicity(DLT) within 28 days of CD19-BCMA CAR-T infusion.

  28 days

• Adverse events (AEs)

  Total number, incidence and severity of adverse events (AEs) within 30 days of CD19-BCMA CAR-T infusion

  30 days

Secondary Outcomes (2)

• Overall remission rate (ORR)

  90,120 Days

• Serious adverse event（SAE)

  from 30 days to 2 years

Study Arms (1)

CD19-BCMA CART therapy.

EXPERIMENTAL

Patients were treated with CD19-BCMA CART

Drug: CD19-BCMA CAR-T cells infusion

Interventions

CD19-BCMA CAR-T cells infusion DRUG

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.

CD19-BCMA CART therapy.

Eligibility Criteria

• Age: 10 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Male or female, aged 10-65 years;
• Meeting the 2019 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Classification Criteria for Systemic Lupus Erythematosus (Appendix 4);
• 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);
• B cell CD19+ expression, and stop using immunosuppressant more than one week.
• The lymphocyte count in the subject's blood routine \>0.5×109/L, and no contraindications for cell collection;
• No serious allergic constitution;
• ECOG score: 0-2:
• Expected survival ≥90 days:
• Subjects and/or their guardian can understand and sign the informed consent form.
• \. SSc: Patients who meet all the following requirements can be enrolled in the group.
• Patients or their legal representatives sign the informed consent form;
• Male or female, aged 18-65 years.
• According to the SSc classification criteria proposed by American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR), chose the highest score under the same condition. If the score ≥9, it can be classified SSc. (Appendix 5)

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• \. Refractory Lupus Nephritis (LN):
• Intracranial hypertension or disorder of consciousness;
• Symptomatic heart failure or severe arrhythmia;
• Symptoms of severe respiratory failure;
• Complicated with other types of malignant tumors;
• Diffuse intravascular coagulation;
• Suffering from septicemia or other uncontrollable infections;
• Patients with uncontrollable diabetes and other endocrine diseases;
• Severe mental disorders;
• Obvious and active intracranial lesions were detected by cranial magnetic resonance imaging (MRI);
• Have received organ transplantation (excluding bone marrow transplant);
• Reproductive-aged female patients with positive blood human chorionic gonadotropin (HCG) test;
• Positive screening for hepatitis (HBV and HCV included), HIV and syphilis;
• The subject is unable to undergo PBMC collection, nor are there cryopreserved PBMCs available for CAR-T cell manufacturing;

Sponsors & Collaborators

• Beijing GoBroad Hospital: lead

Study Sites (1)

北京高博医院

Beijing, China,Beijing, 102200, China

RECRUITING

MeSH Terms

Conditions

Lupus Nephritis; Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin Diseases

Central Study Contacts

ZHOU

CONTACT

86+18511772961; zhousn@gobroadhealthcare.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the department of Immunotherapy for Hematopoietic Malignancies

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: April 27, 2025
• Study Start: April 18, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Locations

CN (1)