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New treatment option for Rheumatoid Arthritis
Official title Exploratory Clinical Study of Anti-CD19/BCMA Universal CAR-T Cell Injection for the Treatment of Refractory Autoimmune Diseases
ClinicalTrials.gov ID: NCT07558850
What this study is testing
What is anti-CD19/BCMA-UCAR-T cells?
anti-CD19/BCMA-UCAR-T cells is an investigational medicine, being studied as a potential treatment for rheumatoid arthritis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA-UCAR-T cells in patients with autoimmune diseases. 36-72 patients are planned to be enrolled in the dose-escalation trial.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Common 1. Voluntarily sign an informed consent form, understand the study, and be willing and capable of completing all trial procedures.
- Aged 18 to 70 years, regardless of gender.
- At screening, the number of peripheral blood CD19-positive B cells determined by flow cytometry \> 5 cells/μL.
- For people previously treated with B-cell targeted therapy, peripheral blood B cell counts have returned to normal or above pre-treatment levels at...
- Complete blood counts within 7 days prior to lymphodepleting chemotherapy meet the following requirements in patients with Sjögren's disease (SjD)...
You likely can't join if
- Common Exclusion Criteria
- History of malignant tumors (excluding cured and completely resected basal cell carcinoma, squamous cell skin carcinoma or cervical carcinoma in situ...
- Complicated severe pulmonary diseases, including pulmonary hypertension graded ≥ Grade 3 per WHO functional classification, requirement for oxygen...
- Known allergy, hypersensitivity, intolerance or contraindication to CD19/BCMA CAR-NK cells or any investigational medicinal ingredients (including...
- Evidence of severe active viral, bacterial infection or uncontrolled systemic fungal infection at screening or baseline visit.
- Cardiac insufficiency classified as NYHA Class Ⅲ or Ⅳ according to New York Heart Association criteria (see Appendix).
See the full eligibility criteria
Who can join
- Common 1. Voluntarily sign an informed consent form, understand the study, and be willing and capable of completing all trial procedures.
- Aged 18 to 70 years, regardless of gender.
- At screening, the number of peripheral blood CD19-positive B cells determined by flow cytometry \> 5 cells/μL.
- For people previously treated with B-cell targeted therapy, peripheral blood B cell counts have returned to normal or above pre-treatment levels at the screening visit.
- Complete blood counts within 7 days prior to lymphodepleting chemotherapy meet the following requirements in patients with Sjögren's disease (SjD): Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L Hemoglobin (Hb) ≥ 80 g/L...
- people have adequate hepatic, renal, pulmonary and cardiac function at screening visit, defined as: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN) Total bilirubin...
- During the screening period, serum pregnancy test must be negative for fertile female people. Females who have undergone surgical sterilization or natural menopause for at least 2 years are considered non-fertile...
- Meet the 2010 ACR/EULAR classification diagnostic criteria, diagnosed with moderate to severe active rheumatoid arthritis, with a confirmed RA diagnosis for ≥ 6 months.
- Swollen joint count ≥ 6 (based on 66-joint assessment) and tender joint count ≥ 6 (based on 68-joint assessment) at screening.
- C-reactive protein (CRP) ≥ 10 mg/L or erythrocyte sedimentation rate (ESR) ≥ 28 mm/h at screening.
- Definition of EULAR refractory rheumatoid arthritis: Treatment failure: Patients received treatment in accordance with EULAR recommended guidelines, and failed to respond to ≥ 2 biological/targeted synthetic...
- Moderate or higher disease activity (DAS28-ESR \> 3.2 or CDAI \> 10);
- Clinical signs and/or symptoms indicative of active disease;
- Inability to taper glucocorticoids to ≤ 7.5 mg/day prednisone or equivalent dose;
- Rapid radiographic progression (increase in modified van der Heijde Sharp score ≥ 5 points within 1 year);
- Impaired quality of life secondary to RA, despite seemingly adequate disease control. Dermatomyositis (DM)
- Diagnosed with Dermatomyositis (DM) in accordance with the 2017 EULAR/ACR criteria for at least 24 weeks prior to informed consent (ICF) signing.
- Meet the classification criteria for refractory DM, and satisfy criterion ① plus any one of criteria ②-⑤:① Insufficient response to glucocorticoids (prednisone 1-2 mg/kg/day or equivalent dose of other corticosteroids)...
- Patients with anti-synthetase syndrome and positive anti-synthetase antibodies meet DM criteria and may be enrolled directly.
- Patients with immune-mediated necrotizing myopathy positive for SRP or HMGCR antibodies meet DM criteria and may be enrolled directly. Systemic Lupus Erythematosus (SLE)
- Diagnosed with adult systemic lupus erythematosus (SLE) in accordance with the 2019 EULAR/ACR SLE classification criteria for at least 12 weeks prior to signing the informed consent form (ICF).
- people with moderate to severe refractory SLE shall meet all of the following criteria: Positive antinuclear antibody (ANA) with a titer \>1:80 at screening visit; or anti-double stranded DNA antibody level above the...
- people receiving hematopoietic growth factor supportive therapy, including erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF) and...
- Meet the 2013 ACR/EULAR classification criteria for systemic sclerosis, with disease duration ≤ 60 months.
- Positive for antinuclear antibody (ANA) or any SSc-specific autoantibody.
- Modified Rodnan Skin Score (mRSS) ≥ 15 (full score: 51).
- Meet the definition of refractory disease:
- Significant progressive involvement of skin and visceral organs; ② No obvious disease remission after more than 3 months of combined or sequential treatment with glucocorticoids and/or cyclophosphamide, plus one or more...
What rules you out
- Common Exclusion Criteria
- History of malignant tumors (excluding cured and completely resected basal cell carcinoma, squamous cell skin carcinoma or cervical carcinoma in situ with a disease-free interval of at least 5 years post resection), or...
- Complicated severe pulmonary diseases, including pulmonary hypertension graded ≥ Grade 3 per WHO functional classification, requirement for oxygen therapy via oxygen reservoir mask, non-invasive or invasive mechanical...
- Known allergy, hypersensitivity, intolerance or contraindication to CD19/BCMA CAR-NK cells or any investigational medicinal ingredients (including fludarabine, cyclophosphamide and tocilizumab), or history of severe...
- Evidence of severe active viral, bacterial infection or uncontrolled systemic fungal infection at screening or baseline visit.
- Cardiac insufficiency classified as NYHA Class Ⅲ or Ⅳ according to New York Heart Association criteria (see Appendix).
- Congenital heart disease prior to screening, history of acute myocardial infarction within 6 months, severe arrhythmia (including multifocal frequent supraventricular tachycardia, ventricular tachycardia, etc.)...
- Active or uncontrolled infection requiring parenteral antimicrobial therapy at screening or baseline visit.
- Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral HBV DNA level above upper limit of normal; positive HCV antibody with peripheral HCV RNA level above upper limit of...
- History of severe herpes infection such as herpes encephalitis, ocular herpes or disseminated herpes; signs of herpes or varicella-zoster virus infection (particularly varicella and herpes zoster) within 12 weeks prior...
- Active tuberculosis, history of active tuberculosis, or negative interferon-gamma release assay for tuberculosis infection not achieved during screening period.
- History of epilepsy or other active central nervous system disorders.
- people with acquired or congenital immunodeficiency diseases.
- Any clinically significant cardiac, endocrine, hematological, hepatic, immune, metabolic, urinary, pulmonary, neurological, dermatological, psychiatric, renal disorders or major medical history that may interfere with...
- Solid organ transplantation or hematopoietic stem cell transplantation within 3 months prior to screening; acute graft-versus-host disease (GVHD) Grade ≥2 within 2 weeks prior to screening.
- Administration of live vaccines within 4 weeks prior to screening.
- Receipt of the following treatments within specified time windows before baseline visit: B-cell depleting therapy within 26 weeks Anti-CD40 monoclonal antibody, belimumab, abatacept, anti-tumor necrosis factor-α...
- Participation in other clinical trials within 3 months, excluding people confirmed not to receive investigational drugs or devices.
- Any conditions that, in the investigator's opinion, may elevate subject risk or confound trial outcomes. Specific Exclusion Criteria Relapsed/Refractory Rheumatoid Arthritis (RA)
- ACR functional class Grade 4 for rheumatoid arthritis. Dermatomyositis (DM)
- Paraneoplastic myositis, defined as myositis diagnosed within 2 years following cancer diagnosis, or people categorized as high-risk for malignancy.
- people with overlap syndrome (excluding overlap with Sjögren's syndrome), connective tissue disease-associated DM other than primary DM, inclusion body myositis, polymyositis, or drug-induced myopathy.
- people with severe systemic musculoskeletal disorders other than DM, which interfere with adequate investigator assessment of disease activity. Systemic Lupus Erythematosus (SLE)
- Renal pathological diagnosis of Class V lupus nephritis (excluding Class III or IV lupus nephritis complicated with Class V lupus nephritis); active nephritis requiring treatment with protocol-prohibited medications, or...
- Concurrent rheumatic autoimmune diseases other than SSc, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, mixed connective tissue disease, polymyositis and dermatomyositis, as determined...
- Non-SSc cutaneous lesions that impair accurate investigator evaluation of disease activity.
- History of scleroderma renal crisis occurring within 2 years prior to screening visit.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.