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New treatment option for Systemic Sclerosis (SSc)
Official title Anti-CD19 IL-10/IL15 CAR-NK Cells in Refractory/Relapsed Autoimmune Diseases
ClinicalTrials.gov ID: NCT06614270
What this study is testing
What is Anti-CD19 IL-10/IL15 CAR-NK?
Anti-CD19 IL-10/IL15 CAR-NK is an investigational medicine, being studied as a potential treatment for systemic sclerosis (ssc).
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
- This study is a single-center, open-label, single-arm, dose-escalation trial. The aim of this study is to investigate the safety and efficacy of Anti-CD19 IL-10/IL15 CAR-NK cells in patients with refractory/relapsed autoimmune diseases, including systemic lupus erythematosus, systemic sclerosis, idiopathic inflammatory myositis, ANCA associated vasculitis, sjogren syndrome, and antiphospholipid syndrome.
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 65
You may be able to join if
- Common inlcusion Criteria:
- Age 18-65 years old, male or female;
- Routine blood count: hemoglobin ≥60g/L, white blood cell count ≥ 2.5×109/L, neutrophil count ≥1.0×109/L (no colony-stimulating factor treatment...
- Liver function: ALT ≤3×ULN, AST≤3×ULN, TBIL≤1.5×ULN;
- Coagulation function: international normalized ratio (INR) \< 1.5×ULN, prothrombin time (PT) \<1.5×ULN;
You likely can't join if
- Combined with other connective tissue diseases;
- Involvement of important organs: heart (individuals with more severe heart disease, such as angina, myocardial infarction, heart failure, and...
- Abnormal hepatitis B or hepatitis C test indicating active infection or chronic infection, including positive HBsAg or HBcAb test and positive...
- Have active tuberculosis or latent tuberculosis;
- Human immunodeficiency virus (HIV) serology positivity or known history of HIV infection;
- Presence of any known serious active infection (including bacterial, viral, fungal, etc.), including those requiring hospitalization or intravenous...
See the full eligibility criteria
Who can join
- Common inlcusion Criteria:
- Age 18-65 years old, male or female;
- Routine blood count: hemoglobin ≥60g/L, white blood cell count ≥ 2.5×109/L, neutrophil count ≥1.0×109/L (no colony-stimulating factor treatment within 2 weeks before examination);
- Liver function: ALT ≤3×ULN, AST≤3×ULN, TBIL≤1.5×ULN;
- Coagulation function: international normalized ratio (INR) \< 1.5×ULN, prothrombin time (PT) \<1.5×ULN;
- Cardiac function: good hemodynamic stability;
- Female people of childbearing age must have a negative pregnancy test and agree to use effective contraception during the trial;
- Voluntarily participate in this study and sign the informed consent form, agreeing to participate in the follow-up as required. SLE Enrollment Criteria:
- patients meet the classification criteria of SLE;
- Refractory or relapsed cases classified as non-response to standard therapy or disease recurrence after remission. Standard treatment is defined as therapy with at least three agents, including glucocorticoids at a dose...
- Patients who meet the SSc classification criteria of the 2013 ACR/EULAR and have a diagnosis of systemic sclerosis;
- the patient\'s disease duration ≤ 60 months (defined as the onset of the first non-Raynaud\'s symptoms);
- Patient-modified Rodnan skin score (mRSS) ≥10 at the baseline visit; or active interstitial lung disease (ILD): ground-glass opacity on high-resolution computed tomography (HRCT), pulmonary function suggestive of forced...
- A or B needs to be met: A. Refractory or relapsed cases classified as non-response to standard therapy or disease recurrence after remission. Standard treatment is defined as the use of glucocorticoids and...
- Diagnosis according to the 2017 EULAR/ACR classification criteria for inflammatory myopathies, including dermatomyositis (DM), polymyositis (PM), antisynthetase antibody syndrome (ASS), and immune-mediated necrotizing...
- patients with muscle involvement with a manual strength test-8 (MMT-8) score less than 142 and at least 2 abnormalities in the following 5 core assessments: Physician Global Assessment (PhGA), Patient Global Assessment...
- Positive myositis-specific antibodies;
- A or B needs to be met: A. Relapsed or refractory patients: relapsed or reactive after remission. Definition of conventional treatment: use of glucocorticoids (more than 1 mg/kg/d) and cyclophosphamide and any one or...
- Meets the 2022 ACR/EULAR ANCA-ASSOCIATED VASCULITIS CLASSIFICATION CRITERIA, INCLUDING MICROSCOPIC POLYANGIITIS (MPA), GRANULOMATOSIS WITH POLYANGIITIS (MPA);
- Positive PR3-ANCA or MPO-ANCA (either previous or current positive);
- Birmingham Vasculitis Activity Scale (BVAS) score of ≥ 15 points, and at least 1 major item caused by active vasculitis, or at least 3 non-major items, or at least renal involvement hematuria, proteinuria;
- estimated glomerular filtration rate (eGFR) ≥15 mL/minute/1.73 m2 (MDRD method);
- Definition of refractory/relapsed: Conventional treatment that remains ineffective for more than 6 months, or disease recurrence after remission. Conventional treatment definition: use of glucocorticoids (more than 1...
- Meet the 2002 European and American Consensus Group (AECG) standards or the 2016 ACR/EULAR Primary Sjögren\'s Syndrome (pSS) classification criteria;
- positive anti-SSA/Ro-60 antibody;
- Definition of disease activity: EULAR Sjögren\'s Syndrome Disease Activity Index (ESSDAI) score ≥ 5;
- Definition of recurrence/refractory: Conventional treatment that remains ineffective for more than 6 months, or disease recurrence after remission. Conventional treatment is defined as the use of glucocorticoids (\>1...
- Primary antiphospholipid syndrome meeting the 2006 Sydney criteria;
- Medium to high titer phospholipid antibody (aPL) positive: lupus anticoagulant (LA), IgG or IgM anti-β2 glycoprotein 1 antibody (anti-β2-GP1) or anticardiolipin antibody (aCL), at least 2 or more times positive, with an...
- A or B needs to be met: A. Definition of refractory/relapsed: recurrent thrombosis with standard therapy with warfarin or other vitamin K antagonist coagulation (INR maintained within the range required for treatment)...
What rules you out
- Combined with other connective tissue diseases;
- Involvement of important organs: heart (individuals with more severe heart disease, such as angina, myocardial infarction, heart failure, and arrhythmias), kidney (eGFR \ 3×ULN, AST\>3×ULN, TBIL \>1.5×ULN), lung...
- Abnormal hepatitis B or hepatitis C test indicating active infection or chronic infection, including positive HBsAg or HBcAb test and positive hepatitis C antibody;
- Have active tuberculosis or latent tuberculosis;
- Human immunodeficiency virus (HIV) serology positivity or known history of HIV infection;
- Presence of any known serious active infection (including bacterial, viral, fungal, etc.), including those requiring hospitalization or intravenous antibiotic therapy within 4 weeks prior to screening and oral...
- Patients with primary or secondary immunodeficiency;
- IgA deficiency (\<10 mg/dL) or IgG deficiency (\<400 mg/dL);
- Receiving other investigational drug treatment or participating in any other drug trial within 3 months before screening;
- History of documented and confirmed malignancy within 5 years prior to screening, with the exception of basal cell carcinoma of the skin or carcinoma in situ of the cervix that has been appropriately treated or resected;
- Patients who are pregnant, breastfeeding, or planning a recent pregnancy, or who are unwilling to use a reliable contraceptive method of contraception for the duration of the study;
- Those who have been allergic to human or murine proteins and monoclonal antibodies in the past;
- Received live vaccine or live attenuated vaccine within 4 weeks prior to randomization;
- Patients who are not expected to comply with the requirements of the protocol or are not expected to complete the trial as planned (such as those with psychiatric disorders, history of alcoholism, drug or other...
- Other conditions that the investigator considers the patient not suitable to enter the trial. Systemic Sclerosis Exclusion Criteria:
- Localized cutaneous SSc;
- the duration of the disease is greater than 5 years (defined as the onset of the first non-RP symptom);
- SSc-like syndrome related to environmental factors, such as vinyl chloride, bleomycin, etc.;
- Any history of scleroderma renal crisis;
- intermediate- and high-risk pulmonary hypertension;
- Active antral vasodilation. Idiopathic Inflammatory myopathy exclusion criteria:
- drug-induced myopathy;
- inclusion body myositis;
- Tumor-associated myositis (myositis occurring within 2 years of diagnosis of tumor). ANCA-associated vasculitis exclusion criteria:
- alveolar hemorrhage, requiring invasive lung ventilation, which is expected to last longer than the screening time;
- Need for dialysis or plasmapheresis during screening;
- Have undergone a kidney transplant. Sjögren\'s syndrome exclusion criteria:
- Combined with liver cirrhosis;
- Combined with aplastic anemia (AA), myelodysplastic syndrome (MDS) or other myeloproliferative disorders (MPD);
- drug-induced thrombocytopenia;
- Thrombotic thrombocytopenic purpura (TTP)/microthrombotic vascular disease (TMA). Antiphospholipid syndrome exclusion criteria:
- Obstetric APS;
- APS incorporates other CTDs;
- APS involves the nervous system.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, 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 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, 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.