Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-24 @ 6:26 PM
NCT ID:
NCT07241468
Eligibility Criteria:
Inclusion Criteria:
1. Age: ≥ 18 years old and ≤ 70 years old, male or female;
2. 2 B cell CD19 positive expression in peripheral blood detected by flow cytometry;
3. The functions of critical organs meet the following requirements:
1. Neutrophil count ≥ 1 x 10\^9/L, Hemoglobin ≥60g/L, platelets ≥ 50×109/L,
2. Liver function: ALT ≤ 3 x ULN,AST≤3 x ULN, TBIL≤1.5 x ULN,
3. Coagulation function: International standardized ratio (INR) ≤ 1.5x ULN, prothrombin time (PT) ≤1.5 x ULN,
4. Cardiac function: good hemodynamic stability, left ventricular ejection fraction (LVEF) ≥55%.
4. Female subjects of childbearing potential and male subjects whose partner is a female of childbearing potential are required to use medically approved contraception or abstain from sex for at least 6 months during and at least 6 months after the end of the study treatment period; female subjects of childbearing potential have had a negative serum HCG test within 7 days prior to study enrollment and are not lactating;
5. Voluntarily participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.
Specific inclusion criteria:
High-risk or relapsed/refractory primary membranous nephropathy
6. Primary membranous nephropathy diagnosed pathologically by renal biopsy;
7. Meets the clinical criteria for high-risk or recurrent/refractory membranous nephropathy, defined as:
Subjects at risk who meet any of the following criteria: a) estimated glomerular filtration rate (eGFR, CKD-EPI equation) \<60 mL/min/1.73m², and/or urine protein \>8g/day persisting for more than 6 months;b) normal GFR, urinary protein \>3.5 g/d, treated with ACEI/ARB for 6 months, urinary protein reduction \<50%, and serum albumin \<25 g/l or aPLA2R \>50 RU/mL;
Refractory membranous nephropathy subjects are defined as those who have shown poor response or resistance to previous immunosuppressive treatments (including corticosteroids and/or cytotoxic drugs, immunosuppressants and/or biologics), defined as persistent proteinuria ≥3.5g/day with a reduction of \<50% compared to baseline;
Recurrent membranous nephropathy is defined as a relapse (24-hour urinary protein ≥3.5 g) in subjects who have achieved complete or partial remission following treatment;
8. Subjects with relapsed/refractory MN and eGFR ≥ 45 mL/min/1.73 m2 during the screening period;
9. Primary IgA nephropathy pathologically confirmed by renal biopsy;
10. Subjects have medical records showing they have been on stable and maximally tolerated doses of either ACEI or ARB, as per local SOC and applicable guidelines, for at least 3 months preceding screening;
11. Subjects have been treated with hormones and/or cytotoxic drugs, immunosuppressants and/or biological agents (including but not limited to anti-CD20 monoclonal antibodies) for more than 6 months, and the 24-hour urine protein is ≥1.0 g; subjects with a rapidly progressive decline in kidney function (eGFR decreases by ≥50% within 3 months); or The subject relapsed after achieving complete remission/partial remission (CR/PR) following treatment (24-hour urine protein ≥1.0 g);
12. Estimated glomerular filtration rate (eGFR, CKD-EPI formula) ≥30 mL/min/1.73m2 at screening;
13. Meets the 2022 ACR/EULAR diagnostic criteria for ANCA-associated vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis;
14. ANCA-related antibodies positive (MPO-ANCA or PR3-ANCA positive);
15. Kidney biopsy pathology is consistent with ANCA-associated vasculitis renal damage;
16. Birmingham Vasculitis Activity Score (BVAS) ≥15 points (total score 63 points), indicating active vasculitis;
17. At least two abnormalities related to the kidneys in the BVAS score;
18. Subjects meeting the definition of relapsed/refractory: standard treatment is ineffective or disease activity recurs after remission. Definition of conventional treatment: using glucocorticoids (more than 1mg/kg/day) and cyclophosphamide, along with any one of the following immunomodulatory drugs for ≥3 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab, and thalidomide;
19. Estimated glomerular filtration rate (eGFR, CKD-EPI formula) ≥30 mL/min/1.73m2 at screening
Exclusion Criteria:
Subjects who meet any of the following common exclusion criteria or disease-specific exclusion criteria will not be eligible for this study
Common exclusion Criteria:
1. Subjects known to have allergic reactions, hypersensitivity, intolerance, or contraindications to CD19/BCMA universal CAR-T or any drug components that may be used in the study (including fludarabine, cyclophosphamide, and tocilizumab), or who have previously experienced severe allergic reactions;
2. The subject has or is suspected of having uncontrolled or treatable fungal, bacterial, viral, or other infections;
3. Subjects with central nervous system disorders caused by autoimmune diseases or non-autoimmune diseases (including epilepsy, psychiatric disorders, organic brain syndrome, cerebrovascular accidents, encephalitis, central nervous system vasculitis);
4. Subjects with more serious heart conditions, such as angina, myocardial infarction, heart failure, and arrhythmias;
5. Subjects with congenital immunoglobulin deficiency;
6. The subject has other malignant tumours (excluding non-melanoma skin cancer and carcinoma in situ of the cervix, bladder cancer, and breast cancer with disease-free survival of over 5 years);
7. Subjects with end-stage renal failure;
8. Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and have peripheral blood HBV DNA titres above the detection limit; subjects who are positive for hepatitis C virus (HCV) antibodies and peripheral blood HCV RNA; subjects who are positive for human immunodeficiency virus (HIV) antibodies; subjects who test positive for syphilis;
9. Subjects have mental illness and severe cognitive impairment;
10. Subjects who have participated in other clinical trials within 6 months prior to enrolment;
11. Female participants who are pregnant or planning to conceive;
12. Subjects with hypertension and diabetes uncontrolled by medication;
13. Researchers believe that there are other reasons why some subjects cannot be included in this study;
Specific exclusion Criteria:
Relapsed/Refractory Primary Membranous Nephropathy
14. Secondary membranous nephropathy (e.g., hepatitis B, systemic lupus erythematosus, drug-associated, malignancy-associated, etc.), or in combination with other renal diseases confirmed by renal biopsy;
Relapsed/Refractory IgA Nephropathy
15. Exclude secondary IgA nephropathy, including but not limited to: anaphylactic purpura, ankylosing spondylitis, systemic lupus erythematosus, desiccation syndrome, viral hepatitis, cirrhosis of the liver, rheumatoid arthritis, and mixed connective tissue disease; or in combination with other renal diseases confirmed by renal biopsy;
16. Crescentic nephritis (pathologic diagnosis of \>50% crescentic bodies), micrognathic nephropathy with IgA deposition, and other specific types of pathologic or clinical renal disease;
Relapsed/refractory ANCA-associated vasculitis kidney damage
17. Estimated glomerular filtration rate (eGFR) \<15 mL/min/1.73 m2;
18. If subjects have alveolar haemorrhage and requires invasive lung ventilation, the expected duration exceeds the screening time.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07241468
Study Brief:
Protocol Section:
NCT07241468