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:
2025-12-25 @ 12:46 AM
Ignite Modification Date:
2025-12-25 @ 12:46 AM
NCT ID:
NCT07193667
Eligibility Criteria:
Inclusion Criteria:
* age 18-65 years (including threshold) and gender;
* positive expression of CD19 in peripheral blood B cells as determined by flow cytometry;
* the function of vital organs meets the following requirements:
1. Bone marrow function needs to meet the following requirements: a. White blood cell count ≥3×109/L; b. Neutrophil count ≥1×109/L (no colony-stimulating factor treatment within 2 weeks prior to the examination); c. Hemoglobin ≥60g/L;
2. Liver function: ALT≤3×ULN (except for elevated ALT caused by inflammatory myopathy); AST≤3×ULN (except for AST elevation caused by inflammatory myopathy); TBIL≤1.5×ULN (except for Gilbert's disease).
TBIL≤1.5×ULN (except Gilbert's syndrome, total bilirubin≤3.0×ULN);
3. Renal function: creatinine clearance (CrCl) ≥ 30 ml/minute (Cockcroft/Gault formula, except for disease-induced decline in CrCl);
4. Coagulation: international normalized ratio (INR) ≤ 1.5 x ULN, prothrombin time (PT) ≤ 1.5 x ULN.
5. Cardiac function: hemodynamic stability;
* female subjects of childbearing potential and male subjects with a partner of childbearing potential are required to use medically approved contraception or be abstinent from sexual intercourse for at least 6 months during and after study treatment; female subjects of childbearing potential must have had a negative serum HCG test within 7 days prior to study enrollment and must not be breastfeeding;
* Voluntarily participate in this clinical study and sign the informed consent form, good compliance and cooperate with follow-up visits.
* Specific inclusion criteria:
* Relapsed refractory systemic lupus erythematosus.
* meets the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for SLE;
* have a Disease Activity Score SLEDAI⁃2000 ≥ 6; and have at least one British Isles Lupus Assessment Group Index (BILAG-2004) Category A (severe manifestations) or two Category B (moderate manifestations) organ scores, or both; or have a Disease Activity Score SLEDAI-2000 ≥ 8;
* Definition of relapse-refractory: failure of conventional treatment for more than 6 months or recurrence of disease activity after remission.
* Relapsing Refractory/Progressive Diffuse Systemic Sclerosis
* meets the 2013 ACR's classification criteria for systemic sclerosis consistent with a diffuse presentation
* is positive for antibodies related to systemic sclerosis;
* diffuse cutaneous sclerosis manifestations or active interstitial lung disease (HRCT suggestive of ground-glass exudates);
* definition of relapsing-refractory: failure of conventional treatment for more than 6 months or recurrence of disease activity after remission.
* Definition of Progressive: Rapid cutaneous progression (\>25% increase in mRSS); or pulmonary progression (10% decrease in FVC, or \>5% decrease in FVC with 15% decrease in DLCO).
* Note: It is sufficient if one of Articles 4 and 5 is fulfilled.
* Relapsed refractory/progressive inflammatory myopathy
* meets the 2017 EULAR/ACR classification criteria for inflammatory myopathies (including DM , PM, ASS, and NM);
* is positive for antibodies to myositis;
* in those with muscle involvement, an MMT-8 score of less than 142 and abnormal findings on at least two of the following five core measurements (PhGA, PtGA, or Extramuscular Disease Activity Score ≥2; Total HAQ Score ≥0.25); Myosin level 1.5 times the upper limit of the normal range); or MMT-8 ≥142 in the presence of active interstitial lung disease (HRCT suggestive of ground-glass exudates);
* Definition of relapse refractory: failure of conventional treatment for more than 6 months or recurrence of disease activity after remission.
* Definition of progressive: the presence of exacerbation of myositis or rapidly progressive interstitial pneumonia.
* Note: It is sufficient if one of Articles 4 and 5 is fulfilled.
* Relapsed Refractory/Progressive Immune Thrombocytopenia
* meets the 2019 American Society of Hematology (ASH) classification criteria for immune thrombocytopenia;
* have bone marrow morphology characterized by increased or normal megakaryocytes with impaired maturation;
* exclude other secondary thrombocytopenia
* Definition of recurrent refractory: a patient who fails to achieve a satisfactory outcome after first-line standard therapy (e.g., glucocorticoids), including a full dose and course of therapy, i.e., platelet counts that cannot be maintained at a safe level (generally considered to be platelet counts \> 30 × 10⁹ /L and without overt bleeding symptoms).
* Definition of progressive: a sustained decline in platelet count over the course of the disease, or a progressive worsening of bleeding symptoms, which may be accompanied by signs such as splenomegaly, and a progressively worse response to conventional therapy.
* Note: It is sufficient if one of Articles 4 and 5 is fulfilled.
Exclusion Criteria:
* A history of severe drug allergies or sensitivities;
* the presence or suspicion of fungal, bacterial, viral or other infections that are uncontrolled or require treatment
* persons with central nervous system disorders caused by ADs or not caused by ADs.
* those with intolerable cardiac function;
* subjects with congenital immunoglobulin defects.
* history of malignant tumors within the last five years.
* end-stage renal failure;
* subjects with positive Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb) and peripheral blood HBV DNA titer higher than the upper limit of the test; subjects with positive antibody to Hepatitis C virus (HCV) and peripheral blood HCV RNA; subjects with positive antibody to Human Immunodeficiency Virus (HIV); and subjects with a positive test for Syphilis;
* mental illness and severe cognitive impairment;
* have participated in other clinical trials within 3 months prior to enrollment;
* immunosuppressants or biologics with a therapeutic effect for the indication within five half-lives prior to enrollment
* women who are pregnant or intend to become pregnant;
* subjects who, in the opinion of the investigator, have other reasons for not being included in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07193667
Study Brief:
Protocol Section:
NCT07193667