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:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07329959
Eligibility Criteria:
Inclusion Criteria:
1\. Aged between 18 and 75 years, inclusive, with a diagnosis of idiopathic pulmonary fibrosis (IPF).
2\. Ability to verbally confirm understanding of the risks, benefits, and alternative treatments associated with immunosuppressive CAR-DC therapy. Provision of written informed consent by the patient or their legally authorized representative prior to participation.
3\. Evidence of disease progression (worsening pulmonary fibrosis and declining lung function) despite treatment with standard therapies such as pirfenidone, nintedanib, or other appropriate regimens.
4\. Meets at least one criterion indicating eligibility for lung transplantation due to interstitial lung disease, while not consenting to a transplant. The criteria include:
1. A decline in forced vital capacity (FVC) ≥10% over a 6-month follow-up period.
2. A decline in diffusing capacity of the lungs for carbon monoxide (DLCO) ≥10% of predicted value over 6 months.
3. Six-minute walk test results showing oxygen saturation \<88%, a distance walked \<250 meters, or a decline of \>50 meters in distance over 6 months.
4. Presence of pulmonary hypertension (PH) confirmed by right heart catheterization or transthoracic echocardiography.
5. Hospitalization due to respiratory functional decline, pneumothorax, or acute exacerbation.
5\. No prior cellular immunotherapy within the last 3 months. 6. Hematological parameters meeting the following thresholds: hematocrit \>30%, lymphocyte count \>0.5 × 10⁹/L, and platelet count \>60 × 10⁹/L.
Exclusion Criteria:
1. History of acute exacerbation of IPF within 4 weeks prior to screening or during the screening period.
2. Presence of interstitial lung disease (ILD) other than IPF, including but not limited to: other forms of idiopathic interstitial pneumonia; ILD associated with fibrogenic agents, environmental exposures, or drug toxicity; other occupational lung diseases; granulomatous lung diseases; pulmonary vascular diseases; or ILD related to systemic diseases (e.g., vasculitis, infections such as tuberculosis, connective tissue diseases). Cases with uncertain diagnosis require serological testing and/or multidisciplinary team review for confirmation.
3. Presence of significant active infection.
4. History of malignancy, except for malignancies treated with curative intent and with no recurrence for ≥5 years, resected basal cell or squamous cell skin carcinoma, carcinoma in situ of the cervix, or resected colonic polyps.
5. Significant history of infectious diseases.
6. Presence of psychiatric illness or other conditions that would compromise the patient's ability to cooperate with study requirements, comply with treatment, or undergo monitoring.
7. Known hypersensitivity to any component of the immunosuppressive CAR-DC cell product.
8. History of severe renal failure requiring renal dialysis, or serum creatinine level \>2.5 mg/dL.
9. Any contraindication to the investigational product or study procedures.
10. Pregnancy or lactation.
11. History of pulmonary embolism (PE), deep vein thrombosis (DVT), or recurrent thromboembolic events.
12. Uncorrected thrombocytopenia (platelet count \<50,000/μL) or systemic coagulopathy (INR \>2.5 or aPTT \>2.5 times the control value in the absence of anticoagulant therapy), or active bleeding with uncorrectable coagulopathy.
13. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels \>5.0 times the upper limit of normal (ULN), or total bilirubin \>3 mg/dL.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07329959
Study Brief:
Protocol Section:
NCT07329959