CAR-DC for End-Stage IPF

Korábbi kezelés

• History of acute exacerbation of IPF within 4 weeks prior to screening or during the screening period.
• Any contraindication to the investigational product or study procedures.

Más betegség

• 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.
• Presence of significant active infection.
• Significant history of infectious diseases.
• 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.
• Known hypersensitivity to any component of the immunosuppressive CAR-DC cell product.
• History of pulmonary embolism (PE), deep vein thrombosis (DVT), or recurrent thromboembolic events.

Laborértékek

• History of severe renal failure requiring renal dialysis, or serum creatinine level >2.5 mg/dL.
• 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.
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels >5.0 times the upper limit of normal (ULN), or total bilirubin >3 mg/dL.

Életkor

• 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.

Egyéb

• Pregnancy or lactation.

• Aged between 18 and 75 years, inclusive, with a diagnosis of idiopathic pulmonary fibrosis (IPF).
• 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.
• Evidence of disease progression (worsening pulmonary fibrosis and declining lung function) despite treatment with standard therapies such as pirfenidone, nintedanib, or other appropriate regimens.
• Meets at least one criterion indicating eligibility for lung transplantation due to interstitial lung disease, while not consenting to a transplant. The criteria include:
• A decline in forced vital capacity (FVC) ≥10% over a 6-month follow-up period.
• A decline in diffusing capacity of the lungs for carbon monoxide (DLCO) ≥10% of predicted value over 6 months.
• 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.
• Presence of pulmonary hypertension (PH) confirmed by right heart catheterization or transthoracic echocardiography.
• Hospitalization due to respiratory functional decline, pneumothorax, or acute exacerbation.
• 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.