Safety and Efficacy of Second Infusion of FAP iCDC in End-stage Dilated Cardiomyopathy

Korábbi kezelés

• Known contraindications to the investigational product or study-related procedures.

Más betegség

• Presence of active infections at screening, including: Active hepatitis B infection with hepatitis B virus DNA >1000 copies/mL by PCR testing; Hepatitis C virus infection; Syphilis; Human immunodeficiency virus (HIV) infection; Uncontrolled systemic fungal, bacterial, viral, or other pathogenic infections.

Laborértékek

• Severe renal failure or requirement for renal dialysis, or serum creatinine >2.5 mg/dL.
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels greater than 5.0 times the upper limit of normal (ULN), or total bilirubin >3 mg/dL.

Egyéb

• Severe hemodynamic instability (e.g., shock).

• ≥18 years and ≤75 years of age, with a confirmed diagnosis of dilated cardiomyopathy.
• Patients who previously received a single infusion of immunosuppressive CAR-DC (iCDC) therapy and, at 6 months after the first treatment, failed to maintain improvement in cardiac function, with cardiac function declining to baseline levels prior to treatment. These patients should have persistent heart failure symptoms that cannot be adequately improved, with left ventricular ejection fraction (LVEF) <35%, New York Heart Association (NYHA) functional class III-IV, and INTERMACS profile 3-6.
• Able to verbally confirm understanding of the risks, benefits, and alternative treatment options of the second administration of iCDC therapy, and willing to participate in the study. The participant or his/her legal representative must provide written informed consent prior to enrollment.
• Hematocrit >30%, lymphocyte count >0.5 × 10⁹/L, and platelet count >60 × 10⁹/L.