This study aims to evaluate the safety and preliminary efficacy of a second administration of fibroblast activation protein (FAP)-targeted immunosuppressive chimeric antigen receptor dendritic cells (CAR-DC) in patients with end-stage dilated cardiomyopathy.
Previous clinical research has shown that single-dose CAR-DC therapy is safe and may provide clinical benefit. However, some patients experience recurrent worsening of heart function after initial treatment. This study will assess whether a second CAR-DC infusion is safe and whether it can further improve cardiac function in this patient population.
≥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.
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.
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.
Severe hemodynamic instability (e.g., shock).
Single group
FAP immunosuppressive CAR-DC
Biological/VaccineEach subject receive FAP immunosuppressive CAR-DC by intravenous infusion
The proportion of subjects with Dose-limiting toxicity (DLT)
The proportion of participants with treatment-related adverse events as assessed by CTCAE v5.0
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of iCDC treatment-emergent adverse events
Left ventricular ejection fraction (LVEF)
The difference of LVEF from baseline. LVEF will be assessed by echocardiography.
Left ventricular ejection fraction (LVEF)
The difference of LVEF from baseline. LVEF will be assessed by Cardiac Magnetic Resonance (CMR).
Enhanced volume (volume%)
The difference of Enhanced volume (volume%) from baseline. Enhanced volume will be assessed by CMR.
INTERMACS Profile
Profile 1. Critical cardiogenic shock; Profile 2. Progressive decline on inotropic support; Profile 3. Stable but inotrope dependent; Profile 4. Resting symptoms home on oral therapy; Profile 5. Exertion Intolerant; Profile 6. Exertion Limited; Profile 7. Advanced NYHA Class III symptoms
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