Second infusion of engineered immune cells for end-stage dilated cardiomyopathy
Tests a second dose of FAP-targeted CAR-DC cells in end-stage dilated cardiomyopathy.
Plain-language title generated from the registry record
Registry title: Safety and Efficacy of Second Infusion of FAP iCDC in End-stage Dilated Cardiomyopathy
Key facts
- Where
- Hangzhou, ChinaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07516288, who can take part
Where in China
- Second Affiliated Hospital, School of Medicine, Zhejiang UniversityHangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Trial code
- NCT07516288
- Record updated
- 2 July 2026
- Original description
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.Read full original descriptionShow less
Safety and Efficacy of Second Infusion of Autologous Immunosuppressive CAR-DC Targeting FAP in the Treatment of End-stage Dilated Cardiomyopathy
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.
Inclusion: ≥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.
Exclusion: Known contraindications to the investigational product or study-related procedures; 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 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; Severe hemodynamic instability (e.g., shock).