Safety and Efficacy of FAP iCDC in Ischemic Cardiomyopathy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
About this trial
This study aims to evaluate the safety and efficacy of fibroblast activation protein (FAP)-targeted autologous immunosuppressive chimeric antigen receptor dendritic cell (iCDC) therapy in patients with ischemic cardiomyopathy, and to explore its potential as a novel therapeutic strategy for this disease.
Eligibility criteria
Qualifiers
Age ≥18 years and ≤75 years.
Diagnosis of ischemic cardiomyopathy, with at least 3 months of optimized guideline-directed medical therapy (GDMT) at maximally tolerated doses; left ventricular ejection fraction (LVEF) <35%; New York Heart Association (NYHA) functional class III-IV.
Ability to understand the risks, benefits, and treatment alternatives of immunoregulatory CAR-DC therapy, and willingness to participate in the study; the patient or his/her legally authorized representative must provide written informed consent prior to study enrollment.
Adequate hematologic function defined as: hematocrit >30%, lymphocyte count >0.5 × 10⁹/L, and platelet count >60 × 10⁹/L.
Disqualifiers
Life expectancy <1 year due to non-cardiac conditions.
Trial design
Treatments tested in this trial
- autologus FAP-targeted immunosuppressive CAR-DCs (iCDC)
- Standard medical treatment
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov