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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
autologus FAP-targeted immunosuppressive CAR-DCs (iCDC)
Biological/VaccineEach subject receives FAP-targeted immunosuppressive CAR-DCs by intravenous infusion after enrollment.
Standard medical treatment
Other interventionParticipants receive standard medical treatment for ischemic cardiomyopathy according to current clinical practice and guideline-directed medical therapy. No iCDC therapy is administered in this arm.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Administration of autologus FAP iCDCExperimental treatment 1 intervention
Group B: Standard treatment controlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Dose-Limiting Toxicities (DLT)
Incidence of dose-limiting toxicities (DLT) within 14 days after administration of FAP-targeted immunoregulatory CAR-DC therapy
Time frame
Within 14 days after treatment2
Incidence of Treatment-Emergent Adverse Events (TEAE)
Incidence of treatment-emergent adverse events (TEAE) occurring within 6 months after treatment in patients with ischemic cardiomyopathy.
Time frame
Within 6 months after treatmentSecondary outcomes
1
Change in Left Ventricular Ejection Fraction (LVEF) by Echocardiography
Change from baseline in left ventricular ejection fraction (LVEF) measured by echocardiography, and between-group difference between the iCDC treatment group and the standard treatment control group.
Time frame
Baseline, 3 months, 6 months2
Change in left ventricular end-systolic volume (LVESV) as assessed by Echocardiography
Change from baseline in left ventricular end-systolic volume (LVESV)measured by echocardiography, and between-group difference between the iCDC treatment group and the standard treatment control group.
Time frame
Baseline, 3 months, and 6 months3
Change in left ventricular end-diastolic volume (LVEDV) by Echocardiography
Change from baseline in left ventricular end-diastolic volume (LVEDV) measured by echocardiography, and between-group difference between the iCDC treatment group and the standard treatment control group.
Time frame
Baseline, 3 months, and 6 months4
Change in global longitudinal strain (GLS) measured by Echocardiography
Change from baseline in global longitudinal strain (GLS) measured by echocardiography, and between-group difference between the iCDC treatment group and the standard treatment control group.
Time frame
Baseline, 3 months, 6 monthsSponsors and contacts
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Source ClinicalTrials.gov