NCT07505199 Safety and Efficacy of FAP iCDC in Ischemic Cardiomyopathy
| NCT ID | NCT07505199 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine |
| Condition | Ischemic Cardiomyopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-05-21 |
| Primary Completion | 2028-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2026-05-21 with a primary completion date of 2028-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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. Exclusion Criteria: * Life expectancy \<1 year due to non-cardiac conditions. Cardiac resynchronization therapy (CRT) implantation within 3 months prior to enrollment or planned CRT implantation. Percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 3 months prior to enrollment OR plan to PCI. Presence of non-ischemic cardiomyopathy, including but not limited to dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy, arrhythmogenic cardiomyopathy, peripartum cardiomyopathy, inflammatory or immune-mediated cardiomyopathy, metabolic or genetic cardiomyopathy, or cardiomyopathy secondary to moderate-to-severe valvular heart disease, congenital heart disease, or other non-ischemic etiologies. Persistent hemodynamic instability. End-stage renal disease (eGFR \<25 mL/min/1.73 m²) requiring or receiving renal replacement therapy (hemodialysis or peritoneal dialysis). Active autoimmune disease requiring immunosuppressive therapy. History of malignancy. Active infection, including but not limited to active hepatitis B (HBV DNA \>1000 copies/mL by PCR), hepatitis C, syphilis, or human immunodeficiency virus (HIV) infection, or uncontrolled systemic fungal, bacterial, viral, or other infections. Pregnant women. Known contraindications to the investigational product or study-related procedures.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07505199 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Ischemic Cardiomyopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07505199 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07505199 currently recruiting?
Yes, NCT07505199 is actively recruiting participants. Contact the research team at 21818216@zju.edu.cn for enrollment information.
Where is the NCT07505199 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07505199 clinical trial?
NCT07505199 is sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. The trial plans to enroll 30 participants.