Safety and Efficacy of FAP iCDC in Ischemia Cardiomyopathy

NCT07505199 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: YAN2026-0257
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

To study the safety and efficacy of fibroblast activation protein (FAP)-targeted autologus immunosuppressive chimeric antigen receptor-dendritic cell (CAR-DC) in the treatment of ischemic cardiomyopathy, aiming to provide a novel therapeutic strategy for the disease.

Conditions

Ischemic Cardiomyopathy; Cell Therapy

Keywords

ischemic cardiomyopathy; dendritic cell; immune tolerance

Outcome Measures

Primary Outcomes (2)

• Incidence of Dose-Limiting Toxicities (DLT)

  Incidence of dose-limiting toxicities (DLT) within 14 days after administration of FAP-targeted immunoregulatory CAR-DC therapy

  Within 14 days after treatment

• 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.

  Within 6 months after treatment

Secondary Outcomes (25)

• Change in Left Ventricular Ejection Fraction (LVEF) by Echocardiography

  Baseline, 3 months, 6 months, and 12 months

• Change in Left Ventricular Ejection Fraction as assessed by Cardiac MRI

  Baseline, 6 months, and 12 months

• Change in Myocardial Late Gadolinium Enhancement Volume by CMR

  Baseline, 6 months, and 12 months

• Change in left ventricular end-systolic diameter measured by Echocardiography

  Baseline, 3 months, 6 months, and 12 months

• Change in left ventricular end-diastolic diameter measured by Echocardiography

  Baseline, 3 months, 6 months, and 12 months

Study Arms (1)

Administration of autologus FAP iCDC

EXPERIMENTAL

Administration of FAP immunosuppressive CAR-DC cell therapy in ischemic cardiomyopathy. Patients are planned to be enrolled in the dose-escalation trial (1×10\^5/kg、4×10\^5/kg、and 8×10\^5/kg) .The first dose group (4×10⁵/kg) initially enrolls 3 subjects to observe Dose-Limiting Toxicity (DLT) responses. （1）If no DLT occurs and all 3 subjects demonstrate efficacy after 6 months of treatment, and this dose is determined as the safe and effective dose. （2）If 1 subject experiences DLT, 3 additional subjects are enrolled. ·If 1/6 subjects develops DLT, and efficacy is not fully achieved in all 6 subjects, escalate to the next dose group (8×10\^5/kg). ·If ≥2/6 subjects develop DLT, de-escalate to the previous dose group (1×10\^5/kg). （3）After identifying a safe and effective dose, enrollment will be expanded at this dose to bring the total sample size to 15 subjects, to further evaluate safety and efficacy.

Biological: autologus FAP-targeted immunosuppressive CAR-DCs (iCDC)

Interventions

autologus FAP-targeted immunosuppressive CAR-DCs (iCDC) BIOLOGICAL

Each subject receives FAP-targeted immunosuppressive CAR-DCs by intravenous infusion after enrollment.

Administration of autologus FAP iCDC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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 \<15 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Central Study Contacts

Jiamin Li, MD

CONTACT

86-18868112006; 21818216@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 1, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share