Dilated Cardiomyopathy (DCM)Phase 1NCT07516288
Safety and Efficacy of Second Infusion of FAP iCDC in End-stage Dilated Cardiomyopathy
A Phase 1 study testing FAP immunosuppressive CAR-DC in people with Dilated Cardiomyopathy (DCM) and Heart Failure, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
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 more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dilated Cardiomyopathy (DCM), Heart Failure
- What is being tested?
- FAP immunosuppressive CAR-DC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 11 May 2026to 31 Dec 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
Who cannot join
- 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.
- 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 hemodynamic instability (e.g., shock).
- Known contraindications to the investigational product or study-related procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang / 浙江, 310009
Jiamin Li, Dr, 18868112006, 21818216@zju.edu.cn
21818216@zju.edu.cn
About this study
Official title: 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.
Read the detailed description
Heart failure is a life-threatening syndrome with high morbidity and mortality. Dilated cardiomyopathy (DCM) is a major cause of end-stage heart failure, and currently available treatments for advanced DCM remain limited.
Immune activation and myocardial fibrosis play key roles in the progression of heart failure. Targeting cardiac fibrosis through immune modulation has emerged as a potential therapeutic strategy. Our research group has developed a novel immunosuppressive chimeric antigen receptor-modified dendritic cell (CAR-DC) therapy targeting fibroblast activation protein (FAP), designed to reduce cardiac fibrosis and improve cardiac function.
Preclinical studies demonstrated that FAP-targeted immunosuppressive CAR-DC (iCDC) therapy significantly improved cardiac function and survival in animal models of heart failure, with a favorable safety profile. Based on these findings, an exploratory clinical study of single-dose iCDC infusion in patients with end-stage DCM has been conducted, and preliminary follow-up results up to three months have shown good safety and potential clinical benefit.
However, in clinical practice, patients with end-stage DCM may experience recurrent deterioration of cardiac function due to infections or other triggers. Whether a second administration of iCDC can restore or further improve cardiac function remains unknown.
Therefore, this study aims to evaluate the safety and preliminary efficacy of a second infusion of FAP-targeted immunosuppressive CAR-DC in patients with end-stage dilated cardiomyopathy who experience worsening heart function after initial treatment.
- Conditions
- Dilated Cardiomyopathy (DCM), Heart Failure
- Being tested
- FAP immunosuppressive CAR-DC
- Keywords
- end-stage dilated cardiomyopathy, FAP immunosuppressive CAR-DC
- Medical subject headings
- Cardiomyopathy, Dilated, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAP immunosuppressive CAR-DCBiological
Each subject receive FAP immunosuppressive CAR-DC by intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| dilated cardiomyopathy | Experimental | All participants will receive a second infusion of CAR-DC at the predetermined safe and effective dose of 4×10⁵ cells/kg, administered intravenously. Receives: Biological: FAP immunosuppressive CAR-DC |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects with Dose-limiting toxicity (DLT)
The proportion of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: in 14 days after injection
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of iCDC treatment-emergent adverse events
Measured: in 14 days after injection
Secondary outcomes (14)
Left ventricular ejection fraction (LVEF)
The difference of LVEF from baseline. LVEF will be assessed by echocardiography.
Measured: 1, 3, 6 months after injection
Left ventricular ejection fraction (LVEF)
The difference of LVEF from baseline. LVEF will be assessed by Cardiac Magnetic Resonance (CMR).
Measured: 6 months after injection
Enhanced volume (volume%)
The difference of Enhanced volume (volume%) from baseline. Enhanced volume will be assessed by CMR.
Measured: 6 months after injection
INTERMACS Profile
Profile 1. Critical cardiogenic shock; Profile 2. Progressive decline on inotropic support; Profile 3. Stable but inotrope dependent; Profile 4. Resting symptoms home on oral therapy; Profile 5. Exertion Intolerant; Profile 6. Exertion Limited; Profile 7. Advanced NYHA Class III symptoms
Measured: 1, 3, 6 months after injection
Left ventricular internal diameter end systole (LVIDs)
The difference of LVIDs from baseline. LVIDs will be assessed by echocardiography.
Measured: 1, 3, 6 months after injection
Left ventricular internal diameter end diastole (LVIDd)
The difference of LVIDd from baseline. LVIDd will be assessed by echocardiography.
Measured: 1, 3, 6 months after injection
Left ventricular end-systolic volume (LVESV)
The difference of LVESV from baseline. LVESV will be assessed by CMR.
Measured: 6 months after injection
Left ventricular end-diastolic volume (LVEDV)
The difference of LVEDV from baseline. LVEDV will be assessed by CMR.
Measured: 6 months after injection
NT-proBNP
Analysis of differences of NT-proBNP serum level from baseline.
Measured: 1, 3, 6 months after injection
6 minutes walk test (6MWT)
The difference of 6MWT from baseline.
Measured: 1, 3, 6 months after injection
Change in New York Heart Association (NYHA) Functional Classification
Assessment of heart failure symptom severity using the New York Heart Association (NYHA) functional classification. NYHA class ranges from I to IV, with higher classes indicating worse functional status.
Measured: Baseline, 1 month, 3 months, and 6 months
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Score
Assessment of heart failure-related health status using the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ score ranges from 0 to 100, with higher scores indicating better health status and quality of life.
Measured: Baseline, 1 month, 3 months, and 6 months
Incidence of major adverse cardiovascular events (MACE)
Incidence of Cardiac death, readmission due to heart failure.
Measured: 1, 3, 6 months after injection
incidence of adverse events
Incidence of adverse events of heart, nerve system, mental system, digestive system and immune system.
Measured: 6 months after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start11 May 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dilated Cardiomyopathy (DCM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xinyang Hu, PhD, Principal investigator, Second Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516288
- Sponsor's protocol ID
- YAN2026-0117
- Status last verified
- Feb 2026
- First submitted
- 24 Mar 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No