A Phase 1 interventional study of FAP allogeneic immunosuppressive CAR-DC in Cardiogenic Shock, Cardiogenic Shock Post Myocardial Infarction and STEMI - ST Elevation Myocardial Infarction, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-02.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Phase 1, Interventional, and Treatment
To study the safety and efficacy of fibroblast activation protein (FAP)-targeted allogeneic immunosuppressive chimeric antigen receptor-dendritic cell (CAR-DC) in the treatment of acute myocardial infarction with cardiogenic shock and provide a new method for the treatment of acute myocardial infarction with cardiogenic shock.
Background: Cardiogenic shock following acute myocardial infarction (AMI) remains a major unresolved clinical challenge. Despite advances in urgent revascularization and mechanical circulatory support, short-term mortality remains unacceptably high, approaching 40% within 30 days. Few evidence-based therapies have demonstrated a meaningful survival benefit, highlighting the urgent need for novel, mechanism-driven interventions. Growing clinical and experimental evidence indicates that a dysregulated systemic inflammatory response-manifested by hyperthermia, leukocytosis, and elevated proinflammatory mediators-plays a central role in the pathophysiology and progression of cardiogenic shock. Excessive inflammation exacerbates myocardial dysfunction, promotes multiorgan injury, and impairs recovery, suggesting that targeted immunomodulation may represent a complementary therapeutic strategy in this high-risk population. Dendritic cells (DCs), as professional antigen-presenting cells, occupy a pivotal position at the interface of innate and adaptive immunity and are uniquely suited to orchestrate context-dependent immune responses. In particular, tolerogenic DCs exert potent immunosuppressive effects through regulatory cytokine production, expression of co-inhibitory ligands, antigen-specific suppression of effector T cells, and induction of regulatory T cells. Collectively, these properties render DCs an attractive yet underexplored cellular platform for resolving excessive inflammation and promoting tissue repair in cardiogenic shock with AMI.
Purpose: In this prospective clinical study, the investigators engineered a stable, immunosuppressive, and fibrotic lesion-targeted DC therapy, termed immunosuppressive DCs (iCDC). This study was designed to evaluate the safety and preliminary efficacy of allogeneic fibroblast activation protein (FAP)-targeted iCDC therapy in patients with AMI complicated by cardiogenic shock.
Study design: This single-center, prospective, concurrent non-randomized controlled clinical trial enrolls patients aged 18-80 years presenting with acute myocardial infarction complicated by cardiogenic shock. Eligible patients are treated with allogeneic FAP-targeted immunosuppressive iCDC therapy.
Outcome measure: The primary outcome is the safety of FAP-targeted immunosuppressive iCDC therapy in patients with AMI complicated by cardiogenic shock. Secondary outcomes include 30-day all-cause mortality; hemodynamic parameters following iCDC therapy (systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate); time to hemodynamic stabilization; dose and duration of vasopressor and inotropic support; arterial lactate levels; changes in biomarkers (BNP, CRP, creatinine, ALT, AST, and inflammatory mediators); need for and duration of mechanical ventilation; need for and duration of left ventricular assist device implantation; intensive care unit and total hospital length of stay; left ventricular ejection fraction assessed by echocardiography; SAPS II score; SCAI shock classification; heart failure symptom burden assessed by NYHA functional class and the Kansas City Cardiomyopathy Questionnaire; incidence of major adverse cardiovascular events (MACE), including cardiac death and heart failure hospitalization; and incidence of adverse events.
277 studies on the registry are indexed under Shock, Cardiogenic; 127 are open to participants now.
This study's planned enrollment of 18 is below the median of 80 across 127 interventional studies indexed under Shock, Cardiogenic.
Browse Shock, Cardiogenic studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,058 studies on the registry; 511 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria（patients）:
Acute ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock, meeting all the following conditions:
Signs of impaired organ perfusion, meeting at least one of the following criteria:
Exclusion Criteria（patients）:
Infection, including:
Inclusion Criteria（donors）:
Exclusion Criteria（donors）:
Administration of FAP immunosuppressive CAR-DC cell therapy in AMI CS. 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 8-10 subjects, to further evaluate safety and efficacy.
Biological: FAP allogeneic immunosuppressive CAR-DC
Patients in the control group do not receive cellular therapy intervention.
Each subject receive FAP immunosuppressive CAR-DC by intravenous infusion at the first day of shock.
The proportion of subjects with Dose-limiting toxicity (DLT)
The proportion of participants with DLT as assessed by CTCAE v5.0
Time frame: in 14 days after injection
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of iCDC treatment-emergent adverse events
Time frame: in 14 days after injection
All-cause mortality
All-cause mortality at 30 days after iCDC treatment
Time frame: 30 days after injection
Systolic blood pressure
Systolic blood pressure (mmHg) measured using a calibrated sphygmomanometer under standardized conditions.
Time frame: 24 hours、48 hours、72 hours、7 days after injection
Diastolic blood pressure
Diastolic blood pressure (mmHg) measured using a calibrated sphygmomanometer under standardized conditions.
Time frame: 24 hours、48 hours、72 hours、7 days after injection
Mean arterial pressure
The mean arterial pressure (MAP) is calculated using the following formula: MAP=DBP+1/3(SBP-DBP)；DBP : Diastolic blood pressure，SBP ：Systolic blood pressure
Time frame: 24 hours、48 hours、72 hours、7 days after injection
Time to hemodynamic stability
Sustained (\> 60 min) systolic blood pressure \>90 mmHg without requirement for catecholamines and without signs of peripheral endorgan hypoperfusion
Time frame: From the end of the iCDC infusion to achievement of hemodynamic stability, assessed continuously until ICU discharge (up to 30 days).
Dose of vasopressors
Dose of vasopressors administered to the participant.
Time frame: 24 hours、48 hours、72 hours、7 days after injection
Duration of vasopressor use
Duration of vasopressor therapy in days treated with vasopressor between enrollment and hospital discharge. A day treated with vasopressor is any day during the hospital period where the patient received a vasopressor.
Time frame: From enrollment to hospital discharge (up to 30 days).
Dose of inotropic drugs
Dose of inotropic drugs administered to the participant.
Time frame: 24 hours、48 hours、72 hours、7 days after injection
Duration of inotropic drugs use
Duration of inotropic drugs therapy in days treated with inotropic drugs between enrollment and hospital discharge. A day treated with inotropic drugs is any day during the hospital period where the patient received inotropic drugs
Time frame: From enrollment to hospital discharge (up to 30 days).
Serum lactate level
Lactate is assessed via arterial blood gas analysis.
Time frame: The measurement frequency is once every 8 hours for a duration of 48 hours.
Change in B-type natriuretic peptide (BNP) level from baseline
Change in serum B-type natriuretic peptide concentration compared with baseline.
Time frame: 7 days，14 days，30 days after injection.
Change in C-reactive protein (CRP) level from baseline
Change in serum C-reactive protein concentration compared with baseline.
Time frame: 24 hours, 72 hours, 7 days，14 days after injection.
Change in serum creatinine level from baseline
Change in serum creatinine concentration compared with baseline.
Time frame: 24 hours, 72 hours, 7 days，14 days after injection.
Change in ALT (Alanine Aminotransferase) level from baseline
Change in serum ALT concentration compared with baseline.
Time frame: 24 hours, 72 hours, 7 days，14 days after injection.
Change in AST (Aspartate Aminotransferase) level from baseline
Change in serum AST concentration compared with baseline.
Time frame: 24 hours, 72 hours, 7 days，14 days after injection.
Change in Interleukin-6 (IL-6) levels from baseline
Change in serum Interleukin-6 (IL-6) levels compared with baseline.
Time frame: 24 hours, 72 hours, 7 days，14 days after injection.
Need for mechanical ventilation
Need for mechanical ventilation is defined as requiring invasive or non-invasive positive pressure ventilation for at least 1 hour due to respiratory failure.
Time frame: From the end of the drug infusion until ICU discharge (up to 30 days).
Duration of mechanical ventilation
Duration of mechanical ventilation is defined as the total number of hours from the initiation of invasive or non-invasive ventilation until the last successful extubation
Time frame: From the initiation of mechanical ventilation until ICU discharge (up to 30 days).
Requirement for left ventricular assist device implantation
Requirement for left ventricular assist device implantation is defined as the need for implantation of a left ventricular assist device as bridge-to-transplant or destination therapy in patients with cardiogenic shock or end-stage heart failure who fail to maintain adequate end-organ perfusion despite optimized medical therapy.
Time frame: From the end of iCDC infusion through study completion (up to 30 days).
Duration of left ventricular assist device use
Duration of left ventricular assist device use is defined as the total time from completion of device implantation until device removal, patient death, or the study cutoff date, whichever occurs first.
Time frame: From left ventricular assist device implantation through study completion (up to 30 days).
Simplified Acute Physiology Score II
The Simplified Acute Physiology Score II (SAPS II) is a validated severity-of-disease scoring system used to assess the physiological status of critically ill patients. The score ranges from 0 to 163, with higher scores indicating greater disease severity and a worse prognosis. SAPS II will be calculated based on the worst physiological values recorded during each 24-hour period.
Time frame: Daily from ICU admission through ICU discharge (up to 30 days).
time to recovery from cardiogenic shock
Time to recovery from cardiogenic shock is defined as the duration from the end of the single study drug infusion to the achievement of predefined criteria for hemodynamic stability and improvement in end-organ perfusion.
Time frame: From the end of iCDC infusion to recovery from cardiogenic shock, assessed continuously until ICU discharge (up to 30 days).
length of stay at the intensive care unit
Length of stay in the ICU is defined as the total time from ICU admission until ICU discharge.
Time frame: From ICU admission until ICU discharge (up to 30 days).
Length of hospital stay;
Total hospital length of stay is defined as the total calendar days from patient admission registration until final discharge or death, whichever occurs first.
Time frame: From hospital admission until hospital discharge or death (up to 30 days).
Left ventricular ejection fraction (LVEF)
The difference of LVEF from baseline. LVEF will be assessed by echo.
Time frame: 1 month after injection
SCAI Shock Classification
The SCAI shock classification is a standardized, five-stage system (from A to E) used to categorize the severity of cardiogenic shock based on clinical, hemodynamic, and biomarker criteria.
Time frame: 3 days、7 days、14 days after injection
assessment of heart failure symptom
The difference of heart failure symptom, which will be assessed by NYHA grading and KCCQ score.
Time frame: 1 month after injection
Incidence of major adverse cardiovascular events (MACE)
Incidence of Cardiac death, readmission due to heart failure.
Time frame: 1 month after injection
incidence of adverse events
Incidence of adverse events of heart, nerve system, mental system, digestive system and immune system.
Time frame: From the end of the drug infusion through study completion，up to 30 days.
Plan to share: No
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Second Affiliated Hospital, School of Medicine, Zhejiang University