Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Phase 1
Started
2026-01-20
Last updated
2026-02-02
Condition(s) studied
Cardiogenic ShockCardiogenic Shock Post Myocardial InfarctionSTEMI - ST Elevation Myocardial Infarction
Investigational drug(s) / intervention(s)
FAP allogeneic immunosuppressive CAR-DC
FAP allogeneic immunosuppressive CAR-DC: Each subject receive FAP immunosuppressive CAR-DC by intravenous infusion at the first day of shock.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria(patients):
* Age ≥ 18 years and \< 80 years.
* Acute ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock, meeting all the following conditions:
1. Post-emergent revascularization (PCI or CABG)
2. Systolic blood pressure \< 90 mmHg for \>30 minutes, or requiring catecholamine support to maintain systolic blood pressure \>90 mmHg
3. Signs of impaired organ perfusion, meeting at least one of the following criteria:
1. Altered mental status
2. Cold, clammy skin and extremities
3. Oliguria, with urine output \<30 mL/h
4. Arterial lactate level \>2 mmol/L
* The patient or their legally authorized representative is capable of providing verbal confirmation of understanding the trial risks, benefits, and treatment alternatives associated with receiving immunosuppressive CAR-DC therapy, and provides written informed consent prior to participation in this clinical trial.
Exclusion Criteria(patients):
1. Acute mechanical complications of infarction (e.g., ventricular septal rupture, acute mitral regurgitation).
2. Cardiac arrest.
3. Hypoxic-ischemic brain injury (cerebral injury with fixed and dilated pupils not attributable to medication).
4. Shock due to other causes (e.g., sepsis, hypovolemia).
5. Resuscitation duration \>30 minutes.
6. Absence of spontaneous cardiac activity.
7. Persistent electrical instability.
8. Active bleeding or contraindications to heparin use.
9. Active autoimmune disease requiring immunosuppressive therapy.
10. History of malignancy.
11. Infection, including:
* Active hepatitis B (HBV DNA \>1000 copies/mL by PCR), hepatitis C, syphilis, or HIV infection at screening.
* Uncontrolled systemic fungal, bacterial, viral, or other pathogen infections.
12. Pregnant women.
13. Contraindications to the investigational drug or study procedures.
Inclusion Criteria(donors):
* Age ≥ 18 years and ≤ 75 years.
* Has provided written informed consent.
* Hematocrit \>30%, lymphocyte count \>0.5 × 10\^9/L, platelet count \>60 × 10\^9/L.
* Pathogen screening results must be negative for HIV (antigen, core antibody, and RNA), HBV (surface antigen and core antibody), HCV, syphilis, CMV, and EBV.
Exclusion Criteria(donors):
* Active infection requiring treatment.
* History of malignancy.
* Active autoimmune disease requiring immunosuppressive therapy.
Primary outcome measure(s)
The proportion of subjects with Dose-limiting toxicity (DLT) — in 14 days after injection The proportion of participants with DLT as assessed by CTCAE v5.0
Incidence of treatment-emergent adverse events (TEAEs) — in 14 days after injection Incidence of iCDC treatment-emergent adverse events
Trial sites (1)
Facility
City
Region
Status
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou
Zhejiang
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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