Safety and Efficacy of FAP iCDC in Acute Myocardial Infarction With Cardiogenic Shock

NCT07380659 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: YAN2025-1716
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiogenic Shock; STEMI - ST Elevation Myocardial Infarction; Cardiogenic Shock Post Myocardial Infarction

Keywords

acute myocardial infarction with cardiogenic shock

Outcome Measures

Primary Outcomes (2)

• The proportion of subjects with Dose-limiting toxicity (DLT)

  The proportion of participants with DLT as assessed by CTCAE v5.0

  in 14 days after injection

• Incidence of treatment-emergent adverse events (TEAEs)

  Incidence of iCDC treatment-emergent adverse events

  in 14 days after injection

Secondary Outcomes (29)

• All-cause mortality

  30 days after injection

• Systolic blood pressure

  24 hours、48 hours、72 hours、7 days after injection

• Diastolic blood pressure

  24 hours、48 hours、72 hours、7 days after injection

• Mean arterial pressure

  24 hours、48 hours、72 hours、7 days after injection

• Time to hemodynamic stability

  From the end of the iCDC infusion to achievement of hemodynamic stability, assessed continuously until ICU discharge (up to 30 days).

Study Arms (2)

Administration of allogeneic FAP iCDC

EXPERIMENTAL

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

Standard therapy

NO INTERVENTION

Patients in the control group do not receive cellular therapy intervention.

Interventions

FAP allogeneic immunosuppressive CAR-DC BIOLOGICAL

Each subject receive FAP immunosuppressive CAR-DC by intravenous infusion at the first day of shock.

Administration of allogeneic FAP iCDC

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years and \< 80 years.
• Acute ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock, meeting all the following conditions:
• Post-emergent revascularization (PCI or CABG)
• Systolic blood pressure \< 90 mmHg for \>30 minutes, or requiring catecholamine support to maintain systolic blood pressure \>90 mmHg
• Signs of impaired organ perfusion, meeting at least one of the following criteria:
• Altered mental status
• Cold, clammy skin and extremities
• Oliguria, with urine output \<30 mL/h
• 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.

You may not qualify if:

• Acute mechanical complications of infarction (e.g., ventricular septal rupture, acute mitral regurgitation).
• Cardiac arrest.
• Hypoxic-ischemic brain injury (cerebral injury with fixed and dilated pupils not attributable to medication).
• Shock due to other causes (e.g., sepsis, hypovolemia).
• Resuscitation duration \>30 minutes.
• Absence of spontaneous cardiac activity.
• Persistent electrical instability.
• Active bleeding or contraindications to heparin use.
• Active autoimmune disease requiring immunosuppressive therapy.
• History of malignancy.
• 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.
• Pregnant women.
• Contraindications to the investigational drug or study procedures.

Sponsors & Collaborators

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

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Shock, Cardiogenic; ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Xinyang Hu, PhD

  Second Affiliated Hospital, School of Medicine, Zhejiang University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiamin Li, MD

CONTACT

86-18868112006; 21818216@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: February 2, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)