Designer cells aim to calm immune system after massive heart attack
NCT ID NCT07380659
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests a new treatment for people in shock after a severe heart attack. The therapy uses specially engineered immune cells (CAR-DC) to target a protein found in heart scar tissue, aiming to calm the immune response. The study will enroll 18 patients and primarily check for safety and side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- genetically modified immune cells (CAR-DC) targeting a heart scar protein
- What this could lead to
- If it works, this could point toward a new way to reduce inflammation and improve recovery after a severe heart attack.
- What could go wrong
- This is a very early, small safety trial (18 people). The therapy is new and unproven; it may not help or could cause serious side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 18 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A second chance for the heart: can rehab rewrite the story after shock?
- Blood filter may calm the deadly inflammation of cardiogenic shock
- Microscopic blood vessel health may hold key to cardiogenic shock survival
- Can a machine support a failing heart without overworking it?
- Blood markers may sharpen prognosis in cardiogenic shock
- Can an external heart pump keep shock patients alive?