Personalized immune cell therapy aims to clear stubborn COVID-19 infections
NCT ID NCT07690943
First seen Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time
Summary
This study tests a treatment called LB-DTK-COV19, made from a patient's own immune cells, for people who have had COVID-19 symptoms or a positive test for more than 21 days. Participants receive two infusions of their personalized T cells, two weeks apart, and are followed for six months. The goal is to see if the treatment is safe, reduces viral levels, and improves symptoms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LB-DTK-COV19 (a personalized T cell therapy made from the patient's own immune cells)
- What this could lead to
- If it works, this could offer a treatment for people with long COVID who still carry the virus, potentially clearing the infection and relieving symptoms.
- What could go wrong
- This is a very small early-stage trial with only 13 participants, so results may not apply broadly. The therapy is complex and may cause side effects or fail to reduce viral levels.
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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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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13 people
The number who actually took part.
- Started
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Jun 2023
- Finished
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Jan 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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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19 years and older
- 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: 1. Patients aged 19 years or older. 2. Patients who tested positive for COVID-19 RT-PCR with persistent COVID-19 symptoms and experienced initial symptoms or received a first COVID-19 diagnosis more than 21 days prior to treatment. * Given that LB-DTK-COV19 requires 21 days to manufacture, patients who experienced initial symptoms or received a first COVID-19 diagnosis more than 7 days prior to screening may be eligible for enrollment. Following registration, COVID-19 RT-PCR positivity will be reassessed 21 days later. Eligible patients with confirmed positive COVID-19 test results will receive the study product infusion. Patients who test negative for COVID-19 will be withdrawn from the study. 3. Patients who fulfill Inclusion Criteria 2) and are moderately immunocompromised. 4. Patients who fulfill Inclusion Criteria 2) and are refractory to standard of care (including steroids, immunosuppressants, etc depending on the severity of the disease). 5. Patients with a life expectancy longer than 3 months. 6. Patients who have voluntarily decided to participate in this clinical study and have provided written consent to comply with the restrictions. Exclusion Criteria: 1. Critically ill patients (WHO ordinal scale, category 7 or higher) who meet any of the following criteria: * Require invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) * Diagnosed with acute respiratory distress syndrome (ARDS), shock, or multiple organ failure. 2. Patients with lung diseases other than COVID-19 pneumonia (including chronic obstructive pulmonary disease, asthma, cystic lung disease, tuberculosis, etc) 3. Female subjects who are pregnant, breastfeeding, of childbearing potential, or not using appropriate contraceptive methods. 4. Patients with active infection or fever (≥38°C) of unknown etiology, or ongoing bacterial or fungal infection. 5. Patients aged less than 19 years. 6. Patients who have been diagnosed with HIV, uncontrollable hypertension, unstable angina, congestive heart failure (NY class II or higher), uncontrollable severe diabetes, coronary angioplasty within the past 6 months, acute myocardial infarction or non-malignant disease, including uncontrollable atrial or ventricular fibrillation, within the past 6 months. * Uncontrollable hypertension is defined as Systolic BP ≥160 mmHg or Diastolic BP ≥100 mmHg despite taking blood pressure medications. * Severe diabetes is defined as follows: * Severe hyperglycemia with HbA1c ≥ 10.0% * Individuals who have been hospitalized for diabetic ketoacidosis within the past 12 weeks * Individuals who have received emergency treatment or been hospitalized within the past 12 weeks for severe hypoglycemia (glucose \< 54mg/dL) accompanied by seizures and loss of consciousness 7. Patients with mental illness or drug intoxication that may affect the results of this clinical study. 8. Patients who are participating in another clinical study. 9. Patients deemed ineligible for participation in this clinical study by the investigator. 10. Patients with other severe medical conditions that may compromise compliance with the clinical study.
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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.
Contacts and locations
Locations
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The Catholic University of Korea Seoul St.Mary's Hospital
Seoul, 06591, South Korea
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