Donor t cells aim to fight severe COVID-19
NCT ID NCT07709637
First seen Jul 16, 2026 · Last updated Aug 27, 2026 · Updated 5 times
Summary
This early-stage trial tests a therapy made from donor immune cells, called LB-DTK-COV19, in adults with severe COVID-19. The cells are designed to target the virus and are given as a single infusion. The study aims to find a safe dose and see if the treatment can improve symptoms and reduce viral levels.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- allogeneic SARS-CoV-2-specific T cells (LB-DTK-COV19)
- What this could lead to
- If successful, this approach could offer a new treatment option for severe COVID-19 by boosting the immune system's ability to fight the virus.
- What could go wrong
- This is a very early, small Phase 1 trial with only one participant, so results may not be generalizable. Safety and effectiveness are still unknown.
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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1 person
The number who actually took part.
- Started
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Jul 2025
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- 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. Adults aged 19 years or older at the time of screening (Visit 1). 2. Individuals confirmed positive for COVID-19 by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) testing. If the test was conducted more than 10 days prior to the screening date, retesting is required for enrollment. The testing criteria follow the "Guidelines for Laboratory Diagnosis of COVID-19". 3. Individuals who have received treatment with two or more antiviral drugs. 4. Patients who are refractory to standard-of-care. 5. Individuals who meet all the following criteria of persistent COVID-19: * Viral Criteria: Positive COVID-19 PCR test results persisting for more than 14 days after the initial positive test * Clinical Criteria: Individuals with two or more of the following symptoms for 14 days or more either intermittently or continuously * Fever * Fatigue * Respiratory symptoms * Weight loss * Diarrhea * Increase in inflammatory markers * Imaging Criteria: Clinically significant change in lung parenchyma based on chest CT. * Medical History Criteria: Individuals who meet any of the following criteria * Administered CD20 inhibitor in the past 1 year * Hematologic malignancies (ex. CLL, MM, NHL, etc) * Undergone hematopoietic stem cell transplantation or GVHD treatment in the past 1 year * Undergone CAR-T therapy * Solid organ transplant patients * Primary hypogammaglobulinemia * Other severe primary or acquired immunodeficiency 6. Female participants or male participants with female partners who agree to maintain the following contraception methods during the clinical trial period, and who meet one of the following criteria: * The female participant or the female partner of the male participant is postmenopausal (defined as non-therapy-induced amenorrhea for 12 months or more, or as medically confirmed menopause) * The female participant or the female partner of the male participant is infertile due to surgical sterilization (ex. removal of ovaries and/or uterus) * Agrees to absolute abstinence during the clinical trial period \[For female participants, intermittent abstinence (ex. ovulation timing, symptom-based temperature monitoring, or withdrawal methods) is not considered as agreeing to abstinence\] * If the female participant or the female partner of the male participant is a woman of childbearing potential (WOCBP) who has not undergone sterilization surgery, one of the following contraception methods must be used: * Hormonal methods (implant, patch, oral contraceptives) * Intrauterine device * Dual barrier methods (simultaneous use of two methods, such as male condoms, female condoms, cervical caps, diaphragms, or contraceptive sponges) 7. For women of childbearing potential or women who are less than 12 months postmenopausal, a negative pregnancy test (blood test) confirmed at the screening visit. 8. Individuals who have at least one HLA match with the investigational drug in MHC class I. 9. Individuals who voluntarily agree to participate in this clinical trial and provide written consent to comply with the restrictions. 10. Individuals deemed suitable as study subjects through screening tests (vital signs, physical examination, medical and surgical history, electrocardiogram, laboratory tests, etc). Exclusion Criteria: 1. Severely ill patients who meet the following criteria: * Requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) * Acute respiratory distress syndrome (ARDS), shock, or multiple organ failure 2. Uncontrolled pulmonary diseases other than COVID-19 pneumonia (ex. chronic obstructive pulmonary disease, asthma, cystic fibrosis, tuberculosis, etc.) 3. Patients requiring intubation, mechanical ventilation (WHO 8-OS stage 6), or ECMO (stage 7) at the time of screening. 4. Individuals who have received treatment with ATG (Antithymocyte Globulin), Campath, or other T-cell immunosuppressive monoclonal antibodies within 28 days prior to the screening visit. 5. Patients with uncontrollable hypertension, uncontrollable diabetes, other viral infections (ex. Human immunodeficiency virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV), etc), syphilis, refractory malignancy, moderate or severe liver damage \[Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \> 5 Lab normal range (LNR)\], or chronic kidney diseases (estimated Glomerular filtration rate (eGFR) \< 30 mL/min/1.73m\^2) based on medical history or at the time of screening. * Uncontrollable hypertension is defined as Systolic BP ≥160mmHg or Diastolic BP ≥100 mmHg despite taking blood pressure medications (Up to 3 measurements with a minimum interval of 5 minutes) * Severe diabetes is defined as follows: 1. Severe hyperglycemia with HbA1c ≥ 10.0% 2. Individuals who have been hospitalized for diabetic ketoacidosis within the past 12 weeks 3. 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 6. Patients with a history of substance abuse within 6 months prior to the administration of the investigational product, or those suspected of taking drugs prone to misuse based on medical interviews and physical examinations. 7. Patients who require vasopressors. 8. Patients with a history of hypersensitivity to T-cell therapy. 9. Patients with a history of autoimmune diseases. 10. Patients with hemophilia or receiving anticoagulant therapy who are at significant risk of bleeding during injection. 11. Patients who participated in another clinical study within 24 weeks prior to the administration of the investigational product. 12. Patients with a life expectancy of less than 24 hours at the time of screening. 13. Other patients deemed unsuitable for participation in this clinical trial by the investigator.
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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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Other studies related to the condition(s) this trial covers.
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