Donor t cells aim to fight severe COVID-19

NCT ID NCT07709637

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

1 person

The number who actually took part.

Started

Jul 2025

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

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

19 years and older

Sex

Anyone

Healthy volunteers

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

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

  • 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.