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COVID-19Phase 1NCT07709637

Evaluation of Safety, Tolerance, and Efficacy of Allogeneic LB-DTK-COV19 in Severe Coronavirus Disease 2019 Patients

A Phase 1 study testing LB-DTK-COV19 in people with COVID-19 and COVID-19 (SARS-CoV-2 Infection), run by LucasBio at 1 site in South Korea.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of allogeneic SARS-CoV-2-Specific T cells (LB-DTK-COV19) in patients with persistent clinical symptoms following a positive SARS-CoV-2 PCR test for 14 days or longer. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
COVID-19, COVID-19 (SARS-CoV-2 Infection)
What is being tested?
LB-DTK-COV19
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteSouth Korea
Study dates
31 Jul 2025to 31 Oct 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults aged 19 years or older at the time of screening (Visit 1).
  • 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".
  • Individuals who have received treatment with two or more antiviral drugs.
  • Patients who are refractory to standard-of-care.
  • 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
Show all 34Show fewer
  • 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
  • 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)
  • 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.
  • Individuals who have at least one HLA match with the investigational drug in MHC class I.
  • Individuals who voluntarily agree to participate in this clinical trial and provide written consent to comply with the restrictions.
  • Individuals deemed suitable as study subjects through screening tests (vital signs, physical examination, medical and surgical history, electrocardiogram, laboratory tests, etc).

Who cannot join

  • 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
  • Uncontrolled pulmonary diseases other than COVID-19 pneumonia (ex. chronic obstructive pulmonary disease, asthma, cystic fibrosis, tuberculosis, etc.)
  • Patients requiring intubation, mechanical ventilation (WHO 8-OS stage 6), or ECMO (stage 7) at the time of screening.
  • 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.
Show all 20Show fewer
  • 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:
  • 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
  • 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.
  • Patients who require vasopressors.
  • Patients with a history of hypersensitivity to T-cell therapy.
  • Patients with a history of autoimmune diseases.
  • Patients with hemophilia or receiving anticoagulant therapy who are at significant risk of bleeding during injection.
  • Patients who participated in another clinical study within 24 weeks prior to the administration of the investigational product.
  • Patients with a life expectancy of less than 24 hours at the time of screening.
  • Other patients deemed unsuitable for participation in this clinical trial by the investigator.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • The Catholic University of Korea Seoul St.Mary's Hospital

    Seoul, 06591

Other trials in South Korea

About this study

Official title: A Single Center, Open-Label, Phase I Study to Evaluate the Safety, Tolerance, and Efficacy of Allogeneic LB-DTK-COV19 Cells in Severe Coronavirus Disease 2019 Patients

The goal of this clinical trial is to evaluate the safety, tolerability, and efficacy of allogeneic SARS-CoV-2-Specific T cells (LB-DTK-COV19) in patients with persistent clinical symptoms following a positive SARS-CoV-2 PCR test for 14 days or longer. The main questions it aims to answer are:

  • What is the maximum tolerated dose of LB-DTK-COV19 based on dose-limiting toxicity?
  • What treatment emergent adverse events occur following LB-DTK-COV19 infusion?
  • Does LB-DTK-COV19 result in clinically significant improvement or worsening of clinical symptoms following infusion?
Read more

Participants will:

  • Receive a single intravenous infusion of LB-DTK-COV19 (low dose: 5x10^6/m^2; mid dose:1x10^7/m^2; high dose: 2x10^7/m^2).
  • Attend follow-up visits at the clinic for 6 months after the infusion.
Being tested
LB-DTK-COV19
Keywords
SARS-CoV-2 Infection, Infections, Virus Diseases, Respiratory Symptoms, Hematopoietic Stem Cell Transplantation, Immunocompromised host, Pneumonia, Hematologic Malignancies
Medical subject headings
COVID-19, Infections, Virus Diseases, Signs and Symptoms, Respiratory, Pneumonia, Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LB-DTK-COV19Biological

    LB-DTK-COV19 is an allogeneic SARS-CoV-2-specific T cell therapy product derived from third-party donors and is stored frozen in a colorless, transparent freeze-dried vial until thawed into liquid before administration.

Study groups in NCT07709637
Study groupRoleWhat they receive
LB-DTK-COV19ExperimentalNot described
Receives: Biological: LB-DTK-COV19

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. NCI-CTCAE v5.0 ≥ Grade 3 Rate

    The incidence rate of Grade 3 or higher adverse events, as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), is assessed to evaluate the safety of LB-DTK-COV19. Grade 3-5 adverse events include severe or medically significant, life-threatening, and fatal adverse events.

    Measured: From baseline visit through 24 weeks after treatment initiation.

  2. Adverse Events

    The investigator must confirm the occurrence of adverse events through medical examinations, including interviews and medical history reviews, during regular visits throughout the clinical trial period. Adverse events shall be assessed at each visit starting from the administration of the investigational drug at the baseline visit.

    Measured: From the baseline visit through 24 weeks after treatment initiation.

  3. Disease Progression Rate

    Proportion of patients with disease progression (defined as the need for mechanical ventilation, extracorporeal membrane oxygenation [ECMO], or death) at 1 month following LB-DTK-COV19 administration.

    Measured: From the screening visit through 24 weeks after treatment initiation.

  4. WHO Ordinal Scale

    The time to improvement in the World Health Organization (WHO) Ordinal Scale, defined as an improvement of at least 1 point from baseline, will be assessed. The WHO Ordinal Scale ranges from 0 (uninfected, with no viral RNA detected) to 10 (death), with higher scores indicating greater disease severity. The outcome is summarized by both the time to improvement and the proportion of participants achieving the improvement by four weeks following LB-DTK-COV19 infusion.

    Measured: From the screening visit through 24 weeks after treatment initiation.

  5. NEWS2 Score

    The time to achievement of a National Early Warning Score 2 (NEWS2) of 0 sustained for at least 24 hours is assessed. The NEWS2 score ranges from 0 (requiring routine monitoring) to 20 (emergent transport to hospital), with higher scores indicating greater degree of illness of a patient. The outcome is summarized by both the time to achievement and the proportion of participants achieving the endpoint by four weeks following LB-DTK-COV19 infusion.

    Measured: From the screening visit through 24 weeks after treatment initiation.

  6. Viral load

    Nasopharyngeal swab samples were used for PCR testing to assess SARS-CoV-2 viral load.

    Measured: From the screening visit through 24 weeks after treatment initiation.

  7. SARS-CoV2-Specific T-cell Responses

    SARS-CoV2-specific T-cell responses are assessed using IFN-γ ELISPOT assay and spot-forming units.

    Measured: From the screening visit through 24 weeks after treatment initiation.

  8. Characterization of SARS-CoV-2-Specific T cells

    SARS-CoV-2-specific T cell subsets are characterized using flow cytometry.

    Measured: From the screening visit through 24 weeks after treatment initiation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2026
  2. Study start31 Jul 2025
  3. Primary completion31 Oct 2026 (estimated)
  4. Study completion31 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07709637
Sponsor's protocol ID
LB-CL-PB-DTK-COV19-002
Status last verified
Aug 2026
First submitted
12 Jul 2026
Last updated
26 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • HG Lee and HE Chung. [COVID-19 Scientific Report]_Vol.9: Coronavirus, in the end, it is immunity <Part 2>. IBS Institute for Basic Science, 2020.

  • MY Kim, GS Park, YJ Kim, et al. First Analysis Report on Clinical Information of COVID-19. Public Health Weekly Report 2020; 13(28): 2047-2058

  • P Lulla, Baylor College of Medicine. Anti-SARS Cov-2 T Cell Infusions for COVID 19 (BATIT) (https://www.clinicaltrials.gov/ct2/show/NCT04401410). 2020.

  • Akbar MR, Pranata R, Wibowo A, Lim MA, Sihite TA, Martha JW. The prognostic value of elevated creatine kinase to predict poor outcome in patients with COVID-19 - A systematic review and meta-analysis. Diabetes Metab Syndr. 2021 Mar-Apr;15(2):529-534. doi: 10.1016/j.dsx.2021.02.012. Epub 2021 Feb 11.

    PubMed 33668003

  • Centers for Disease Control and Prevention, Reinfection with COVID-19 (https://www.cdc.gov/coronavirus/2019-ncov/your-health/reinfection.html). 2020.

  • Velavan TP, Meyer CG. Mild versus severe COVID-19: Laboratory markers. Int J Infect Dis. 2020 Jun;95:304-307. doi: 10.1016/j.ijid.2020.04.061. Epub 2020 Apr 25.

    PubMed 32344011

  • Feingold KR. Lipid and Lipoprotein Levels in Patients with Covid-19 Infections. 2026 Jan 15. In: Feingold KR, Adler RA, Ahmed SF, Anawalt B, Blackman MR, Chrousos G, Corpas E, de Herder WW, Dhatariya K, Dungan K, Hamilton E, Hofland J, Jan de Beur S, Kalra S, Kaltsas G, Kapoor N, Kim M, Koch C, Kopp P, Korbonits M, Kovacs CS, Kuohung W, Laferrere B, Levy M, McGee EA, McLachlan R, Muzumdar R, Purnell J, Rey R, Sahay R, Shah AS, Sperling MA, Stratakis CA, Trence DL, Wilson DP, editors. Endotext [Internet]. South Dartmouth (MA): MDText.com, Inc.; 2000-. Available from http://www.ncbi.nlm.nih.gov/books/NBK564657/

    PubMed 33237691

  • Oxford university hospital, Diagnosis and Management of Acute Graft Versus Host Disease. 2018.

  • Villarreal CD, Alanis JC, Perez JC, Candiani JO. Cutaneous graft-versus-host disease after hematopoietic stem cell transplant - a review. An Bras Dermatol. 2016 May-Jun;91(3):336-43. doi: 10.1590/abd1806-4841.20164180.

    PubMed 27438202

  • Riegler LL, Jones GP, Lee DW. Current approaches in the grading and management of cytokine release syndrome after chimeric antigen receptor T-cell therapy. Ther Clin Risk Manag. 2019 Feb 28;15:323-335. doi: 10.2147/TCRM.S150524. eCollection 2019.

    PubMed 30880998

  • Ghosh AK, Chen DH, Guha A, Mackenzie S, Walker JM, Roddie C. CAR T Cell Therapy-Related Cardiovascular Outcomes and Management: Systemic Disease or Direct Cardiotoxicity? JACC CardioOncol. 2020 Mar 17;2(1):97-109. doi: 10.1016/j.jaccao.2020.02.011. eCollection 2020 Mar.

    PubMed 34396213

  • Admiraal R, Nierkens S, de Witte MA, Petersen EJ, Fleurke GJ, Verrest L, Belitser SV, Bredius RGM, Raymakers RAP, Knibbe CAJ, Minnema MC, van Kesteren C, Kuball J, Boelens JJ. Association between anti-thymocyte globulin exposure and survival outcomes in adult unrelated haemopoietic cell transplantation: a multicentre, retrospective, pharmacodynamic cohort analysis. Lancet Haematol. 2017 Apr;4(4):e183-e191. doi: 10.1016/S2352-3026(17)30029-7. Epub 2017 Mar 16.

    PubMed 28330607

  • Korean Society for Laboratory Medicine, Korean Disease Control and Prevention Agency. Guidelines for the Laboratory Diagnosis of Coronavirus Disease-2019, 4th Edition. 2020

  • The Korean Society of Infectious Diseases. Korean Society of Infectious Diseases Guidelines for the Pharmacological Treatment of Coronavirus Disease 2019 (COVID-19) (Summary) (version 2.0). 2020

  • Ministry of Food and Drug Safety. Considerations in COVID-19 Drug Development. 2020

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LB-DTK-COV19 in people with COVID-19 and COVID-19 (SARS-CoV-2 Infection), run by LucasBio at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 34 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

NCI-CTCAE v5.0 ≥ Grade 3 Rate (time frame: From baseline visit through 24 weeks after treatment initiation.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07709637, which also lists 30 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.

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