Evaluation of the Safety and Efficacy of Autologous COVID-19 Antigen Specific T Cell in Prolonged SARS-CoV-2 Patients

July 6, 2026 updated by: RaeSeok Lee, LucasBio

A Clinical Study to Evaluate the Safety and Efficacy of Autologous COVID-19 Antigen Specific T Cell Treatment in Prolonged SARS-CoV-2 Infected Patients

The goal of this clinical study is to evaluate the safety and efficacy of autologous COVID-19 antigen specific T cell (LB-DTK-COV19) treatment in prolonged SARS-CoV-2 infected patients. The main questions it aims to answer are:

  • What adverse events occur after the infusion of LB-DTK-COV19?
  • Is there a clinically significant improvement in clinical symptoms within 4 weeks after the infusion?
  • Is there a clinically significant reduction in SARS-CoV-2 viral load within 4 weeks after the infusion?

The patients will:

  • Receive a single infusion of LB-DTK-COV19 either intravenously or using central venous catheter during the baseline visit at a dose of 1x10^7/m^2.
  • Receive a second infusion of LB-DTK-COV19 either intravenously or using central venous catheter at the same dose 14 days after the first infusion.
  • Attend follow-up visits at the clinic for 6 months after the first infusion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Seoul, South Korea, 06591
        • The Catholic University of Korea Seoul St.Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LB-DTK-COV19
Biological: LB-DTK-COV19
- LB-DTK-COV19 is an autologous SARS-CoV-2-specific T cell therapy product derived from a patient and is stored frozen in a colorless, transparent freeze-dried vial until thawed into liquid before administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Viral load
Time Frame: From the screening visit through 24 weeks after treatment initiation.
Nasopharyngeal swab samples were used for PCR testing and ELISA to assess SARS-CoV-2 viral load and immunoglobulin levels.
From the screening visit through 24 weeks after treatment initiation.
WHO Ordinal Scale
Time Frame: From the screening visit through 24 weeks after treatment initiation.
The time to improvement in the WHO Ordinal Scale, defined as an improvement of at least 1 point from baseline, is assessed. 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.
From the screening visit through 24 weeks after treatment initiation.
NEWS2 Score
Time Frame: From the screening visit through 24 weeks after treatment initiation.
The time to achievement of a NEWS2 score of 0 sustained for at least 24 hours is assessed. 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.
From the screening visit through 24 weeks after treatment initiation.
Chest CT Severity Score
Time Frame: From the screening visit through 24 weeks after treatment initiation.
Proportion of patients with improvement in chest CT severity scores at four weeks following LB-DTK-COV19 infusion is measured.
From the screening visit through 24 weeks after treatment initiation.
Quantification of SARS-CoV-2-Specific T cells
Time Frame: From the baseline visit through 24 weeks after treatment initiation.
SARS-CoV-2-specific T cells and their subsets are quantified using flow cytometry.
From the baseline visit through 24 weeks after treatment initiation.
SARS-CoV2-Specific T-cell Responses
Time Frame: From baseline through 24 weeks after treatment initiation.
SARS-CoV2-specific T-cell responses are assessed using IFN-γ ELISPOT assay and spot-forming units.
From baseline through 24 weeks after treatment initiation.
Adverse Events
Time Frame: From the baseline visit through 24 weeks after treatment initiation.
The investigator must confirm the occurrence of adverse events through medical examinations during regular visits throughout the clinical study period. Adverse events shall be assessed at each visit starting from the administration of the investigational drug at the baseline visit.
From the baseline visit through 24 weeks after treatment initiation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LucasBio

Investigators

  • Principal Investigator: Rae Seok Lee, MD-PhD, Department of Infectious Disease, The Catholic University of Korea Seoul St.Mary's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2023

Primary Completion (Actual)

May 31, 2024

Study Completion (Actual)

January 22, 2025

Study Registration Dates

First Submitted

June 30, 2026

First Submitted That Met QC Criteria

July 6, 2026

First Posted (Actual)

July 8, 2026

Study Record Updates

Last Update Posted (Actual)

July 8, 2026

Last Update Submitted That Met QC Criteria

July 6, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LB-AT-DTK-COV19-AD-CR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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