COVID-19NCT07690943
Evaluation of the Safety and Efficacy of Autologous COVID-19 Antigen Specific T Cell in Prolonged SARS-CoV-2 Patients
A 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.
Trial summary
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. 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
- 13 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Jun 2023to 22 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients aged 19 years or older.
- 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 Patients who test negative for COVID-19 will be withdrawn from the study.
- Patients who fulfill Inclusion Criteria 2) and are moderately immunocompromised.
- Patients who fulfill Inclusion Criteria 2) and are refractory to standard of care (including steroids, immunosuppressants, etc depending on the severity of the disease).
- Patients with a life expectancy longer than 3 months.
- Patients who have voluntarily decided to participate in this clinical study and have provided written consent to comply with the restrictions.
Who cannot join
- 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.
- Patients with lung diseases other than COVID-19 pneumonia (including chronic obstructive pulmonary disease, asthma, cystic lung disease, tuberculosis, etc)
- Female subjects who are pregnant, breastfeeding, of childbearing potential, or not using appropriate contraceptive methods.
- Patients with active infection or fever (≥38°C) of unknown etiology, or ongoing bacterial or fungal infection.
Show all 17Show fewer
- Patients aged less than 19 years.
- 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
- Patients with mental illness or drug intoxication that may affect the results of this clinical study.
- Patients who are participating in another clinical study.
- Patients deemed ineligible for participation in this clinical study by the investigator.
- Patients with other severe medical conditions that may compromise compliance with the clinical study.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University of Korea Seoul St.Mary's Hospital
Seoul, 06591
About this study
Official title: 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?
Read more
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.
- Conditions
- COVID-19, COVID-19 (SARS-CoV-2 Infection)
- Being tested
- LB-DTK-COV19
- Keywords
- SARS-CoV-2 Infection, Infections, Virus Diseases, T-lymphocytes, Immunocompromised host, Adoptive transfer
- Medical subject headings
- COVID-19, Infections, Virus Diseases
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 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.
| Study group | Role | What they receive |
|---|---|---|
| LB-DTK-COV19 | Experimental | Not described Receives: Biological: LB-DTK-COV19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral load
Nasopharyngeal swab samples were used for PCR testing and ELISA to assess SARS-CoV-2 viral load and immunoglobulin levels.
Measured: From the screening visit through 24 weeks after treatment initiation.
WHO Ordinal Scale
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.
Measured: From the screening visit through 24 weeks after treatment initiation.
NEWS2 Score
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.
Measured: From the screening visit through 24 weeks after treatment initiation.
Chest CT Severity Score
Proportion of patients with improvement in chest CT severity scores at four weeks following LB-DTK-COV19 infusion is measured.
Measured: From the screening visit through 24 weeks after treatment initiation.
Quantification of SARS-CoV-2-Specific T cells
SARS-CoV-2-specific T cells and their subsets are quantified using flow cytometry.
Measured: From the baseline visit through 24 weeks after treatment initiation.
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 baseline through 24 weeks after treatment initiation.
Adverse Events
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.
Measured: From the baseline 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.
- First posted8 Jul 2026
- Study start8 Jun 2023
- Primary completion31 May 2024
- Study completion22 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- LucasBio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, RaeSeok Lee, The Catholic University of Korea
- Investigators
- Rae Seok Lee, MD-PhD, Principal investigator, Department of Infectious Disease, The Catholic University of Korea Seoul St.Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07690943
- Sponsor's protocol ID
- LB-AT-DTK-COV19-AD-CR
- Status last verified
- Jul 2026
- First submitted
- 30 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim N, Lee JM, Oh EJ, Jekarl DW, Lee DG, Im KI, Cho SG. Off-the-Shelf Partial HLA Matching SARS-CoV-2 Antigen Specific T Cell Therapy: A New Possibility for COVID-19 Treatment. Front Immunol. 2021 Dec 23;12:751869. doi: 10.3389/fimmu.2021.751869. eCollection 2021.
PubMed 35003063Basar R, Uprety N, Ensley E, Daher M, Klein K, Martinez F, Aung F, Shanley M, Hu B, Gokdemir E, Nunez Cortes AK, Mendt M, Reyes Silva F, Acharya S, Laskowski T, Muniz-Feliciano L, Banerjee PP, Li Y, Li S, Melo Garcia L, Lin P, Shaim H, Yates SG, Marin D, Kaur I, Rao S, Mak D, Lin A, Miao Q, Dou J, Chen K, Champlin RE, Shpall EJ, Rezvani K. Generation of glucocorticoid-resistant SARS-CoV-2 T cells for adoptive cell therapy. Cell Rep. 2021 Jul 20;36(3):109432. doi: 10.1016/j.celrep.2021.109432. Epub 2021 Jul 7.
PubMed 34270918Keller MD, Harris KM, Jensen-Wachspress MA, Kankate VV, Lang H, Lazarski CA, Durkee-Shock J, Lee PH, Chaudhry K, Webber K, Datar A, Terpilowski M, Reynolds EK, Stevenson EM, Val S, Shancer Z, Zhang N, Ulrey R, Ekanem U, Stanojevic M, Geiger A, Liang H, Hoq F, Abraham AA, Hanley PJ, Cruz CR, Ferrer K, Dropulic L, Gangler K, Burbelo PD, Jones RB, Cohen JI, Bollard CM. SARS-CoV-2-specific T cells are rapidly expanded for therapeutic use and target conserved regions of the membrane protein. Blood. 2020 Dec 17;136(25):2905-2917. doi: 10.1182/blood.2020008488.
PubMed 33331927Cooper RS, Fraser AR, Smith L, Burgoyne P, Imlach SN, Jarvis LM, Turner DM, Zahra S, Turner ML, Campbell JDM. Rapid GMP-Compliant Expansion of SARS-CoV-2-Specific T Cells From Convalescent Donors for Use as an Allogeneic Cell Therapy for COVID-19. Front Immunol. 2021 Jan 8;11:598402. doi: 10.3389/fimmu.2020.598402. eCollection 2020.
PubMed 33488592Ferreras C, Pascual-Miguel B, Mestre-Duran C, Navarro-Zapata A, Clares-Villa L, Martin-Cortazar C, De Paz R, Marcos A, Vicario JL, Balas A, Garcia-Sanchez F, Eguizabal C, Solano C, Mora-Rillo M, Soria B, Perez-Martinez A. SARS-CoV-2-Specific Memory T Lymphocytes From COVID-19 Convalescent Donors: Identification, Biobanking, and Large-Scale Production for Adoptive Cell Therapy. Front Cell Dev Biol. 2021 Feb 25;9:620730. doi: 10.3389/fcell.2021.620730. eCollection 2021.
PubMed 33718360Guerreiro M, Aguilar-Gallardo C, Montoro J, Frances-Gomez C, Latorre V, Luna I, Planelles D, Carrasco MP, Gomez MD, Gonzalez-Barbera EM, Aguado C, Sempere A, Solves P, Gomez-Segui I, Balaguer-Rosello A, Louro A, Perla A, Larrea L, Sanz J, Arbona C, de la Rubia J, Geller R, Sanz MA, Sanz G, Luis Pinana J. Adoptive transfer of ex vivo expanded SARS-CoV-2-specific cytotoxic lymphocytes: A viable strategy for COVID-19 immunosuppressed patients? Transpl Infect Dis. 2021 Aug;23(4):e13602. doi: 10.1111/tid.13602. Epub 2021 Mar 31.
PubMed 33728702Papayanni PG, Chasiotis D, Koukoulias K, Georgakopoulou A, Iatrou A, Gavriilaki E, Giannaki C, Bitzani M, Geka E, Tasioudis P, Chloros D, Fylaktou A, Kioumis I, Triantafyllidou M, Dimou-Besikli S, Karavalakis G, Boutou AK, Siotou E, Anagnostopoulos A, Papadopoulou A, Yannaki E. Vaccinated and Convalescent Donor-Derived Severe Acute Respiratory Syndrome Coronavirus 2-Specific T Cells as Adoptive Immunotherapy for High-Risk Coronavirus Disease 2019 Patients. Clin Infect Dis. 2021 Dec 6;73(11):2073-2082. doi: 10.1093/cid/ciab371.
PubMed 33905481Perez-Martinez A, Mora-Rillo M, Ferreras C, Guerra-Garcia P, Pascual-Miguel B, Mestre-Duran C, Borobia AM, Carcas AJ, Queiruga-Parada J, Garcia I, Sanchez-Zapardiel E, Gasior M, De Paz R, Marcos A, Vicario JL, Balas A, Moreno MA, Eguizabal C, Solano C, Arribas JR, Buckley RM, Montejano R, Soria B. Phase I dose-escalation single centre clinical trial to evaluate the safety of infusion of memory T cells as adoptive therapy in COVID-19 (RELEASE). EClinicalMedicine. 2021 Sep;39:101086. doi: 10.1016/j.eclinm.2021.101086. Epub 2021 Aug 13.
PubMed 34405140Martits-Chalangari K, Spak CW, Askar M, Killian A, Fisher TL, Atillasoy E, Marshall WL, McNeel D, Miller MD, Mathai SK, Gottlieb RL. ALVR109, an off-the-shelf partially HLA matched SARS-CoV-2-specific T cell therapy, to treat refractory severe COVID-19 pneumonia in a heart transplant patient: Case report. Am J Transplant. 2022 Apr;22(4):1261-1265. doi: 10.1111/ajt.16927. Epub 2021 Dec 27.
PubMed 34910857Lee CY, Shah MK, Hoyos D, Solovyov A, Douglas M, Taur Y, Maslak P, Babady NE, Greenbaum B, Kamboj M, Vardhana SA. Prolonged SARS-CoV-2 Infection in Patients with Lymphoid Malignancies. Cancer Discov. 2022 Jan;12(1):62-73. doi: 10.1158/2159-8290.CD-21-1033. Epub 2021 Nov 9.
PubMed 34753749Lee R, Kim N, Kim WB, Im KI, Nho D, Cho SY, Park C, Beck KS, Lee G, Lee I, Cho SG, Lee DG. Effectiveness and Safety of Autologous Virus-Specific T-Cell Therapy for Persistent COVID-19 in People With Immunocompromise: A Clinical Trial Study. Clin Infect Dis. 2026 Feb 4;81(6):e510-e514. doi: 10.1093/cid/ciaf302.
PubMed 40493744
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07690943
- Acronym / sponsor ID
- LB-AT-DTK-COV19-AD-CR
- Conditions
- COVID-19, COVID-19 (SARS-CoV-2 Infection)
- Keywords
- SARS-CoV-2 Infection, Infections, Virus Diseases, T-lymphocytes, Immunocompromised host, Adoptive transfer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- LucasBioIndustry (pharma, biotech, devices)
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 22 Jan 2025 (actual)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LB-DTK-COV19 | Experimental | Biological: LB-DTK-COV19 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged 19 years or older.
- 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.
- Patients who fulfill Inclusion Criteria 2) and are moderately immunocompromised.
- Patients who fulfill Inclusion Criteria 2) and are refractory to standard of care (including steroids, immunosuppressants, etc depending on the severity of the disease).
- Patients with a life expectancy longer than 3 months.
Key exclusion criteria (17 listed)
- Critically ill patients (WHO ordinal scale, category 7 or higher) who meet any of the following criteria:
- Patients with lung diseases other than COVID-19 pneumonia (including chronic obstructive pulmonary disease, asthma, cystic lung disease, tuberculosis, etc)
- Female subjects who are pregnant, breastfeeding, of childbearing potential, or not using appropriate contraceptive methods.
- Patients with active infection or fever (≥38°C) of unknown etiology, or ongoing bacterial or fungal infection.
- Patients aged less than 19 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | LB-DTK-COV19 |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Background: PubMed 35003063Kim N, Lee JM, Oh EJ, Jekarl DW, Lee DG, Im KI, Cho SG. Off-the-Shelf Partial HLA Matching SARS-CoV-2 Antigen Specific T Cell Therapy: A New Possibility for COVID-19 Treatment. Front Immunol. 2021 Dec 23;12:751869. doi: 10.3389/fimmu.2021.751869. eCollection 2021.
- Background: PubMed 34270918Basar R, Uprety N, Ensley E, Daher M, Klein K, Martinez F, Aung F, Shanley M, Hu B, Gokdemir E, Nunez Cortes AK, Mendt M, Reyes Silva F, Acharya S, Laskowski T, Muniz-Feliciano L, Banerjee PP, Li Y, Li S, Melo Garcia L, Lin P, Shaim H, Yates SG, Marin D, Kaur I, Rao S, Mak D, Lin A, Miao Q, Dou J, Chen K, Champlin RE, Shpall EJ, Rezvani K. Generation of glucocorticoid-resistant SARS-CoV-2 T cells for adoptive cell therapy. Cell Rep. 2021 Jul 20;36(3):109432. doi: 10.1016/j.celrep.2021.109432. Epub 2021 Jul 7.
- Background: PubMed 33331927Keller MD, Harris KM, Jensen-Wachspress MA, Kankate VV, Lang H, Lazarski CA, Durkee-Shock J, Lee PH, Chaudhry K, Webber K, Datar A, Terpilowski M, Reynolds EK, Stevenson EM, Val S, Shancer Z, Zhang N, Ulrey R, Ekanem U, Stanojevic M, Geiger A, Liang H, Hoq F, Abraham AA, Hanley PJ, Cruz CR, Ferrer K, Dropulic L, Gangler K, Burbelo PD, Jones RB, Cohen JI, Bollard CM. SARS-CoV-2-specific T cells are rapidly expanded for therapeutic use and target conserved regions of the membrane protein. Blood. 2020 Dec 17;136(25):2905-2917. doi: 10.1182/blood.2020008488.
- Background: PubMed 33488592Cooper RS, Fraser AR, Smith L, Burgoyne P, Imlach SN, Jarvis LM, Turner DM, Zahra S, Turner ML, Campbell JDM. Rapid GMP-Compliant Expansion of SARS-CoV-2-Specific T Cells From Convalescent Donors for Use as an Allogeneic Cell Therapy for COVID-19. Front Immunol. 2021 Jan 8;11:598402. doi: 10.3389/fimmu.2020.598402. eCollection 2020.
- Background: PubMed 33718360Ferreras C, Pascual-Miguel B, Mestre-Duran C, Navarro-Zapata A, Clares-Villa L, Martin-Cortazar C, De Paz R, Marcos A, Vicario JL, Balas A, Garcia-Sanchez F, Eguizabal C, Solano C, Mora-Rillo M, Soria B, Perez-Martinez A. SARS-CoV-2-Specific Memory T Lymphocytes From COVID-19 Convalescent Donors: Identification, Biobanking, and Large-Scale Production for Adoptive Cell Therapy. Front Cell Dev Biol. 2021 Feb 25;9:620730. doi: 10.3389/fcell.2021.620730. eCollection 2021.
- Background: PubMed 33728702Guerreiro M, Aguilar-Gallardo C, Montoro J, Frances-Gomez C, Latorre V, Luna I, Planelles D, Carrasco MP, Gomez MD, Gonzalez-Barbera EM, Aguado C, Sempere A, Solves P, Gomez-Segui I, Balaguer-Rosello A, Louro A, Perla A, Larrea L, Sanz J, Arbona C, de la Rubia J, Geller R, Sanz MA, Sanz G, Luis Pinana J. Adoptive transfer of ex vivo expanded SARS-CoV-2-specific cytotoxic lymphocytes: A viable strategy for COVID-19 immunosuppressed patients? Transpl Infect Dis. 2021 Aug;23(4):e13602. doi: 10.1111/tid.13602. Epub 2021 Mar 31.
- Background: PubMed 33905481Papayanni PG, Chasiotis D, Koukoulias K, Georgakopoulou A, Iatrou A, Gavriilaki E, Giannaki C, Bitzani M, Geka E, Tasioudis P, Chloros D, Fylaktou A, Kioumis I, Triantafyllidou M, Dimou-Besikli S, Karavalakis G, Boutou AK, Siotou E, Anagnostopoulos A, Papadopoulou A, Yannaki E. Vaccinated and Convalescent Donor-Derived Severe Acute Respiratory Syndrome Coronavirus 2-Specific T Cells as Adoptive Immunotherapy for High-Risk Coronavirus Disease 2019 Patients. Clin Infect Dis. 2021 Dec 6;73(11):2073-2082. doi: 10.1093/cid/ciab371.
- Background: PubMed 34405140Perez-Martinez A, Mora-Rillo M, Ferreras C, Guerra-Garcia P, Pascual-Miguel B, Mestre-Duran C, Borobia AM, Carcas AJ, Queiruga-Parada J, Garcia I, Sanchez-Zapardiel E, Gasior M, De Paz R, Marcos A, Vicario JL, Balas A, Moreno MA, Eguizabal C, Solano C, Arribas JR, Buckley RM, Montejano R, Soria B. Phase I dose-escalation single centre clinical trial to evaluate the safety of infusion of memory T cells as adoptive therapy in COVID-19 (RELEASE). EClinicalMedicine. 2021 Sep;39:101086. doi: 10.1016/j.eclinm.2021.101086. Epub 2021 Aug 13.
- Background: PubMed 34910857Martits-Chalangari K, Spak CW, Askar M, Killian A, Fisher TL, Atillasoy E, Marshall WL, McNeel D, Miller MD, Mathai SK, Gottlieb RL. ALVR109, an off-the-shelf partially HLA matched SARS-CoV-2-specific T cell therapy, to treat refractory severe COVID-19 pneumonia in a heart transplant patient: Case report. Am J Transplant. 2022 Apr;22(4):1261-1265. doi: 10.1111/ajt.16927. Epub 2021 Dec 27.
- Background: PubMed 34753749Lee CY, Shah MK, Hoyos D, Solovyov A, Douglas M, Taur Y, Maslak P, Babady NE, Greenbaum B, Kamboj M, Vardhana SA. Prolonged SARS-CoV-2 Infection in Patients with Lymphoid Malignancies. Cancer Discov. 2022 Jan;12(1):62-73. doi: 10.1158/2159-8290.CD-21-1033. Epub 2021 Nov 9.
- Results publication: PubMed 40493744Lee R, Kim N, Kim WB, Im KI, Nho D, Cho SY, Park C, Beck KS, Lee G, Lee I, Cho SG, Lee DG. Effectiveness and Safety of Autologous Virus-Specific T-Cell Therapy for Persistent COVID-19 in People With Immunocompromise: A Clinical Trial Study. Clin Infect Dis. 2026 Feb 4;81(6):e510-e514. doi: 10.1093/cid/ciaf302.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rae Seok Lee, MD-PhD principal investigator
Department of Infectious Disease, The Catholic University of Korea Seoul St.Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A 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 7 inclusion and 17 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: finished, as of the sponsor's last update on 8 Jul 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Viral load (time frame: From the screening visit through 24 weeks after treatment initiation.). The study lists 7 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 NCT07690943, which also lists 11 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 8 Jul 2026.