BKV InfectionPhase 1/2NCT07670468
Evaluation of the Safety and Efficacy of LB-DTK-MV in Patients Diagnosed With Antiviral-Resistant CMV, BKV, or EBV Infection or Associated Diseases Following Anticancer Therapy or Allogeneic Hematopoietic Stem Cell Transplantation.
A Phase 1/2 study testing LB-DTK-MV in people with BKV Infection and EBV Infection, run by LucasBio at 1 site in South Korea.
Trial summary
The goal of this clinical trial is to evaluate the efficacy and safety of Multi-Virus Specific T cells (LB-DTK-MV) to treat patients diagnosed with antiviral-resistant CMV, BKV, or EBV infection or associated diseases after anticancer therapy or allogeneic hematopoietic stem cell transplantation (allo-HSCT). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- BKV Infection, EBV Infection, CMV Infection
- What is being tested?
- LB-DTK-MV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSouth Korea
- Study dates
- 4 Dec 2025to 4 Jun 2027
- Phase
- Phase 1/2
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 who have undergone myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplantation using bone marrow, single or double umbilical cord blood, or peripheral blood stem cells (PBSCs). Or patients who have undergone any of the following anticancer treatments:
- CAR-T: Kymriah, Yescarta
- Bispecific Antibody: Glofitamab, Mosunetuzumab, Teclistamab, Elranatamab, etc
- Patients diagnosed with single or multiple, antiviral-resistant CMV, BKV, and/or EBV despite receiving standard treatment.
- Patients who are able to reduce their steroid dosage to 0.5mg/kg/day of Prednisolone (or an equivalent dose) or less.
- Patients with a hemoglobin level ≥8.0g/dL.
Show all 20Show fewer
- Patients with evidence of neutrophil engraftment, defined as an absolute neutrophil count (ANC) maintained at 0.5x10^3/μL or higher for 3 consecutive days following allogeneic hematopoietic stem cell transplantation.
- Patients with peripheral oxygen saturation (SpO2) ≥90% on room air.
- Patients who have at least one MHC class I HLA allele that matches the investigational product.
- For women of childbearing potential, those who tested negative on a pregnancy test (blood test) performed on the screening visit.
- Female subjects or male subjects with female partners who agree to use the following contraceptive methods during the duration of this clinical trial and who meet the following criteria:
- Female participants or male participants with female partners who are postmenopausal (diagnosed with non-therapy-induced amenorrhea for 12 months or more or menopause)
- Female subjects or the female partners of male subjects who are surgically sterile (i.e., lacking ovaries and/or a uterus)
- Individuals who have agreed to strict abstinence during the clinical trial period [For female participants, intermittent abstinence (e.g., withdrawal during ovulation, the basal body temperature method, or withdrawal after ovulation) does not constitute agreement to abstinence]
- If the female subject or the female partner of a male subject is a woman of childbearing potential (WOCBP) who has not undergone sterilization, those who meet the following criteria:
- Hormonal contraceptives (implant, patch, oral)
- Intrauterine devices
- Dual barrier method (simultaneous use of the following two contraceptive methods: male condoms, female condoms, cervical caps, contraceptive diaphragms, contraceptive sponges)
- Individuals who have voluntarily decided to participate in this clinical trial and have provided written consent to comply with the restrictions.
- Individuals deemed suitable as trial subjects through screening tests (vital signs, physical examination, medical and surgical history, electrocardiogram, laboratory tests, etc.).
Who cannot join
- Individuals who have received treatment with ATG (Antithymocyte Globulin), Campath (Alemtuzumab), or other T-cell immunosuppressive monoclonal antibodies within 28 days prior to the first dose.
- Individuals who meet any of the following criteria at the time of screening:
- Uncontrolled hypertension
- Systolic BP ≥ 160 mmHg or diastolic BP ≥ 100 mmHg despite taking antihypertensive medication.
- Uncontrolled diabetes: Severe diabetes is defined as follows:
- Severe hyperglycemia with HbA1C ≥ 10.0%
Show all 28Show fewer
- 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 <54 mg/dL) accompanied by seizures and loss of consciousness.
- Other viral infections [Ex. Human Immunodeficiency Virus(HIV), Hepatitis B Virus(HBV), Hepatitis C Virus(HCV)]. However, patients who are tested negative for HBsAg and positive for anti-HBcAb are not subject to this exclusion criterion.
- Tuberculosis
- Syphilis
- Moderate or severe liver damage [Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) > 5 times the upper limit of normal (ULN)]
- Chronic kidney disease [eGFR < 30mL/min/1.73m^2]
- Patients with other uncontrolled infections. However, the following cases are considered controlled infections and do not meet the exclusion criteria:
- Bacterial infection. Patients must be undergoing definitive antibiotic treatment for the infection and must have shown no signs of progression of the infection for 72 hours prior to enrollment in this clinical trial.
- Fungal infection. The patient must be receiving systemic antifungal therapy and must have shown no signs of infection progression for 1 week prior to enrollment in this clinical trial.
- Patients who have undergone allogeneic hematopoietic stem cell transplantation within 28 days prior to the scheduled first dose, or who have received donor lymphocyte infusion (DLI) within 28 days prior to enrollment in this clinical trial.
- Patients with active acute graft-versus-host disease (GvHD) of grade 2 or higher.
- Patients requiring urgent anticancer therapy due to rapid tumor progression.
- Patients with a history of substance abuse within 24 weeks prior to administration of the investigational drug, or patients suspected of taking drugs of concern based on medical history and physical examination.
- Patients requiring vasopressors.
- Patients who have previously shown hypersensitivity to T-cell therapy.
- Patients with a history of autoimmune disease.
- Patients with hemophilia who are at risk of severe bleeding during administration, or patients receiving anticoagulants.
- Patients who have received another virus-specific T cell product within 28 days prior to administration of the investigational drug.
- Patients with a life expectancy of less than 24 hours at the time of the screening visit.
- Patients aged under 19.
- Patients deemed ineligible for participation in this clinical trial by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
The Catholic University of Korea Seoul St.Mary's Hospital
Seoul, 06591
Dong-Gun Lee, MD-PhD
About this study
Official title: A Single-Center, Open-Label, Phase 1/2 Clinical Trial to Evaluate the Safety and Efficacy of LB-DTK-MV in Patients Diagnosed With Antiviral-Resistant CMV, BKV, or EBV Infection or Associated Diseases Following Anticancer Therapy or Allogeneic Hematopoietic Stem Cell Transplantation.
The goal of this clinical trial is to evaluate the efficacy and safety of Multi-Virus Specific T cells (LB-DTK-MV) to treat patients diagnosed with antiviral-resistant CMV, BKV, or EBV infection or associated diseases after anticancer therapy or allogeneic hematopoietic stem cell transplantation (allo-HSCT). The main questions it aims to answer are:
- What is the maximum tolerated dose of LB-DTK-MV based on dose-limiting toxicity?
- Does the number of CMV, BKV, or EBV virus viral load decrease within 7 or 14 days after the second infusion of LB-DTK-MV?
- Do treatment emergent adverse events occur after the second infusion?
Read more
Participants will:
- Receive a single intravenous infusion of LB-DTK-MV during the baseline visit (low dose: 1x10^7/m^2; high dose: 2x10^7/m^2).
- Receive the second infusion of LB-DTK-MV intravenously at the same dose 14 days after the first infusion.
- Attend weekly follow-up visits at the clinic for 6 months after the first dose.
- Conditions
- BKV Infection, EBV Infection, CMV Infection
- Being tested
- LB-DTK-MV
- Keywords
- CMV, EBV, BKV, Multi-virus, CMV-associated diseases, EBV-associated diseases, BKV-associated diseases, Allogeneic Hematopoietic Stem Cell Transplantation, Virus-specific T cells, Infections, Virus Diseases, Antiviral-resistant infection, Anticancer therapy
- Medical subject headings
- Epstein-Barr Virus Infections, Cytomegalovirus Infections, Infections, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LB-DTK-MVBiological
LB-DTK-MV is an allogeneic cell therapy product derived from a third-party donor and is supplied as a pale-yellow cell suspension at a final concentration of 4x10^7cells/2mL in a colorless, transparent freeze-dried vial. The product is stored frozen until thawed into liquid before administration. Study participants will receive a single intravenous infusion of the assigned cell dose (low dose: 1x10^7/m^2;high dose: 2x10^7/m^2) of LB-DTK-MV on Visit 2 and 14 days after the initial dose.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group (All) | Experimental | Not described Receives: Biological: LB-DTK-MV |
What is being measured
The primary outcome is the main question the study is designed to answer.
CMV viral load
CMV viral load testing is performed using RT-PCR on blood samples. Viral load is measured weekly for the first 4 weeks, followed by two measurements at 2-week intervals to monitor the progression of the infection, then once every 4 weeks, and subsequently once every 12 weeks.
Measured: From enrollment through 24 weeks after treatment initiation
BKV viral load
BKV viral load testing is performed using RT-PCR on urine and blood samples. Viral load is measured weekly for the first 4 weeks, followed by two measurements at 2-week intervals to monitor the progression of the infection, then once every 4 weeks, and subsequently once every 12 weeks.
Measured: From enrollment through 24 weeks after treatment initiation.
EBV viral load
EBV load testing is performed using RT-PCR on blood samples. Viral load is measured weekly for the first 4 weeks, followed by two measurements at 2-week intervals to monitor the progression of the infection, then once every 4 weeks, and subsequently once every 12 weeks.
Measured: From enrollment through 24 weeks after treatment initiation.
Immunogenicity Testing
Immunogenicity testing using the IFN-γ ELISpot assay is performed weekly for the first 4 weeks following administration of the investigational drug. Thereafter, to evaluate the persistence and reconstitution of the immune response, measurements are taken twice at 2-week intervals, once at 4-week intervals, and once at 12-week intervals. Flow cytometry will be performed concurrently at each time point to evaluate cytokine profiles and immune cell subsets.
Measured: From enrollment through 24 weeks after treatment initiation.
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 (Visit 2); however, from the baseline visit (Visit 2) until the discharge date, adverse events shall be assessed daily, and after the discharge date, assessments shall be conducted according to the procedures for each visit; diseases or symptoms that occurred prior to the first administration of the investigational drug shall be collected as part of the medical history.
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 posted26 Jun 2026
- Study start4 Dec 2025
- Primary completion4 Jun 2027 (estimated)
- Study completion4 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for BKV InfectionStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LucasBio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dong-Gun 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
- NCT07670468
- Sponsor's protocol ID
- LB-CL-PB-DTK-MV-001
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bollard CM, Heslop HE. T-cell therapy for viral infections. Gene Ther. 2016;23(8-9):638-648.
Ljungman P, de la Camara R, Robin C, Crocchiolo R, Einsele H, Hill JA, Hubacek P, Navarro D, Cordonnier C, Ward KN; 2017 European Conference on Infections in Leukaemia group. Guidelines for the management of cytomegalovirus infection in patients with haematological malignancies and after stem cell transplantation from the 2017 European Conference on Infections in Leukaemia (ECIL 7). Lancet Infect Dis. 2019 Aug;19(8):e260-e272. doi: 10.1016/S1473-3099(19)30107-0. Epub 2019 May 29.
PubMed 31153807Tzannou I, Papadopoulou A, Naik S, Leung K, Martinez CA, Ramos CA, Carrum G, Sasa G, Lulla P, Watanabe A, Kuvalekar M, Gee AP, Wu MF, Liu H, Grilley BJ, Krance RA, Gottschalk S, Brenner MK, Rooney CM, Heslop HE, Leen AM, Omer B. Off-the-Shelf Virus-Specific T Cells to Treat BK Virus, Human Herpesvirus 6, Cytomegalovirus, Epstein-Barr Virus, and Adenovirus Infections After Allogeneic Hematopoietic Stem-Cell Transplantation. J Clin Oncol. 2017 Nov 1;35(31):3547-3557. doi: 10.1200/JCO.2017.73.0655. Epub 2017 Aug 7.
PubMed 28783452Leen AM, Bolard CM, Mendizabal AM, et al. Multicenter study of human adenovirus-specific T cells for the treatment of adenoviral infection following allogeneic HSCT. Biol Blood Marrow Transplant. 2013;19(10):1511-1520.
Papadopoulou A, Gerdemann U, Katari UL, Tzannou I, Liu H, Martinez C, Leung K, Carrum G, Gee AP, Vera JF, Krance RA, Brenner MK, Rooney CM, Heslop HE, Leen AM. Activity of broad-spectrum T cells as treatment for AdV, EBV, CMV, BKV, and HHV6 infections after HSCT. Sci Transl Med. 2014 Jun 25;6(242):242ra83. doi: 10.1126/scitranslmed.3008825.
PubMed 24964991Houghton AM, Sun L, Bennett K, et al. Severe viral infections in patients with hematologic malignancies receiving intensive chemotherapy. Leuk Lymphoma. 2019;60(11):2710-2718.
O'Reilly RJ, Prockop S, Hasan AN, et al. Virus-specific T cells to treat CMV, EBV, and ADV infections after stem cell transplantation. Blood. 2016;128(22):2590-2595.
Hill JA, Mayer BT, Xie H, et al. The clinical impact of combined cytomegalovirus, Epstein-Barr virus, and BK polyomavirus viremia after hematopoietic cell transplantation. Clin Infect Dis. 2017;64(10):1388-1395.
Cho SG, Kim N, Sohn HJ, Lee SK, Oh ST, Lee HJ, Cho HI, Yim HW, Jung SE, Park G, Oh JH, Choi BO, Kim SW, Kim SW, Chung NG, Lee JW, Hong YS, Kim TG. Long-term Outcome of Extranodal NK/T Cell Lymphoma Patients Treated With Postremission Therapy Using EBV LMP1 and LMP2a-specific CTLs. Mol Ther. 2015 Aug;23(8):1401-1409. doi: 10.1038/mt.2015.91. Epub 2015 May 28.
PubMed 26017177Simmons HZ, Bazzell AF, Dains JE. Adverse Effects of Virus-Specific T-Cell Therapy: An Integrative Review. J Adv Pract Oncol. 2019 Mar;10(2):120-131. Epub 2019 Mar 1.
PubMed 31538024Cruz CR, Hanley PJ, Liu H, Torrano V, Lin YF, Arce JA, Gottschalk S, Savoldo B, Dotti G, Louis CU, Leen AM, Gee AP, Rooney CM, Brenner MK, Bollard CM, Heslop HE. Adverse events following infusion of T cells for adoptive immunotherapy: a 10-year experience. Cytotherapy. 2010 Oct;12(6):743-9. doi: 10.3109/14653241003709686.
PubMed 20429793Green A, Rubinstein JD, Grimley M, Pfeiffer T. Virus-Specific T Cells for the Treatment of Systemic Infections Following Allogeneic Hematopoietic Cell and Solid Organ Transplantation. J Pediatric Infect Dis Soc. 2024 Feb 28;13(Supplement_1):S49-S57. doi: 10.1093/jpids/piad077.
PubMed 38417086Martits-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 34910857Vasileiou S, Hill L, Kuvalekar M, Workineh AG, Watanabe A, Velazquez Y, Lulla S, Mooney K, Lapteva N, Grilley BJ, Heslop HE, Rooney CM, Brenner MK, Eagar TN, Carrum G, Grimes KA, Leen AM, Lulla P. Allogeneic, off-the-shelf, SARS-CoV-2-specific T cells (ALVR109) for the treatment of COVID-19 in high-risk patients. Haematologica. 2023 Jul 1;108(7):1840-1850. doi: 10.3324/haematol.2022.281946.
PubMed 36373249Chandraker A, Regmi A, Gohh R, Sharma A, Woodle ES, Ansari MJ, Nair V, Chen LX, Alhamad T, Norman S, Cibrik D, Singh M, Alper A, Jain D, Zaky Z, Knechtle S, Sharfuddin A, Gupta G, Lonze BE, Young JH, Adey D, Faravardeh A, Dadhania DM, Rossi AP, Florescu D, Cardarelli F, Ma J, Gilmore S, Vasileiou S, Jindra PT, Wojciechowski D. Posoleucel in Kidney Transplant Recipients with BK Viremia: Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial. J Am Soc Nephrol. 2024 May 1;35(5):618-629. doi: 10.1681/ASN.0000000000000329. Epub 2024 Mar 12.
PubMed 38470444