BKV InfectionNCT07685457
Evaluation of Safety and Efficacy of Virus Specific T-Cell Administration in Pediatric Patients With Systemic Viral Infection Following Allogeneic Hematopoietic Stem Cell Transplantation.
A study testing LB-DTK-MV in people with BKV Infection and CMV Infection, run by LucasBio at 1 site in South Korea.
Trial summary
The goal of this prospective clinical study is to evaluate the safety and efficacy of Multi-Virus Specific T cells (LB-DTK-MV) in pediatric patients with systemic viral infection, including CMV, EBV, and BKV, after allogeneic hematopoietic stem cell transplantation (allo-HSCT). Read more about this study
- Who is it for?
- Ages 1 year to 25 years
- Conditions the study is for
- BKV Infection, CMV Infection, EBV 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
- 6 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Feb 2026to 20 May 2027
- Phase
- Interventional
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 1 year to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with CMV, EBV, and/or BKV infection that is resistant or refractory to standard-of-care treatment and associated with severe complications following allogeneic hematopoietic stem cell transplantation at the ages of 1-25 years.
- 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 who have undergone allogeneic hematopoietic stem cell transplantation at least 21 days prior to the screening visit.
- Patients who show complete donor chimerism (PCR-short tandem repeats ≥ 95%) at the time of first dose administration.
- Patients who are able to reduce their steroid dosage to 0.5mg/kg/day of Prednisolone (or an equivalent dose) or less.
- Individuals who have voluntarily decided to participate in this clinical study and have provided written consent to comply with the restrictions.
- For women of childbearing potential, those who tested negative on a pregnancy test (blood test) performed on the screening visit.
- Individuals deemed suitable as study 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.
- Patients with organ failures and/or uncontrolled bacterial or fungal infections.
- 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 who have undergone allogeneic hematopoietic stem cell transplantation or received donor lymphocyte infusion (DLI) within 28 days prior to the scheduled first dose.
- Patients with active graft-versus-host disease (GvHD) of grade 2 or higher.
- Patients with active malignant tumor or uncontrolled recurrence.
- Patients deemed ineligible for participation in this clinical study 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
Jae-won Yoo, MD-PhD
About this study
Official title: A Prospective Clinical Study to Evaluate the Safety and Efficacy of Virus Specific T-Cell Administration in Pediatric Patients With Systemic Viral Infection Following Allogeneic Hematopoietic Stem Cell Transplantation.
The goal of this prospective clinical study is to evaluate the safety and efficacy of Multi-Virus Specific T cells (LB-DTK-MV) in pediatric patients with systemic viral infection, including CMV, EBV, and BKV, after 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?
- What treatment emergent adverse events occur within 14 days after the second infusion?
- Is there a clinically significant reduction in CMV, EBV, and BKV viral loads within 14 days following the second infusion?
- Is there a clinically significant improvement in clinical symptoms within 14 days following 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 infusion.
- Conditions
- BKV Infection, CMV Infection, EBV Infection
- Being tested
- LB-DTK-MV
- Keywords
- CMV, EBV, BKV, Allogeneic Hematopoietic Stem Cell Transplantation, Virus-specific T cells, Infections, Systemic viral infection
- Medical subject headings
- Cytomegalovirus Infections, Epstein-Barr Virus Infections, Infections
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 a virus-specific T cell therapy product derived from a designated donor and is stored frozen in a colorless, transparent freeze-dried vial 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 infusion.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group (All, ped) | 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.
Viral Load
CMV, EBV, and BKV viral load testing is performed using RT-PCR on blood, urine, and/or tissue 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 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 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 (Visit 2).
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 posted6 Jul 2026
- Study start10 Feb 2026
- Primary completion20 May 2027 (estimated)
- Study completion20 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (60)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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LucasBio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, JaeWon Yoo, The Catholic University of Korea
- Investigators
- Jae-won Yoo, MD-PhD, Principal investigator, Department of Pediatrics, The Catholic University of Korea Seoul St.Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685457
- Sponsor's protocol ID
- LB-DD-DTK-MV-HS-PD-CR
- Status last verified
- Jun 2026
- First submitted
- 29 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jahangiri, V., et al., Post Transplantation Cyclophosphamide (PTCY) Is Associated with Increased Risk of BK Virus-Associated Hemorrhagic Cystitis (BKHC) in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant (HSCT).Biology of Blood and Marrow Transplantation, 2019. 25(3): p. S359-S360.
Melenhorst JJ, Leen AM, Bollard CM, Quigley MF, Price DA, Rooney CM, Brenner MK, Barrett AJ, Heslop HE. Allogeneic virus-specific T cells with HLA alloreactivity do not produce GVHD in human subjects. Blood. 2010 Nov 25;116(22):4700-2. doi: 10.1182/blood-2010-06-289991. Epub 2010 Aug 13.
PubMed 20709906Martits-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 34910857Neller MA, Ambalathingal GR, Hamad N, Sasadeusz J, Pearson R, Holmes-Liew CL, Singhal D, Tunbridge M, Ng WY, Sharplin K, Moore A, Deambrosis D, Soosay-Raj T, McNaughton P, Whyte M, Fraser C, Grigg A, Kliman D, Bajel A, Cummins K, Dowling M, Yeoh ZH, Harrison SJ, Khot A, Tan S, Roos I, Koo RM, Dohrmann S, Ritchie D, Wainstein B, McCleary K, Nelson A, Gardiner B, Inam S, Badoux X, Ma K, Toro C, Hanna D, Hughes D, Conyers R, Cole T, Wang SS, Chee L, Fleming J, Irish A, Purtill D, Cooney J, Shaw P, Tey SK, Hunt S, Subramonia Pillai E, John G, Ng M, Ramachandran S, Hopkins P, Chambers D, Campbell S, Francis R, Isbel N, Marlton P, Reddiex H, Matthews KK, Voogt M, Panikkar A, Beagley L, Rehan S, Best S, Raju J, Le Texier L, Crooks P, Solomon M, Lekieffre L, Srihari S, Smith C, Khanna R. Compassionate access to virus-specific T cells for adoptive immunotherapy over 15 years. Nat Commun. 2024 Dec 3;15(1):10339. doi: 10.1038/s41467-024-54595-2.
PubMed 39627190Liu J, Chang YJ, Yan CH, Xu LP, Jiang ZF, Zhang XH, Liu KY, Huang XJ. Poor CMV-specific CD8+ T central memory subset recovery at early stage post-HSCT associates with refractory and recurrent CMV reactivation. J Infect. 2016 Sep;73(3):261-70. doi: 10.1016/j.jinf.2016.04.033. Epub 2016 Jun 14.
PubMed 27311748Li CR, Greenberg PD, Gilbert MJ, Goodrich JM, Riddell SR. Recovery of HLA-restricted cytomegalovirus (CMV)-specific T-cell responses after allogeneic bone marrow transplant: correlation with CMV disease and effect of ganciclovir prophylaxis. Blood. 1994 Apr 1;83(7):1971-9.
PubMed 8142663Hakki M, Riddell SR, Storek J, Carter RA, Stevens-Ayers T, Sudour P, White K, Corey L, Boeckh M. Immune reconstitution to cytomegalovirus after allogeneic hematopoietic stem cell transplantation: impact of host factors, drug therapy, and subclinical reactivation. Blood. 2003 Oct 15;102(8):3060-7. doi: 10.1182/blood-2002-11-3472. Epub 2003 Jul 3.
PubMed 12843000Gratama JW, van Esser JW, Lamers CH, Tournay C, Lowenberg B, Bolhuis RL, Cornelissen JJ. Tetramer-based quantification of cytomegalovirus (CMV)-specific CD8+ T lymphocytes in T-cell-depleted stem cell grafts and after transplantation may identify patients at risk for progressive CMV infection. Blood. 2001 Sep 1;98(5):1358-64. doi: 10.1182/blood.v98.5.1358.
PubMed 11520783Cwynarski K, Ainsworth J, Cobbold M, Wagner S, Mahendra P, Apperley J, Goldman J, Craddock C, Moss PA. Direct visualization of cytomegalovirus-specific T-cell reconstitution after allogeneic stem cell transplantation. Blood. 2001 Mar 1;97(5):1232-40. doi: 10.1182/blood.v97.5.1232.
PubMed 11222365Lilleri D, Fornara C, Chiesa A, Caldera D, Alessandrino EP, Gerna G. Human cytomegalovirus-specific CD4+ and CD8+ T-cell reconstitution in adult allogeneic hematopoietic stem cell transplant recipients and immune control of viral infection. Haematologica. 2008 Feb;93(2):248-56. doi: 10.3324/haematol.11912.
PubMed 18245650Ljungman P, Boeckh M, Hirsch HH, Josephson F, Lundgren J, Nichols G, Pikis A, Razonable RR, Miller V, Griffiths PD; Disease Definitions Working Group of the Cytomegalovirus Drug Development Forum. Definitions of Cytomegalovirus Infection and Disease in Transplant Patients for Use in Clinical Trials. Clin Infect Dis. 2017 Jan 1;64(1):87-91. doi: 10.1093/cid/ciw668. Epub 2016 Sep 28.
PubMed 27682069Seo S, Smith C, Fraser C, Patheja R, Shah SP, Rehan S, Crooks P, Neller MA, Khanna R. Adoptive T-cell therapy for pediatric cytomegalovirus-associated retinitis. Blood Adv. 2019 Jun 11;3(11):1774-1777. doi: 10.1182/bloodadvances.2019000121.
PubMed 31186253Saban T, Shargian L, Eiger-Moscovitch M, Prockop S, Doubrovina E, Yeshurun M, Kramer M. Case Report: Cytomegalovirus-specific T-lymphocyte infusion for resistant cytomegalovirus retinitis. Front Ophthalmol (Lausanne). 2023 Jul 3;3:1131674. doi: 10.3389/fopht.2023.1131674. eCollection 2023.
PubMed 38983025Pei XY, Zhao XY, Chang YJ, Liu J, Xu LP, Wang Y, Zhang XH, Han W, Chen YH, Huang XJ. Cytomegalovirus-Specific T-Cell Transfer for Refractory Cytomegalovirus Infection After Haploidentical Stem Cell Transplantation: The Quantitative and Qualitative Immune Recovery for Cytomegalovirus. J Infect Dis. 2017 Nov 15;216(8):945-956. doi: 10.1093/infdis/jix357.
PubMed 29029297Mo W, Liang Y, Wang C, Zhang Y. A Simplified CMV-specific T Cell Transfer Targeting Drug-resistant CMV Retinitis. Ocul Immunol Inflamm. 2022 Aug;30(6):1541-1543. doi: 10.1080/09273948.2021.1900876. Epub 2021 Mar 18.
PubMed 33734935