Hemorrhagic CystitisPhase 1/2NCT07638332
Evaluation of the Safety and Efficacy of LB-DTK-BKV in Patients With BK Virus-Associated Hemorrhagic Cystitis Following Allogeneic Hematopoietic Stem Cell Transplantation
A Phase 1/2 study testing LB-DTK-BKV and Standard-of-care in people with Hemorrhagic Cystitis, run by LucasBio at 9 sites in South Korea.
Trial summary
The goal of this clinical trial is to assess efficacy of BK virus specific T cells (LB-DTK-BKV) to treat pediatric, adolescent, and adult patients with BK virus-associated hemorrhagic cystitis after allogenic hematopoietic stem cell transplantation (allo-HSCT). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Hemorrhagic Cystitis
- What is being tested?
- LB-DTK-BKV and Standard-of-care
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 9 sitesSouth Korea
- Study dates
- 1 Sep 2026to 1 Mar 2028
- Phase
- Phase 1/2
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who have undergone allogeneic hematopoietic stem cell transplantation, including pediatric and adolescent patients as well as adults who were 12 years of age or older at the time of transplantation. However, only adults aged 19 years or older are eligible for enrollment in Phase 1.
- Patients diagnosed with BK virus-associated hemorrhagic cystitis who meet all three of the following criteria.
- Clinical symptoms and signs of cystitis, such as lower abdominal pain and dysuria
- Hematuria of grade 2 or higher according to the Bedi criteria
- Detection of BKV >7log10 copies/mL in urine
- Subjects confirmed by the investigator to be unresponsive to treatment despite at least 7 days of standard inpatient therapy.
Show all 20Show fewer
- Patients with evidence of neutrophil engraftment, defined as an absolute neutrophil count (ANC) maintained at 0.5 × 10³/μL or higher for 3 consecutive days following allogeneic hematopoietic stem cell transplantation.
- Patients for whom at least 21 days (D+21) have elapsed since allogeneic hematopoietic stem cell transplantation as of the screening date.
- Patients who are able to reduce their steroid dosage to 0.5 mg/kg/day of prednisolone (or an equivalent dose) or less.
- 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.
- Patients with hemorrhagic cystitis caused by adenovirus (excluded via urine PCR)
- Patients with bacterial growth in urine culture (excluded via bacterial culture)
- 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.
Show all 30Show fewer
- Uncontrolled diabetes: 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 <54 mg/dL) accompanied by seizures and loss of consciousness.
- Human Immunodeficiency Virus (HIV) infection
- Hepatitis B Virus (HBV) infection. However, individuals who are HBsAg-negative and Anti-HBcAb-positive are not subject to this exclusion criterion.
- Hepatitis C Virus (HCV) infection
- Tuberculosis
- Syphilis
- Moderate or severe liver damage [Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) > 5 times the upper limit of normal (ULN)]
- 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.
- Active acute graft-versus-host disease (GvHD) of grade 3 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 investigational drug within 24 weeks 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 deemed ineligible for participation in this clinical trial by the investigator.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
South Korea9 sites
Kyungpook National University Chilgok Hospital
Daegu, 41404
Joonho Moon, MD-PhD
National Cancer Center Korea
Goyang-si, 10408
Hyeon Jin Park, MD-PhD
Chonnam National University Hwasun Hospital
Hwasun, 58128
Hoon Kook, MD-PhD
Seoul National University Hospital
Seoul, Seoul, 03080
Hyoung Jin Kang, MD-PhD
Severance Hospital
Seoul, Seoul, 03722
Asan Medical Center
Seoul, Seoul, 05505
Ho-joon Im, MD-PhD
Samsung Medical Center
Seoul, Seoul, 06351
Yae-Jean Kim, MD-PhD
Ewha Womans University Seoul Hospital
Seoul, 07804
Eun Sun Yoo, MD-PhD
Ulsan University Hospital
Ulsan, 44033
Jae-Cheol Jo, 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-BKV in Patients With BK Virus-Associated Hemorrhagic Cystitis Following Allogeneic Hematopoietic Stem Cell Transplantation in Children, Adolescents, and Adults
The goal of this clinical trial is to assess efficacy of BK virus specific T cells (LB-DTK-BKV) to treat pediatric, adolescent, and adult patients with BK virus-associated hemorrhagic cystitis after allogenic hematopoietic stem cell transplantation (allo-HSCT). It will also evaluate the safety of LB-DTK-BKV using treatment-emergent adverse events (TEAEs). The main questions it aims to answer are:
- Does LB-DTK-BKV reduce the number of BKV virus viral load in allo-HSCT patients with hemorrhagic cystitis?
- Do adverse events occur after the second dose? Researchers will compare LB-DTK-BKV to a placebo to see if LB-DTK-BKV works to treat hemorrhagic cystitis in allo-HSCT patients.
Read more
Participants will:
- Receive a single intravenous infusion of LB-DTK-BKV at the baseline visit (low dose: 1x10^7/m^2; high dose: 2x10^7/m^2).
- Receive the second dose of LB-DTK-BKV intravenously at the same dose 14 days after the first dose.
- Visit the clinic every week for follow-up for 6 months after the first dose.
- Conditions
- Hemorrhagic Cystitis
- Being tested
- LB-DTK-BKV, Standard-of-care
- Keywords
- BK-Virus, Hemorrhagic Cystitis, Virus-specific T cells, Allogeneic Hematopoietic Stem Cell Transplantation, Stem Cell Transplant, Virus Diseases, Infections, Cystitis
- Medical subject headings
- Cystitis, Hemorrhagic, Virus Diseases, Infections, Cystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LB-DTK-BKVBiological
LB-DTK-BKV derived from a designated donor determined based on the type of allogeneic hematopoietic stem cell transplant the subject is undergoing. A pale yellow cell suspension filled in a colorless, transparent freeze-dried vial that 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) on Visit 2 and 14 days after the initial dose.
Standard-of-careOther
Standard-of-care therapy for BK virus-associated hemorrhagic cystitis after allogeneic hematopoietic stem cell transplantation will be administered according to the participant's clinical status by the principal investigator. Participants in the placebo group will not receive LB-DTK-BKV during the clinical trial.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Not described Receives: Biological: LB-DTK-BKV |
| Placebo Group | Placebo comparator | Not described Receives: Other: Standard-of-care |
What is being measured
The primary outcome is the main question the study is designed to answer.
BK virus viral load
BK viral load testing is performed using RT-PCR on urine 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. (That is, measurements are taken at weeks 1, 2, 3, 4, 6, 8, 12, and 24 after treatment initiation.)
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. (i.e., measurements are taken at weeks 1, 2, 3, 4, 6, 8, 12, and 24 after dosing)
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 enrollment through 24 weeks after treatment initiation.
Secondary outcomes (1)
BK virus viral load
BK 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. (That is, measurements are taken at weeks 1, 2, 3, 4, 6, 8, 12, and 24 after treatment initiation.)
Measured: From enrollment 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 posted10 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Hemorrhagic CystitisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LucasBio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yae-Jean Kim, MD-PhD, Principal investigator, Department of Pediatrics, Samsung Medical CenterHyoung Jin Kang, MD-PhD, Principal investigator, Department of Pediatric Hematology-Oncology, Seoul National University HospitalHo-joon Im, MD-PhD, Principal investigator, Department of Pediatric Hematology & Oncology, Asan Medical CenterHyeon Jin Park, MD-PhD, Principal investigator, National Cancer Center, KoreaSeung Min Hahn, MD-PhD, Principal investigator, Department of Pediatric Hematology & Oncology, Severance HospitalHoon Kook, MD-PhD, Principal investigator, Department of Pediatric Hematology & Oncology, Chonnam National University Hwasun HospitalJae-Cheol Jo, MD-PhD, Principal investigator, Department of Hematology, Ulsan University HospitalEun Sun Yoo, MD-PhD, Principal investigator, Department of Pediatric Hematology Oncology, Ewha Womans University Seoul Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07638332
- Sponsor's protocol ID
- LB-DTK-BKV-DD-001
- Status last verified
- Jul 2026
- First submitted
- 5 Jun 2026
- Last updated
- 24 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.
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 36373249Dadwal SS, Bansal R, Schuster MW, Yared JA, Myers GD, Matzko M, Adnan S, McNeel D, Ma J, Gilmore SA, Vasileiou S, Leen AM, Hill JA, Young JH. Final outcomes from a phase 2 trial of posoleucel in allogeneic hematopoietic cell transplant recipients. Blood Adv. 2024 Sep 10;8(17):4740-4750. doi: 10.1182/bloodadvances.2023011562.
PubMed 38593233Dekker L, Sanders E, Lindemans CA, de Koning C, Nierkens S. Naive T Cells in Graft Versus Host Disease and Graft Versus Leukemia: Innocent or Guilty? Front Immunol. 2022 Jun 20;13:893545. doi: 10.3389/fimmu.2022.893545. eCollection 2022.
PubMed 35795679Jalili A, Hajifathali A, Mohammadian M, Sankanian G, Sayahinouri M, Dehghani Ghorbi M, Roshandel E, Aghdami N. Virus-Specific T Cells: Promising Adoptive T Cell Therapy Against Infectious Diseases Following Hematopoietic Stem Cell Transplantation. Adv Pharm Bull. 2023 Jul;13(3):469-482. doi: 10.34172/apb.2023.046. Epub 2022 Nov 4.
PubMed 37646062Vasileiou S, Turney AM, Kuvalekar M, Mukhi SS, Watanabe A, Lulla P, Ramos CA, Naik S, Vera JF, Tzannou I, Leen AM. Rapid generation of multivirus-specific T lymphocytes for the prevention and treatment of respiratory viral infections. Haematologica. 2020 Jan;105(1):235-243. doi: 10.3324/haematol.2018.206896. Epub 2019 Apr 19. No abstract available.
PubMed 31004020Vasileiou S, Kuvalekar M, Velazquez Y, Watanabe A, Leen AM, Gilmore SA. Phenotypic and functional characterization of posoleucel, a multivirus-specific T cell therapy for the treatment and prevention of viral infections in immunocompromised patients. Cytotherapy. 2024 Aug;26(8):869-877. doi: 10.1016/j.jcyt.2024.03.012. Epub 2024 Mar 19.
PubMed 38597860Tzannou 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 28783452Pfeiffer T, Tzannou I, Wu M, Ramos C, Sasa G, Martinez C, Lulla P, Krance RA, Scherer L, Ruderfer D, Naik S, Bocchini C, Fraser IP, Patel B, Ward D, Wang T, Heslop HE, Leen AM, Omer B. Posoleucel, an Allogeneic, Off-the-Shelf Multivirus-Specific T-Cell Therapy, for the Treatment of Refractory Viral Infections in the Post-HCT Setting. Clin Cancer Res. 2023 Jan 17;29(2):324-330. doi: 10.1158/1078-0432.CCR-22-2415.
PubMed 36628536Imlay H, Xie H, Leisenring WM, Duke ER, Kimball LE, Huang ML, Pergam SA, Hill JA, Jerome KR, Milano F, Nichols WG, Pang PS, Hirsch HH, Limaye AP, Boeckh M. Presentation of BK polyomavirus-associated hemorrhagic cystitis after allogeneic hematopoietic cell transplantation. Blood Adv. 2020 Feb 25;4(4):617-628. doi: 10.1182/bloodadvances.2019000802.
PubMed 32074279
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open-Label, Phase 1/2 Clinical Trial to Evaluate the Safety and Efficacy of LB-DTK-BKV in Patients With BK Virus-Associated Hemorrhagic Cystitis Following Allogeneic Hematopoietic Stem Cell Transplantation in Children, Adolescents, and Adults
- ClinicalTrials.gov ID
- NCT07638332
- Acronym / sponsor ID
- LB-DTK-BKV-DD-001
- Conditions
- Hemorrhagic Cystitis
- Keywords
- BK-Virus, Hemorrhagic Cystitis, Virus-specific T cells, Allogeneic Hematopoietic Stem Cell Transplantation, Stem Cell Transplant, Virus Diseases, Infections, Cystitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- LucasBioIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 10 Jun 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 trial is to assess efficacy of BK virus specific T cells (LB-DTK-BKV) to treat pediatric, adolescent, and adult patients with BK virus-associated hemorrhagic cystitis after allogenic hematopoietic stem cell transplantation (allo-HSCT). It will also evaluate the safety of LB-DTK-BKV using treatment-emergent adverse events (TEAEs). The main questions it aims to answer are:
- Does LB-DTK-BKV reduce the number of BKV virus viral load in allo-HSCT patients with hemorrhagic cystitis?
- Do adverse events occur after the second dose? Researchers will compare LB-DTK-BKV to a placebo to see if LB-DTK-BKV works to treat hemorrhagic cystitis in allo-HSCT patients.
Participants will:
- Receive a single intravenous infusion of LB-DTK-BKV at the baseline visit (low dose: 1x10^7/m^2; high dose: 2x10^7/m^2).
- Receive the second dose of LB-DTK-BKV intravenously at the same dose 14 days after the first dose.
- Visit the clinic every week for follow-up for 6 months after the first dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Biological: LB-DTK-BKV |
| Placebo Group | Placebo comparator | Other: Standard-of-care |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (20 listed)
- Patients who have undergone allogeneic hematopoietic stem cell transplantation, including pediatric and adolescent patients as well as adults who were 12 years of age or older at the time of transplantation. However, only adults aged 19 years or older are eligible for enrollment in Phase 1.
- Patients diagnosed with BK virus-associated hemorrhagic cystitis who meet all three of the following criteria.
- Subjects confirmed by the investigator to be unresponsive to treatment despite at least 7 days of standard inpatient therapy.
- Patients with evidence of neutrophil engraftment, defined as an absolute neutrophil count (ANC) maintained at 0.5 × 10³/μL or higher for 3 consecutive days following allogeneic hematopoietic stem cell transplantation.
- Patients for whom at least 21 days (D+21) have elapsed since allogeneic hematopoietic stem cell transplantation as of the screening date.
Key exclusion criteria (30 listed)
- 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 hemorrhagic cystitis caused by adenovirus (excluded via urine PCR)
- Patients with bacterial growth in urine culture (excluded via bacterial culture)
- Individuals who meet any of the following criteria at the time of screening:
- 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.
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-BKVLB-DTK-BKV derived from a designated donor determined based on the type of allogeneic hematopoietic stem cell transplant the subject is undergoing. A pale yellow cell suspension filled in a colorless, transparent freeze-dried vial that 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) on Visit 2 and 14 days after the initial dose. | Biological | Experimental Group |
| Standard-of-careStandard-of-care therapy for BK virus-associated hemorrhagic cystitis after allogeneic hematopoietic stem cell transplantation will be administered according to the participant's clinical status by the principal investigator. Participants in the placebo group will not receive LB-DTK-BKV during the clinical trial. | Other | Placebo Group |
Primary outcome
BK virus viral load
Time frame: From enrollment through 24 weeks after treatment initiation.
BK viral load testing is performed using RT-PCR on urine 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. (That is, measurements are taken at weeks 1, 2, 3, 4, 6, 8, 12, and 24 after treatment initiation.)
Immunogenicity Testing
Time frame: From enrollment through 24 weeks after treatment initiation.
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. (i.e., measurements are taken at weeks 1, 2, 3, 4, 6, 8, 12, and 24 after dosing)
Adverse Events
Time frame: From enrollment through 24 weeks after treatment initiation.
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.
1 secondary outcome
BK virus viral load
Time frame: From enrollment through 24 weeks after treatment initiation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- BackgroundJahangiri, 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.
- Background: PubMed 26017177Cho 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.
- Background: PubMed 31538024Simmons 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.
- Background: PubMed 20429793Cruz 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.
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- Individual participant dataSharing planned: Undecided
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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.
Yae-Jean Kim, MD-PhD principal investigator
Department of Pediatrics, Samsung Medical Center
Hyoung Jin Kang, MD-PhD principal investigator
Department of Pediatric Hematology-Oncology, Seoul National University Hospital
Ho-joon Im, MD-PhD principal investigator
Department of Pediatric Hematology & Oncology, Asan Medical Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LB-DTK-BKV and Standard-of-care in people with Hemorrhagic Cystitis, run by LucasBio at 9 sites 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 20 inclusion and 30 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: opening soon, as of the sponsor's last update on 24 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 9 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Nayoun Kim, Ph.D. (+82 1040222340, nkim@lucasbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BK virus viral load (time frame: From enrollment through 24 weeks after treatment initiation.). The study lists 3 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 NCT07638332, which also lists 25 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 24 Jul 2026.