Evaluation of the Safety and Efficacy of LB-DTK-BKV in Patients With BK Virus-Associated Hemorrhagic Cystitis Following Allogeneic Hematopoietic Stem Cell Transplantation.

June 5, 2026 updated by: LucasBio

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 BV 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 (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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

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

Study Contact

Study Locations

  • South Korea
      • Daegu, South Korea, 41404
        • Kyungpook National University Chilgok Hospital
        • Principal Investigator:
          • Joonho Moon, MD-PhD
      • Goyang-si, South Korea, 10408
        • National Cancer Center Korea
        • Principal Investigator:
          • Hyeon Jin Park, MD-PhD
      • Hwasun, South Korea, 58128
        • Chonnam National University Hwasun Hospital
        • Principal Investigator:
          • Hoon Kook, MD-PhD
      • Seoul, South Korea, 07804
        • Ewha Womans University Seoul Hospital
        • Principal Investigator:
          • Eun Sun Yoo, MD-PhD
      • Ulsan, South Korea, 44033
        • Ulsan University Hospital
        • Principal Investigator:
          • Jae-Cheol Jo, MD-PhD
    • Seoul
      • Seoul, Seoul, South Korea, 03080
        • Seoul National University Hospital
        • Principal Investigator:
          • Hyoung Jin Kang, MD-PhD
      • Seoul, Seoul, South Korea, 05505
        • Asan Medical Center
        • Principal Investigator:
          • Ho-joon Im, MD-PhD
      • Seoul, Seoul, South Korea, 03722
        • Severance Hospital
      • Seoul, Seoul, South Korea, 06351
        • Samsung Seoul Hospital
        • Principal Investigator:
          • Ye-jin Kim, MD-PhD

Participation Criteria

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

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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.

  2. 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
  3. Subjects confirmed by the investigator to be unresponsive to treatment despite at least 7 days of standard inpatient therapy.
  4. 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.
  5. Patients for whom at least 21 days (D+21) have elapsed since allogeneic hematopoietic stem cell transplantation as of the screening date.
  6. Patients who are able to reduce their steroid dosage to 0.5 mg/kg/day of prednisolone (or an equivalent dose) or less.
  7. For women of childbearing potential, those who tested negative on a pregnancy test (blood test) performed on the screening visit.

  8. 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)
  9. Individuals who have voluntarily decided to participate in this clinical trial and have provided written consent to comply with the restrictions.
  10. Individuals deemed suitable as trial subjects through screening tests (vital signs, physical examination, medical and surgical history, electrocardiogram, laboratory tests, etc.).

Exclusion Criteria:

  1. 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.
  2. Patients with hemorrhagic cystitis caused by adenovirus (excluded via urine PCR)
  3. Patients with bacterial growth in urine culture (excluded via bacterial culture)

  4. 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%
      • 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.
  5. 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.
  6. Active acute graft-versus-host disease (GvHD) of grade 3 or higher.
  7. Patients requiring urgent anticancer therapy due to rapid tumor progression.
  8. 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.
  9. Patients requiring vasopressors.
  10. Patients who have previously shown hypersensitivity to T-cell therapy.
  11. Patients with a history of autoimmune disease.
  12. Patients with hemophilia who are at risk of severe bleeding during administration, or patients receiving anticoagulants.
  13. Patients who have received another investigational drug within 24 weeks prior to administration of the investigational drug.
  14. Patients with a life expectancy of less than 24 hours at the time of the screening visit.
  15. Patients deemed ineligible for participation in this clinical trial by the investigator.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Group
Other: Standard-of-care
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.
Experimental: Experimental Group
Biological: LB-DTK-BKV
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.)
From enrollment through 24 weeks 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)
From enrollment through 24 weeks after treatment initiation.
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.
From enrollment through 24 weeks after treatment initiation.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BK virus viral load
Time Frame: From enrollment through 24 weeks after treatment initiation.
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.)
From enrollment through 24 weeks after treatment initiation.

Collaborators and Investigators

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

Sponsor

LucasBio

Investigators

  • Principal Investigator: Ye-jin Kim, MD-PhD, Department of Pediatrics, Samsung Seoul Hospital
  • Principal Investigator: Hyoung Jin Kang, MD-PhD, Department of Pediatric Hematology-Oncology, Seoul National University Hospital
  • Principal Investigator: Ho-joon Im, MD-PhD, Department of Pediatric Hematology & Oncology, Asan Medical Center
  • Principal Investigator: Hyeon Jin Park, MD-PhD, National Cancer Center, Korea
  • Principal Investigator: Seung Min Hahn, MD-PhD, Department of Pediatric Hematology & Oncology, Severance Hospital
  • Principal Investigator: Hoon Kook, MD-PhD, Department of Pediatric Hematology & Oncology, Chonnam National University Hwasun Hospital
  • Principal Investigator: Jae-Cheol Jo, MD-PhD, Department of Hematology, Ulsan University Hospital
  • Principal Investigator: Eun Sun Yoo, MD-PhD, Department of Pediatric Hematology Oncology, Ewha Womans University Seoul Hospital
  • Principal Investigator: Joonho Moon, MD-PhD, Department of Hematology-Oncology, Kyungpook National University Chilgok Hospital

Publications and helpful links

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

General Publications

Study record dates

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

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

June 5, 2026

First Submitted That Met QC Criteria

June 5, 2026

First Posted (Actual)

June 10, 2026

Study Record Updates

Last Update Posted (Actual)

June 10, 2026

Last Update Submitted That Met QC Criteria

June 5, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LB-DTK-BKV-DD-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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

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