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

NCT07638332 | Not Yet Recruiting Phase 1

• 1 other identifier: LB-DTK-BKV-DD-001
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 9

Brief 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). 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.

Conditions

Hemorrhagic Cystitis

Keywords

BK-Virus; Hemorrhagic Cystitis; Virus-specific T cells; Allogeneic Hematopoietic Stem Cell Transplantation; Stem Cell Transplant; Virus Diseases; Infections; Cystitis

Outcome Measures

Primary Outcomes (3)

• 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.)

  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)

  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.

  From enrollment through 24 weeks after treatment initiation.

Secondary Outcomes (1)

• BK virus viral load

  From enrollment through 24 weeks after treatment initiation.

Study Arms (2)

Experimental Group

EXPERIMENTAL

Biological: LB-DTK-BKV

Placebo Group

PLACEBO COMPARATOR

Other: Standard-of-care

Interventions

LB-DTK-BKV BIOLOGICAL

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.

Experimental Group

Standard-of-care OTHER

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.

Placebo Group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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:

You may not qualify if:

• 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.
• 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 C Virus (HCV) infection
• Tuberculosis
• Syphilis
• Moderate or severe liver damage \[Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \> 5 times the upper limit of normal (ULN)\]

Sponsors & Collaborators

• LucasBio: lead

Study Sites (9)

Seoul National University Hospital

Seoul, Seoul, 03080, South Korea

Location

Severance Hospital

Seoul, Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, Seoul, 06351, South Korea

Location

Kyungpook National University Chilgok Hospital

Daegu, 41404, South Korea

Location

National Cancer Center Korea

Goyang-si, 10408, South Korea

Location

Chonnam National University Hwasun Hospital

Hwasun, 58128, South Korea

Location

Ewha Womans University Seoul Hospital

Seoul, 07804, South Korea

Location

Ulsan University Hospital

Ulsan, 44033, South Korea

Location

Related Publications (25)

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MeSH Terms

Conditions

Cystitis, Hemorrhagic; Virus Diseases; Infections; Cystitis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Yae-Jean Kim, MD-PhD

  Department of Pediatrics, Samsung Medical Center

  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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nayoun Kim, Ph.D.

CONTACT

+82 1040222340; nkim@lucasbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 10, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: July 24, 2026

Record last verified: 2026-07

Locations

KR (9)