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

22 lipca 2026 zaktualizowane przez: 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 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

42

Faza

  • Faza 2
  • Faza 1

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Komparator placebo: Grupa placebo
Inny: 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.
Eksperymentalny: Grupa eksperymentalna
Biologiczny: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
BK virus viral load
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
BK virus viral load
Ramy czasowe: 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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

LucasBio

Śledczy

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

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 września 2026

Zakończenie podstawowe (Szacowany)

1 marca 2028

Ukończenie studiów (Szacowany)

1 marca 2028

Daty rejestracji na studia

Pierwszy przesłany

5 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

5 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

10 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

24 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

22 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • LB-DTK-BKV-DD-001

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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