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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.

5. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

42

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo gruppe
Andet: 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.
Eksperimentel: Forsøgsgruppe
Biologisk: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
BK virus viral load
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
BK virus viral load
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

LucasBio

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. marts 2028

Studieafslutning (Anslået)

1. marts 2028

Datoer for studieregistrering

Først indsendt

5. juni 2026

Først indsendt, der opfyldte QC-kriterier

5. juni 2026

Først opslået (Faktiske)

10. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • LB-DTK-BKV-DD-001

Plan for individuelle deltagerdata (IPD)

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