Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

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 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

42

Fase

  • Fase 2
  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Nayoun Kim, Ph.D.
  • Numero di telefono: +82 1040222340
  • Email: nkim@lucasbio.com

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Gruppo placebo
Altro: 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.
Sperimentale: Gruppo sperimentale
Biologico: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
BK virus viral load
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
BK virus viral load
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

LucasBio

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 marzo 2028

Completamento dello studio (Stimato)

1 marzo 2028

Date di iscrizione allo studio

Primo inviato

5 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

5 giugno 2026

Primo Inserito (Effettivo)

10 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • LB-DTK-BKV-DD-001

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su LB-DTK-BKV

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in France

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi