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 de julho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
42
Estágio
- Fase 2
- Fase 1
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Nayoun Kim, Ph.D.
- Número de telefone: +82 1040222340
- E-mail: nkim@lucasbio.com
Locais de estudo
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Daegu, Coréia do Sul, 41404
- Kyungpook National University Chilgok Hospital
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Investigador principal:
- Joonho Moon, MD-PhD
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Goyang-si, Coréia do Sul, 10408
- National Cancer Center Korea
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Investigador principal:
- Hyeon Jin Park, MD-PhD
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Hwasun, Coréia do Sul, 58128
- Chonnam National University Hwasun Hospital
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Investigador principal:
- Hoon Kook, MD-PhD
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Seoul, Coréia do Sul, 07804
- Ewha Womans University Seoul Hospital
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Investigador principal:
- Eun Sun Yoo, MD-PhD
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Ulsan, Coréia do Sul, 44033
- Ulsan University Hospital
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Investigador principal:
- Jae-Cheol Jo, MD-PhD
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Seoul
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Seoul, Seoul, Coréia do Sul, 03080
- Seoul National University Hospital
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Investigador principal:
- Hyoung Jin Kang, MD-PhD
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Seoul, Seoul, Coréia do Sul, 05505
- Asan Medical Center
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Investigador principal:
- Ho-joon Im, MD-PhD
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Seoul, Seoul, Coréia do Sul, 06351
- Samsung Medical Center
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Investigador principal:
- Yae-Jean Kim, MD-PhD
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Seoul, Seoul, Coréia do Sul, 03722
- Severance Hospital
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- 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:
- 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)
- Individuals who have voluntarily decided to participate in this clinical trial and have provided written consent to comply with the restrictions.
- Individuals deemed suitable as trial subjects through screening tests (vital signs, physical examination, medical and surgical history, electrocardiogram, laboratory tests, etc.).
Exclusion Criteria:
- 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 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.
- 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.
- Active acute graft-versus-host disease (GvHD) of grade 3 or higher.
- Patients requiring urgent anticancer therapy due to rapid tumor progression.
- 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.
- Patients requiring vasopressors.
- Patients who have previously shown hypersensitivity to T-cell therapy.
- Patients with a history of autoimmune disease.
- Patients with hemophilia who are at risk of severe bleeding during administration, or patients receiving anticoagulants.
- Patients who have received another investigational drug within 24 weeks prior to administration of the investigational drug.
- Patients with a life expectancy of less than 24 hours at the time of the screening visit.
- Patients deemed ineligible for participation in this clinical trial by the investigator.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador de Placebo: Grupo Placebo
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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.
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Experimental: Grupo experimental
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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BK virus viral load
Prazo: From enrollment through 24 weeks after treatment initiation.
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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.)
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From enrollment through 24 weeks after treatment initiation.
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Immunogenicity Testing
Prazo: From enrollment through 24 weeks after treatment initiation.
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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)
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From enrollment through 24 weeks after treatment initiation.
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Adverse Events
Prazo: From enrollment through 24 weeks after treatment initiation.
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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.
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From enrollment through 24 weeks after treatment initiation.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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BK virus viral load
Prazo: From enrollment through 24 weeks after treatment initiation.
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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.)
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From enrollment through 24 weeks after treatment initiation.
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Hyoung Jin Kang, MD-PhD, Department of Pediatric Hematology-Oncology, Seoul National University Hospital
- Investigador principal: Ho-joon Im, MD-PhD, Department of Pediatric Hematology & Oncology, Asan Medical Center
- Investigador principal: Hyeon Jin Park, MD-PhD, National Cancer Center, Korea
- Investigador principal: Seung Min Hahn, MD-PhD, Department of Pediatric Hematology & Oncology, Severance Hospital
- Investigador principal: Hoon Kook, MD-PhD, Department of Pediatric Hematology & Oncology, Chonnam National University Hwasun Hospital
- Investigador principal: Jae-Cheol Jo, MD-PhD, Department of Hematology, Ulsan University Hospital
- Investigador principal: Eun Sun Yoo, MD-PhD, Department of Pediatric Hematology Oncology, Ewha Womans University Seoul Hospital
- Investigador principal: Joonho Moon, MD-PhD, Department of Hematology-Oncology, Kyungpook National University Chilgok Hospital
- Investigador principal: Yae-Jean Kim, MD-PhD, Department of Pediatrics, Samsung Medical Center
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
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- Berger M, Lanino E, Cesaro S, Zecca M, Vassallo E, Faraci M, De Bortoli M, Barat V, Prete A, Fagioli F. Feasibility and Outcome of Haploidentical Hematopoietic Stem Cell Transplantation with Post-Transplant High-Dose Cyclophosphamide for Children and Adolescents with Hematologic Malignancies: An AIEOP-GITMO Retrospective Multicenter Study. Biol Blood Marrow Transplant. 2016 May;22(5):902-9. doi: 10.1016/j.bbmt.2016.02.002. Epub 2016 Feb 6.
- Vasileiou S, Turney AM, Kuvalekar M, Mukhi SS, Watanabe A, Lulla P, Ramos CA, Naik S, Vera JF, Tzannou I, Leen AM. Rapid generation of multivirus-specific T lymphocytes for the prevention and treatment of respiratory viral infections. Haematologica. 2020 Jan;105(1):235-243. doi: 10.3324/haematol.2018.206896. Epub 2019 Apr 19. No abstract available.
- Mackall CL, Fleisher TA, Brown MR, Magrath IT, Shad AT, Horowitz ME, Wexler LH, Adde MA, McClure LL, Gress RE. Lymphocyte depletion during treatment with intensive chemotherapy for cancer. Blood. 1994 Oct 1;84(7):2221-8.
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- Hunger SP, Mullighan CG. Acute Lymphoblastic Leukemia in Children. N Engl J Med. 2015 Oct 15;373(16):1541-52. doi: 10.1056/NEJMra1400972. No abstract available.
- Jahangiri, V., et al., Post-Transplantation Cyclophosphamide (PTCY) Is Associated with Increased Risk of BK Virus-Associated Hemorrhagic Cystitis (BKHC) in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant (HSCT). Biology of Blood and Marrow Transplantation, 2019.25 (3): p. S359-S360.
- Cho SG, Kim N, Sohn HJ, Lee SK, Oh ST, Lee HJ, Cho HI, Yim HW, Jung SE, Park G, Oh JH, Choi BO, Kim SW, Kim SW, Chung NG, Lee JW, Hong YS, Kim TG. Long-term Outcome of Extranodal NK/T Cell Lymphoma Patients Treated With Postremission Therapy Using EBV LMP1 and LMP2a-specific CTLs. Mol Ther. 2015 Aug;23(8):1401-1409. doi: 10.1038/mt.2015.91. Epub 2015 May 28.
- Simmons HZ, Bazzell AF, Dains JE. Adverse Effects of Virus-Specific T-Cell Therapy: An Integrative Review. J Adv Pract Oncol. 2019 Mar;10(2):120-131. Epub 2019 Mar 1.
- Cruz CR, Hanley PJ, Liu H, Torrano V, Lin YF, Arce JA, Gottschalk S, Savoldo B, Dotti G, Louis CU, Leen AM, Gee AP, Rooney CM, Brenner MK, Bollard CM, Heslop HE. Adverse events following infusion of T cells for adoptive immunotherapy: a 10-year experience. Cytotherapy. 2010 Oct;12(6):743-9. doi: 10.3109/14653241003709686.
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- Vasileiou S, Hill L, Kuvalekar M, Workineh AG, Watanabe A, Velazquez Y, Lulla S, Mooney K, Lapteva N, Grilley BJ, Heslop HE, Rooney CM, Brenner MK, Eagar TN, Carrum G, Grimes KA, Leen AM, Lulla P. Allogeneic, off-the-shelf, SARS-CoV-2-specific T cells (ALVR109) for the treatment of COVID-19 in high-risk patients. Haematologica. 2023 Jul 1;108(7):1840-1850. doi: 10.3324/haematol.2022.281946.
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- Chandraker A, Regmi A, Gohh R, Sharma A, Woodle ES, Ansari MJ, Nair V, Chen LX, Alhamad T, Norman S, Cibrik D, Singh M, Alper A, Jain D, Zaky Z, Knechtle S, Sharfuddin A, Gupta G, Lonze BE, Young JH, Adey D, Faravardeh A, Dadhania DM, Rossi AP, Florescu D, Cardarelli F, Ma J, Gilmore S, Vasileiou S, Jindra PT, Wojciechowski D. Posoleucel in Kidney Transplant Recipients with BK Viremia: Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial. J Am Soc Nephrol. 2024 May 1;35(5):618-629. doi: 10.1681/ASN.0000000000000329. Epub 2024 Mar 12.
- Zhou X, Zhang S, Fan J, Zhu X, Hu S. Risk factors for BK virus-associated hemorrhagic cystitis after allogeneic hematopoietic stem cell transplantation: A systematic review and meta-analysis. Clin Transplant. 2023 Nov;37(11):e15121. doi: 10.1111/ctr.15121. Epub 2023 Sep 7.
- Cesaro S, Dalianis T, Hanssen Rinaldo C, Koskenvuo M, Pegoraro A, Einsele H, Cordonnier C, Hirsch HH; ECIL-6 Group. ECIL guidelines for the prevention, diagnosis and treatment of BK polyomavirus-associated haemorrhagic cystitis in haematopoietic stem cell transplant recipients. J Antimicrob Chemother. 2018 Jan 1;73(1):12-21. doi: 10.1093/jac/dkx324.
- van den Brink MR, Velardi E, Perales MA. Immune reconstitution following stem cell transplantation. Hematology Am Soc Hematol Educ Program. 2015;2015:215-9. doi: 10.1182/asheducation-2015.1.215. No abstract available.
- Khan MA, Bashir Q, Chaudhry QU, Ahmed P, Satti TM, Mahmood SK. Review of Haploidentical Hematopoietic Cell Transplantation. J Glob Oncol. 2018 Dec;4:1-13. doi: 10.1200/JGO.18.00130.
- Pulsipher MA, Peters C, Pui CH. High-risk pediatric acute lymphoblastic leukemia: to transplant or not to transplant? Biol Blood Marrow Transplant. 2011 Jan;17(1 Suppl):S137-48. doi: 10.1016/j.bbmt.2010.10.005.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de setembro de 2026
Conclusão Primária (Estimado)
1 de março de 2028
Conclusão do estudo (Estimado)
1 de março de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
5 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
5 de junho de 2026
Primeira postagem (Real)
10 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
24 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
22 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças urogenitais
- Doenças Urogenitais Masculinas
- Doenças Urológicas
- Doenças Urogenitais Femininas
- Doenças urogenitais femininas e complicações na gravidez
- Doenças da Bexiga Urinária
- Cistite Hemorrágica
- Infecções
- Doenças Virais
- Cistite
- Administração de Serviços de Saúde
- Qualidade, acesso e avaliação da assistência médica
- Qualidade de assistência médica
- Indicadores de qualidade, assistência médica
- Padrão de atendimento
Outros números de identificação do estudo
- LB-DTK-BKV-DD-001
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .