BridgeMD
Tests treatment safety and results for BKV Infection
Official title Evaluation of Safety and Efficacy of Virus Specific T-Cell Administration in Pediatric Patients With Systemic Viral Infection Following Allogeneic Hematopoietic Stem Cell Transplantation.
ClinicalTrials.gov ID: NCT07685457
What this study is testing
What is LB-DTK-MV?
LB-DTK-MV is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for bkv infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this prospective clinical study is to evaluate the safety and efficacy of Multi-Virus Specific T cells (LB-DTK-MV) in pediatric patients with systemic viral infection, including CMV, EBV, and BKV, after allogeneic hematopoietic stem cell transplantation (allo-HSCT). The main questions it aims to answer are: What is the maximum tolerated dose of LB-DTK-MV based on dose-limiting toxicity?
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 25
You may be able to join if
- Patients with CMV, EBV, and/or BKV infection that is resistant or refractory to standard-of-care treatment and associated with severe complications...
- Patients with evidence of neutrophil engraftment, defined as an absolute neutrophil count (ANC) maintained at 0.5x10\^3/μL or higher for 3...
- Patients who have undergone allogeneic hematopoietic stem cell transplantation at least 21 days prior to the screening visit.
- Patients who show complete donor chimerism (PCR-short tandem repeats ≥ 95%) at the time of first dose administration.
- Patients who are able to reduce their steroid dosage to 0.5mg/kg/day of Prednisolone (or an equivalent dose) or less.
You likely can't join if
- Individuals who have received treatment with ATG (Antithymocyte Globulin), Campath (Alemtuzumab), or other T-cell immunosuppressive monoclonal...
- Patients with organ failures and/or uncontrolled bacterial or fungal infections.
- Moderate or severe liver damage [Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \> 5 times the upper limit of normal (ULN)]
- Chronic kidney disease [eGFR \< 30mL/min/1.73m\^2]
- Patients who have undergone allogeneic hematopoietic stem cell transplantation or received donor lymphocyte infusion (DLI) within 28 days prior to...
- Patients with active graft-versus-host disease (GvHD) of grade 2 or higher.
See the full eligibility criteria
- Patients with CMV, EBV, and/or BKV infection that is resistant or refractory to standard-of-care treatment and associated with severe complications following allogeneic hematopoietic stem cell transplantation at the...
- Patients with evidence of neutrophil engraftment, defined as an absolute neutrophil count (ANC) maintained at 0.5x10\^3/μL or higher for 3 consecutive days following allogeneic hematopoietic stem cell transplantation.
- Patients who have undergone allogeneic hematopoietic stem cell transplantation at least 21 days prior to the screening visit.
- Patients who show complete donor chimerism (PCR-short tandem repeats ≥ 95%) at the time of first dose administration.
- Patients who are able to reduce their steroid dosage to 0.5mg/kg/day of Prednisolone (or an equivalent dose) or less.
- Individuals who have voluntarily decided to participate in this clinical study and have provided written consent to comply with the restrictions.
- For women of childbearing potential, those who tested negative on a pregnancy test (blood test) performed on the screening visit.
- Individuals deemed suitable as study people through screening tests (vital signs, physical examination, medical and surgical history, electrocardiogram, laboratory tests, etc.).
- 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 organ failures and/or uncontrolled bacterial or fungal infections.
- Moderate or severe liver damage [Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \> 5 times the upper limit of normal (ULN)]
- Chronic kidney disease [eGFR \< 30mL/min/1.73m\^2]
- Patients who have undergone allogeneic hematopoietic stem cell transplantation or received donor lymphocyte infusion (DLI) within 28 days prior to the scheduled first dose.
- Patients with active graft-versus-host disease (GvHD) of grade 2 or higher.
- Patients with active malignant tumor or uncontrolled recurrence.
- Patients deemed ineligible for participation in this clinical study by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.