Evaluation of the Safety and Efficacy of LB-DTK-MV in Patients Diagnosed With Antiviral-Resistant… (NCT07670468) | Clinical Trial Compass
RecruitingPhase 1/2
Evaluation of the Safety and Efficacy of LB-DTK-MV in Patients Diagnosed With Antiviral-Resistant CMV, BKV, or EBV Infection or Associated Diseases Following Anticancer Therapy or Allogeneic Hematopoietic Stem Cell Transplantation.
South Korea27 participantsStarted 2025-12-04
Plain-language summary
The goal of this clinical trial is to evaluate the efficacy and safety of Multi-Virus Specific T cells (LB-DTK-MV) to treat patients diagnosed with antiviral-resistant CMV, BKV, or EBV infection or associated diseases after anticancer therapy or 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?
* Does the number of CMV, BKV, or EBV virus viral load decrease within 7 or 14 days after the second infusion of LB-DTK-MV?
* Do treatment emergent adverse events occur after the second infusion?
Participants will:
* Receive a single intravenous infusion of LB-DTK-MV during the baseline visit (low dose: 1x10\^7/m\^2; high dose: 2x10\^7/m\^2).
* Receive the second infusion of LB-DTK-MV intravenously at the same dose 14 days after the first infusion.
* Attend weekly follow-up visits at the clinic for 6 months after the first dose.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients aged 19 years or older who have undergone myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplantation using bone marrow, single or double umbilical cord blood, or peripheral blood stem cells (PBSCs). Or patients who have undergone any of the following anticancer treatments:
. Patients diagnosed with single or multiple, antiviral-resistant CMV, BKV, and/or EBV despite receiving standard treatment.
. Patients who are able to reduce their steroid dosage to 0.5mg/kg/day of Prednisolone (or an equivalent dose) or less.
. Patients with a hemoglobin level ≥8.0g/dL.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
CMV viral load
Timeframe: From enrollment through 24 weeks after treatment initiation
2
BKV viral load
Timeframe: From enrollment through 24 weeks after treatment initiation.
3
EBV viral load
Timeframe: From enrollment through 24 weeks after treatment initiation.
4
Immunogenicity Testing
Timeframe: From enrollment through 24 weeks after treatment initiation.
5
Adverse Events
Timeframe: From the baseline visit through 24 weeks after treatment initiation.
. Patients with peripheral oxygen saturation (SpO2) ≥90% on room air.
. Patients who have at least one MHC class I HLA allele that matches the investigational product.
. For women of childbearing potential, those who tested negative on a pregnancy test (blood test) performed on the screening visit.
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.
. Individuals who meet any of the following criteria at the time of screening:
. 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.
. Patients with active acute graft-versus-host disease (GvHD) of grade 2 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.