Immune cells engineered to hunt viruses show promise for transplant kids
NCT ID NCT07685457
First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time
Summary
This study tests a new cell therapy called LB-DTK-MV in children aged 1-25 who have stubborn viral infections (CMV, EBV, or BKV) after a stem cell transplant. The therapy uses specially grown immune cells from a donor to attack the viruses. Participants receive two infusions two weeks apart and are monitored for side effects, viral levels, and symptom improvement over six months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LB-DTK-MV (virus-specific T cells)
- What this could lead to
- If successful, this could offer a new treatment option for children with stubborn viral infections after a stem cell transplant, potentially reducing the need for other antiviral drugs.
- What could go wrong
- This is a very small, early-stage trial with only 6 participants, so results may not apply to everyone. The therapy may cause side effects or fail to control the infection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 6 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 year to 25 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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 ages of 1-25 years. 2. 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. 3. Patients who have undergone allogeneic hematopoietic stem cell transplantation at least 21 days prior to the screening visit. 4. Patients who show complete donor chimerism (PCR-short tandem repeats ≥ 95%) at the time of first dose administration. 5. Patients who are able to reduce their steroid dosage to 0.5mg/kg/day of Prednisolone (or an equivalent dose) or less. 6. Individuals who have voluntarily decided to participate in this clinical study and have provided written consent to comply with the restrictions. 7. For women of childbearing potential, those who tested negative on a pregnancy test (blood test) performed on the screening visit. 8. Individuals deemed suitable as study 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 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 \[eGFR \< 30mL/min/1.73m\^2\] 3. Patients who have undergone allogeneic hematopoietic stem cell transplantation or received donor lymphocyte infusion (DLI) within 28 days prior to the scheduled first dose. 4. Patients with active graft-versus-host disease (GvHD) of grade 2 or higher. 5. Patients with active malignant tumor or uncontrolled recurrence. 6. Patients deemed ineligible for participation in this clinical study by the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Catholic University of Korea Seoul St.Mary's Hospital
RECRUITINGSeoul, 06591, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A new attack on Epstein-Barr fatigue: two capsules put to the test
- Supercharged immune cells take on Drug-Resistant infections
- Donor cells take on Drug-Resistant viruses in new trial
- New drug may offer safer CMV prevention for kidney transplant patients
- New immune duo shows promise in preventing Post-Transplant infection
- Transplant drug tweak may tame common virus