Donor cells take on Drug-Resistant viruses in new trial
NCT ID NCT07670468
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests a treatment called LB-DTK-MV, which uses immune cells from a healthy donor to fight three viruses (CMV, BKV, and EBV) that have become resistant to standard antiviral drugs. The study includes 27 adults who have had a stem cell transplant or certain cancer therapies. Participants receive two infusions of these donor cells, and researchers will monitor safety, side effects, and whether the viral levels drop.
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 (donor immune cells targeting multiple viruses)
- What this could lead to
- If successful, this could offer a new treatment option for patients with dangerous viral infections that do not respond to standard antiviral drugs after cancer therapy or stem cell transplant.
- What could go wrong
- This is an early-phase trial with only 27 participants, so results may not apply to everyone. There is a risk of side effects, and the treatment may not effectively clear the viruses.
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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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 27 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Jun 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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19 years and older
- 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 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: * CAR-T: Kymriah, Yescarta * Bispecific Antibody: Glofitamab, Mosunetuzumab, Teclistamab, Elranatamab, etc 2. Patients diagnosed with single or multiple, antiviral-resistant CMV, BKV, and/or EBV despite receiving standard treatment. 3. Patients who are able to reduce their steroid dosage to 0.5mg/kg/day of Prednisolone (or an equivalent dose) or less. 4. Patients with a hemoglobin level ≥8.0g/dL. 5. 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. 6. Patients with peripheral oxygen saturation (SpO2) ≥90% on room air. 7. Patients who have at least one MHC class I HLA allele that matches the investigational product. 8. For women of childbearing potential, those who tested negative on a pregnancy test (blood test) performed on the screening visit. 9. 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) 10. Individuals who have voluntarily decided to participate in this clinical trial and have provided written consent to comply with the restrictions. 11. 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. 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. * Other viral infections \[Ex. Human Immunodeficiency Virus(HIV), Hepatitis B Virus(HBV), Hepatitis C Virus(HCV)\]. However, patients who are tested negative for HBsAg and positive for anti-HBcAb are not subject to this exclusion criterion. * Tuberculosis * Syphilis * 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 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. 3. 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. 4. Patients with active acute graft-versus-host disease (GvHD) of grade 2 or higher. 5. Patients requiring urgent anticancer therapy due to rapid tumor progression. 6. 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. 7. Patients requiring vasopressors. 8. Patients who have previously shown hypersensitivity to T-cell therapy. 9. Patients with a history of autoimmune disease. 10. Patients with hemophilia who are at risk of severe bleeding during administration, or patients receiving anticoagulants. 11. Patients who have received another virus-specific T cell product within 28 days prior to administration of the investigational drug. 12. Patients with a life expectancy of less than 24 hours at the time of the screening visit. 13. Patients aged under 19. 14. Patients deemed ineligible for participation in this clinical trial 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.
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- Immune cells engineered to hunt viruses show promise for transplant kids
- Supercharged immune cells take on Drug-Resistant infections
- 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