Multi-Virus Specific T cells for antiviral-resistant CMV, BKV, or EBV after cancer therapy or stem cell transplant
Official title: A Single-Center, Open-Label, Phase 1/2 Clinical Trial to Evaluate 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.
Run by LucasBio · NCT07670468 · Data updated 2026-11-12
This trial tests LB-DTK-MV cells to see if they safely reduce CMV, BKV, or EBV in patients who have antiviral-resistant infections after cancer treatment or stem cell transplant.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 27 (estimated) |
| Sponsor | LucasBio Industry-sponsored |
| Drugs / interventions | Glofitamab, Mosunetuzumab, Teclistamab, Elranatamab, Alemtuzumab, CAR-T |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | December 4, 2025 |
| Main results expected | June 4, 2027 |
| Study ends | June 4, 2027 |
| Registry record updated | June 26, 2026 |
| Trial ID | NCT07670468 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (19+) who have undergone allogeneic HSCT or specific anticancer therapies and have antiviral-resistant CMV, BKV, and/or EBV infections despite standard treatment.
✕Probably not a fit
Patients without antiviral resistance or who do not tolerate LB-DTK-MV may not experience benefit and could have treatment-related adverse events.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study tests the safety and potential efficacy of LB-DTK-MV, a multi-virus specific T-cell therapy, in patients with antiviral-resistant CMV, BKV, or EBV infections or related diseases following anticancer therapy or allogeneic hematopoietic stem cell transplantation. Participants receive two intravenous infusions of LB-DTK-MV (low or high dose) 14 days apart, with weekly clinic follow-ups for six months. The study aims to determine the maximum tolerated dose, whether viral loads decrease within 7–14 days after the second infusion, and the occurrence of treatment-emergent adverse events. Eligible patients include adults post-HSCT or certain cancer therapies who have persistent, antiviral-resistant infections and meet immune-recovery criteria.
Why it matters
Potential benefit: If successful, patients may experience reduced viral loads and improved infection control after receiving LB-DTK-MV.
How similar studies have gone: Past studies with virus-specific T cells show promise in controlling viral infections after transplantation, but this exact multi-virus approach is being evaluated for safety and efficacy.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
The Catholic University of Korea Seoul St.Mary's Hospital
Seoul, South Korea Recruiting
Study contacts
- Principal investigator: Dong-Gun Lee, MD-PhD — Department of Infectious Disease, The Catholic University of Korea Seoul St.Mary's Hospital
- Study coordinator: Nayoun Kim, Ph.D.
- Email: nkim@lucasbio.com
- Phone: +82 1040222340
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Virus-specific T cells for kids after stem cell transplant
This trial tests whether giving virus-specific T cells can safely help children with CMV, EBV, or BKV infections after a stem cell transplant.
-
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This test checks whether valacyclovir works as well as valganciclovir to prevent CMV and EBV in people who recently had a kidney transplant.
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This trial will try adding IV artesunate to standard ganciclovir or oral valganciclovir in adult solid organ transplant patients with CMV to see if it improves viral clearance and safety.
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This study is testing a new treatment using special immune cells to see if it can help people with serious conditions related to the Epstein-Barr virus.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.