Virus-specific T cells for kids after stem cell transplant

Is this trial a fit for you?

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 in pediatric patients evaluates the safety and potential efficacy of LB-DTK-MV, multi-virus specific T cells, given by intravenous infusion after allogeneic hematopoietic stem cell transplantation. Participants receive two infusions, at baseline and 14 days later, at one of two dose levels, to determine maximum tolerated dose and monitor adverse events within 14 days after the second infusion. The study aims to see if viral loads and clinical symptoms improve within 14 days post-infusion. Eligibility includes pediatric patients aged 1–25 with CMV, EBV, or BKV infections resistant to standard therapy, adequate neutrophil engraftment, donor chimerism, and ability to reduce steroids.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Catholic University of Korea Seoul St.Mary's Hospital
  Seoul, South Korea Recruiting

Study contacts

• Principal investigator: Jae-won Yoo, MD-PhD — Department of Pediatrics, 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.

• Multi-Virus Specific T cells for antiviral-resistant CMV, BKV, or EBV after cancer therapy or stem cell transplant

  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.

  Recruiting Phase 1/2 LucasBio · Seoul · NCT07670468

• T-cell therapy for viral infections after stem cell transplant

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• AIC263029 in kidney transplant recipients with BK virus infection

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• Valacyclovir versus valganciclovir to prevent CMV and EBV after kidney transplant

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• Artesunate combined with standard antiviral therapy for CMV in organ transplant recipients.

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• Using EBV-TCR-T cells to treat EBV-related conditions

  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.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.