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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.

NCT07670468 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2026-06-26

No results posted yet for this study

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.

Conditions

  • BKV Infection
  • EBV Infection
  • CMV Infection

Interventions

BIOLOGICAL

LB-DTK-MV

LB-DTK-MV is an allogeneic cell therapy product derived from a third-party donor and is supplied as a pale-yellow cell suspension at a final concentration of 4x10\^7cells/2mL in a colorless, transparent freeze-dried vial. The product is stored frozen until thawed into liquid before administration. Study participants will receive a single intravenous infusion of the assigned cell dose (low dose: 1x10\^7/m\^2;high dose: 2x10\^7/m\^2) of LB-DTK-MV on Visit 2 and 14 days after the initial dose.

Sponsors & Collaborators

  • LucasBio

    lead INDUSTRY

Principal Investigators

  • Dong-Gun Lee, MD-PhD · Department of Infectious Disease, The Catholic University of Korea Seoul St.Mary's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-04
Primary Completion
2027-06-04
Completion
2027-06-04

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07670468 on ClinicalTrials.gov