RecruitingPhase 1Phase 2NCT07670468

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.

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.


Sponsor

LucasBio

Enrollment

27 participants

Start Date

Dec 4, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called LB-DTK-MV for people with bkv infection, cmv infection, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALLB-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.


Locations(1)

The Catholic University of Korea Seoul St.Mary's Hospital

Seoul, South Korea

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NCT07670468


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