Evaluation of the Safety and Efficacy of LB-DTK-BKV in Patients With BK Virus-Associated Hemorrhagic Cystitis Following Allogeneic Hematopoietic Stem Cell Transplantation

Summary

The goal of this clinical trial is to assess efficacy of BK virus specific T cells (LB-DTK-BKV) to treat pediatric, adolescent, and adult patients with BK virus-associated hemorrhagic cystitis after allogenic hematopoietic stem cell transplantation (allo-HSCT). It will also evaluate the safety of LB-DTK-BKV using treatment-emergent adverse events (TEAEs). The main questions it aims to answer are:

* Does LB-DTK-BKV reduce the number of BKV virus viral load in allo-HSCT patients with hemorrhagic cystitis?
* Do adverse events occur after the second dose? Researchers will compare LB-DTK-BKV to a placebo to see if LB-DTK-BKV works to treat hemorrhagic cystitis in allo-HSCT patients.

Participants will:

* Receive a single intravenous infusion of LB-DTK-BKV at the baseline visit (low dose: 1x10\^7/m\^2; high dose: 2x10\^7/m\^2).
* Receive the second dose of LB-DTK-BKV intravenously at the same dose 14 days after the first dose.
* Visit the clinic every week for follow-up for 6 months after the first dose.

Conditions

• Hemorrhagic Cystitis

Interventions

BIOLOGICAL

LB-DTK-BKV

LB-DTK-BKV derived from a designated donor determined based on the type of allogeneic hematopoietic stem cell transplant the subject is undergoing. A pale yellow cell suspension filled in a colorless, transparent freeze-dried vial that 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) on Visit 2 and 14 days after the initial dose.

OTHER

Standard-of-care

Standard-of-care therapy for BK virus-associated hemorrhagic cystitis after allogeneic hematopoietic stem cell transplantation will be administered according to the participant's clinical status by the principal investigator. Participants in the placebo group will not receive LB-DTK-BKV during the clinical trial.

Sponsors & Collaborators

• LucasBio

  lead INDUSTRY

Principal Investigators

• Yae-Jean Kim, MD-PhD · Department of Pediatrics, Samsung Medical Center

• Hyoung Jin Kang, MD-PhD · Department of Pediatric Hematology-Oncology, Seoul National University Hospital

• Ho-joon Im, MD-PhD · Department of Pediatric Hematology & Oncology, Asan Medical Center

• Hyeon Jin Park, MD-PhD · National Cancer Center, Korea

• Seung Min Hahn, MD-PhD · Department of Pediatric Hematology & Oncology, Severance Hospital

• Hoon Kook, MD-PhD · Department of Pediatric Hematology & Oncology, Chonnam National University Hwasun Hospital

• Jae-Cheol Jo, MD-PhD · Department of Hematology, Ulsan University Hospital

• Eun Sun Yoo, MD-PhD · Department of Pediatric Hematology Oncology, Ewha Womans University Seoul Hospital

• Joonho Moon, MD-PhD · Department of Hematology-Oncology, Kyungpook National University Chilgok Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2028-03-01

Completion

2028-03-01

Countries

• South Korea

Study Locations