Evaluation of Safety and Efficacy of Virus Specific T-Cell Administration in Pediatric Patients With Systemic Viral Infection Following Allogeneic Hematopoietic Stem Cell Transplantation.
2026年6月29日 更新者：JaeWon Yoo、LucasBio
A Prospective Clinical Study to Evaluate the Safety and Efficacy of Virus Specific T-Cell Administration in Pediatric Patients With Systemic Viral Infection Following Allogeneic Hematopoietic Stem Cell Transplantation.
The goal of this prospective clinical study is to evaluate the safety and efficacy of Multi-Virus Specific T cells (LB-DTK-MV) in pediatric patients with systemic viral infection, including CMV, EBV, and BKV, after 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?
- What treatment emergent adverse events occur within 14 days after the second infusion?
- Is there a clinically significant reduction in CMV, EBV, and BKV viral loads within 14 days following the second infusion?
- Is there a clinically significant improvement in clinical symptoms within 14 days following 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 infusion.
調査の概要
研究の種類
介入
入学 (推定)
6
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Nayoun Kim, Ph.D.
- 電話番号：+82 1040222340
- メール：nkim@lucasbio.com
研究場所
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Seoul、韓国、06591
- 募集
- The Catholic University of Korea Seoul ST.MARY'S Hospital
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主任研究者：
- Jae-won Yoo, MD-PhD
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- 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.
- 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.
- Patients who have undergone allogeneic hematopoietic stem cell transplantation at least 21 days prior to the screening visit.
- Patients who show complete donor chimerism (PCR-short tandem repeats ≥ 95%) at the time of first dose administration.
- Patients who are able to reduce their steroid dosage to 0.5mg/kg/day of Prednisolone (or an equivalent dose) or less.
- Individuals who have voluntarily decided to participate in this clinical study and have provided written consent to comply with the restrictions.
- For women of childbearing potential, those who tested negative on a pregnancy test (blood test) performed on the screening visit.
- Individuals deemed suitable as study subjects through screening tests (vital signs, physical examination, medical and surgical history, electrocardiogram, laboratory tests, etc.).
Exclusion Criteria:
- 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.
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]
- Patients who have undergone allogeneic hematopoietic stem cell transplantation or received donor lymphocyte infusion (DLI) within 28 days prior to the scheduled first dose.
- Patients with active graft-versus-host disease (GvHD) of grade 2 or higher.
- Patients with active malignant tumor or uncontrolled recurrence.
- Patients deemed ineligible for participation in this clinical study by the investigator.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Experimental Group (All, ped)
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LB-DTK-MV is a virus-specific T cell therapy product derived from a designated donor and is stored frozen in a colorless, transparent freeze-dried vial 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 infusion.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Viral Load
時間枠：From enrollment through 24 weeks after treatment initiation
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CMV, EBV, and BKV viral load testing is performed using RT-PCR on blood, urine, and/or tissue samples.
Viral load is measured weekly for the first 4 weeks, followed by two measurements at 2-week intervals to monitor the progression of the infection, then once every 4 weeks, and subsequently once every 12 weeks.
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From enrollment through 24 weeks after treatment initiation
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Immunogenicity Testing
時間枠：From enrollment through 24 weeks after treatment initiation.
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Immunogenicity testing using the ELISpot assay is performed weekly for the first 4 weeks following administration of the investigational drug.
Thereafter, to evaluate the persistence and reconstitution of the immune response, measurements are taken twice at 2-week intervals, once at 4-week intervals, and once at 12-week intervals.
Flow cytometry will be performed concurrently at each time point to evaluate cytokine profiles and immune cell subsets.
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From enrollment through 24 weeks after treatment initiation.
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Adverse Events
時間枠：From the baseline visit through 24 weeks after treatment initiation.
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The investigator must confirm the occurrence of adverse events through medical examinations during regular visits throughout the clinical study period.
Adverse events shall be assessed at each visit starting from the administration of the investigational drug at the baseline visit (Visit 2).
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From the baseline visit through 24 weeks after treatment initiation.
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Jae-won Yoo, MD-PhD、Department of Pediatrics, The Catholic University of Korea Seoul St.Mary's Hospital
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年2月10日
一次修了 (推定)
2027年5月20日
研究の完了 (推定)
2027年5月20日
試験登録日
最初に提出
2026年6月29日
QC基準を満たした最初の提出物
2026年6月29日
最初の投稿 (実際)
2026年7月6日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月6日
QC基準を満たした最後の更新が送信されました
2026年6月29日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- LB-DD-DTK-MV-HS-PD-CR
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
未定
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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