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Exploratory Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Tumor Neoantigen-pulsed Autologous Dendritic Cell Injection (YS247, Beijing YSCell Biotech Co., Ltd. [Abbreviated as YS])in Patients With Recurrent or Progressive Glioblastoma

2026年6月24日 更新者：Huanhu Hospital Affiliated to Tianjin Medical University

Exploratory Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Tumor Neoantigen-pulsed Autologous Dendritic Cell Injection (YS247) in Patients With Recurrent or Progressive Glioblastoma

This is a single-center, open-label, dose-escalation, multiple-dose investigator-initiated trial (IIT). The trial aims to evaluate the safety and tolerability of autologous dendritic cell injection sensitized with tumor neoantigens (YS247) in participants with recurrent or progressive glioblastoma, as well as to assess preliminary efficacy and pharmacodynamic characteristics. The study consists of four phases: screening, baseline, treatment, and follow-up. During the treatment phase, participants will be assigned to three dose groups (low, medium, and high) and enrolled following the "3+3" dose-escalation principle. YS247 will be administered subcutaneously once every 2 weeks for a total of 8 consecutive doses.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

A total of 9 to 18 participants are planned to be enrolled in this study. A dose-escalation design will be adopted following the 3+3 escalation principle, and the injection dose of the study drug YS247 is preset at three dose levels (low, medium, high) as specified below, with 3 to 6 participants planned to be enrolled in each dose level group. An adaptive trial design will be implemented, where the number of enrolled participants in each group will be adjusted based on the actual clinical study results

研究の種類

介入

入学 (推定)

9

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

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

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  1. Age 18-75 years (inclusive), any gender.
  2. Histologically confirmed GBM (WHO Grade IV).
  3. Recurrence/progression confirmed by MRI after standard therapy (surgery, Stupp protocol); ≥1 measurable lesion (max diameter ≥1.0 cm) on contrast-enhanced MRI per RANO criteria.
  4. KPS score ≥60, expected survival ≥6 months.
  5. ECOG score 0-2.
  6. Bridging therapy allowed during sample preparation; washout ≥7 days or 5 half-lives (whichever longer) before initial treatment.
  7. Radiotherapy completed ≥8 weeks before study drug initiation.
  8. Toxicity from prior anti-tumor therapy recovered to CTCAE V5.0 Grade 1 or below (except alopecia).

  9. Adequate organ function:

    • ANC ≥1.5×10⁹/L, ALC ≥0.8×10⁹/L, HGB ≥90 g/L, PLT ≥100×10⁹/L
    • AST/ALT ≤2.5×ULN, TBIL ≤2.5×ULN, ALB ≥3 g/dL, ALP ≤2.5×ULN
    • INR/APTT ≤1.5×ULN (except therapeutic anticoagulation)
    • Cr ≤1.5×ULN or CrCl ≥60 mL/min (Cockcroft-Gault)
    • Normal ECG, LVEF ≥50% (ECHO)
    • Resting SpO₂ >92% without oxygen
  10. Adequate venous access for PBMC collection, no contraindications.
  11. Sufficient tumor and blood samples for NGS via resection or biopsy.
  12. Negative serum pregnancy test (fertile females); effective contraception throughout screening, study, and 6 months after last dose for fertile participants/partners.
  13. Compliance with study procedures and follow-up.
  14. Voluntary participation and signed informed consent.

Exclusion Criteria:

  1. Any other active malignancy.
  2. Participation in another clinical trial within 4 weeks before enrollment.
  3. Prior gene transfer therapy.
  4. Concurrent anti-tumor therapy within 4 weeks before initial treatment (except allowed bridging); blood transfusion, EPO, G-CSF, or GM-CSF within 14 days before PBMC apheresis.
  5. Live virus/recombinant vaccine within 4 weeks before first treatment; expected need for live attenuated vaccine within 6 months after last dose.
  6. Severe allergy or hypersensitivity.
  7. MRI contrast contraindications (pacemaker, pump, contrast allergy).
  8. Positive HIV, HBV, HCV, or TP.
  9. Primary/secondary immunodeficiency or autoimmune disease (SLE, RA, IBD, autoimmune thyroid disease, autoimmune hepatitis, MS, vasculitis, glomerulonephritis, psoriasis, uncontrolled asthma).
  10. Severe infection within 1 month before treatment, uncontrolled infection, or antibiotics in the past week (except prophylaxis).
  11. Systemic immunosuppressive therapy within 30 days before initial treatment (short-term use allowed with sponsor approval; permitted: inhaled steroids, mineralocorticoids, low-dose steroids ≤10 mg/day prednisone equivalent).
  12. Uncontrolled systemic disease (NYHA III/IV heart failure, unstable angina, MI, cirrhosis, renal failure, severe lung disease, hematological/gastrointestinal/organ failure, diabetes, uncontrolled hypertension).
  13. ICD-11 psychiatric/neurological disorders (epilepsy, schizophrenia, dementia, addiction) per investigator judgment.
  14. Clinically significant bleeding within 3 months or bleeding diathesis; arterial/venous thromboembolism within 6 months (TIA, stroke, DVT, PE).
  15. Irreversible electrolyte imbalance.
  16. Anti-tumor therapy before apheresis: cytotoxic within 14 days; investigational within 28 days; immunomodulator within 7 days; targeted within 28 days.
  17. Pregnant or lactating female.
  18. Any other condition deemed unsuitable 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
実験的：Neoantigen DC Vaccine (YS247) for Glioblastoma
This is a single-center, open-label, dose-escalation, multiple-dose investigator-initiated trial (IIT). The trial aims to evaluate the safety and tolerability of autologous dendritic cell injection sensitized with tumor neoantigens (YS247) in participants with recurrent or progressive glioblastoma, as well as to assess preliminary efficacy and pharmacodynamic characteristics. The study consists of four phases: screening, baseline, treatment, and follow-up. During the treatment phase, participants will be assigned to three dose groups (low, medium, and high) and enrolled following the "3+3" dose-escalation principle. YS247 will be administered subcutaneously once every 2 weeks for a total of 8 consecutive doses.
生物学的：Neoantigen DC Vaccine (YS247) for Glioblastoma
Exploratory Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Tumor Neoantigen-pulsed Autologous Dendritic Cell Injection (YS247) in Patients with Recurrent or Progressive Glioblastoma

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
Safety and Treatment Tolerability
時間枠：From subject enrollment until completion of the 8th treatment cycle (each cycle is 14 days)
Evaluate the incidence of treatment-related adverse events (TRAEs) of Tumor Neoantigen-pulsed Autologous Dendritic Cell Injection (YS247, Beijing YSCell Biotech Co., Ltd., abbreviated as YS) in patients with recurrent or progressive glioblastoma based on CTCAE v5.0, to assess the safety and tolerability of the product.
From subject enrollment until completion of the 8th treatment cycle (each cycle is 14 days)
Maximum Tolerated Dose (MTD) and Recommended Expanded Dose(RP2D)
時間枠：From subject enrollment until completion of the 8th treatment cycle (each cycle is 14 days)

Based on the incidence of dose-limiting toxicities (DLTs), establish the MTD of Tumor Neoantigen-pulsed Autologous Dendritic Cell Injection (YS247) for patients with recurrent or progressive glioblastoma, and define the RP2D.

DLT is defined as any study drug-related AE (per CTCAE 5.0) or laboratory abnormality occurring from first dose to 4 weeks post-dose, unrelated to disease progression, comorbidity, or concomitant medication, including:

  1. CTCAE Grade 3 non-hematological toxicity lasting >7 days.
  2. Immune-related Grade 3 pneumonia, recurrent Grade 2 pneumonia.
  3. Other Grade 3 irAE not recovering to ≤Grade 2 in 3 days or ≤Grade 1 in 14 days with intervention.
  4. CTCAE Grade 4 non-hematological toxicity.
  5. CTCAE Grade 4 hematological toxicity lasting >7 days.
  6. CTCAE Grade 5 toxicity of any type.
  7. Any unexpected toxicity requiring treatment termination per investigator/sponsor judgment.
From subject enrollment until completion of the 8th treatment cycle (each cycle is 14 days)

二次結果の測定

結果測定
メジャーの説明
時間枠
Disease Control Rate (DCR)
時間枠：From subject enrollment until completion of the 8th treatment cycle (each cycle is 14 days)
Determined per RANO criteria via radiographic evaluation of intracranial tumor lesions.
From subject enrollment until completion of the 8th treatment cycle (each cycle is 14 days)
Duration of Response (DoR)
時間枠：From subject enrollment until completion of the 8th treatment cycle (each cycle is 14 days)
Calculated per RANO criteria based on serial radiographic tumor lesion assessments.
From subject enrollment until completion of the 8th treatment cycle (each cycle is 14 days)
the safe and efficacious dose range
時間枠：From subject enrollment until completion of the 8th treatment cycle (each cycle is 14 days)
Characterized based on the incidence of dose-limiting toxicities (DLTs) and anti-tumor response data assessed per RANO criteria
From subject enrollment until completion of the 8th treatment cycle (each cycle is 14 days)
Objective Response Rate (ORR)
時間枠：From subject enrollment until completion of the 8th treatment cycle (each cycle is 14 days)
Determined per Response Assessment in Neuro-Oncology (RANO criteria) via radiographic evaluation of intracranial tumor lesions.
From subject enrollment until completion of the 8th treatment cycle (each cycle is 14 days)

その他の成果指標

結果測定
メジャーの説明
時間枠
Neoantigen-specific T cell count
時間枠：From subject enrollment to the end of the 8th treatment cycle (each treatment cycle lasts 14 days)
Peripheral blood mononuclear cells (PBMCs) collected at scheduled visits to quantify neoantigen-specific T cell counts by IFN-γ ELISpot assay.
From subject enrollment to the end of the 8th treatment cycle (each treatment cycle lasts 14 days)
T cell activation phenotypes
時間枠：From subject enrollment to the end of the 8th treatment cycle (each treatment cycle lasts 14 days)
Peripheral blood mononuclear cells (PBMCs) collected at scheduled visits to detect activation phenotypes of neoantigen-specific T cells via multi-color flow cytometry.
From subject enrollment to the end of the 8th treatment cycle (each treatment cycle lasts 14 days)
Cytokine secretion level of neoantigen-specific T cells
時間枠：From subject enrollment to the end of the 8th treatment cycle (each treatment cycle lasts 14 days)
Peripheral blood plasma collected at scheduled visits to measure cytokine secretion of neoantigen-specific T cells using ELISA assay.
From subject enrollment to the end of the 8th treatment cycle (each treatment cycle lasts 14 days)
T cell receptor clonotype diversity and clonal expansion
時間枠：From subject enrollment to the end of the 8th treatment cycle (each treatment cycle lasts 14 days)
Peripheral blood mononuclear cells (PBMCs) collected at scheduled visits to analyze neoantigen-specific T cell receptor clonotype diversity and clonal expansion by full-length TCR sequencing.
From subject enrollment to the end of the 8th treatment cycle (each treatment cycle lasts 14 days)

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

Huanhu Hospital Affiliated to Tianjin Medical University

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 (推定)

2026年6月30日

一次修了 (推定)

2027年11月30日

研究の完了 (推定)

2028年5月30日

試験登録日

最初に提出

2026年6月5日

QC基準を満たした最初の提出物

2026年6月24日

最初の投稿 (実際)

2026年7月1日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月1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24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

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 202603241156000268775

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?

いいえ

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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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