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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

2026년 6월 24일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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

연구 유형

중재적

등록 (추정된)

9

단계

  • 해당 없음

연락처 및 위치

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연구 연락처

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

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아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
생물학적: 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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Safety and Treatment Tolerability
기간: 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)
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Disease Control Rate (DCR)
기간: 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)
기간: 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
기간: 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)
기간: 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)

기타 결과 측정

결과 측정
측정값 설명
기간
Neoantigen-specific T cell count
기간: 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
기간: 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
기간: 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
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Huanhu Hospital Affiliated to Tianjin Medical University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 30일

기본 완료 (추정된)

2027년 11월 30일

연구 완료 (추정된)

2028년 5월 30일

연구 등록 날짜

최초 제출

2026년 6월 5일

QC 기준을 충족하는 최초 제출

2026년 6월 24일

처음 게시됨 (실제)

2026년 7월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 24일

마지막으로 확인됨

2026년 6월 1일

추가 정보

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추가 관련 MeSH 약관

기타 연구 ID 번호

  • 202603241156000268775

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아니요

약물 및 장치 정보, 연구 문서

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미국 FDA 규제 기기 제품 연구

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이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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