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- Ensaio Clínico NCT07678138
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
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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Xiaomin Liu, Chief Physician
- Número de telefone: 13502068866
- E-mail: liuxiaomintj@126.com
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Age 18-75 years (inclusive), any gender.
- Histologically confirmed GBM (WHO Grade IV).
- 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.
- KPS score ≥60, expected survival ≥6 months.
- ECOG score 0-2.
- Bridging therapy allowed during sample preparation; washout ≥7 days or 5 half-lives (whichever longer) before initial treatment.
- Radiotherapy completed ≥8 weeks before study drug initiation.
- Toxicity from prior anti-tumor therapy recovered to CTCAE V5.0 Grade 1 or below (except alopecia).
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
- Adequate venous access for PBMC collection, no contraindications.
- Sufficient tumor and blood samples for NGS via resection or biopsy.
- Negative serum pregnancy test (fertile females); effective contraception throughout screening, study, and 6 months after last dose for fertile participants/partners.
- Compliance with study procedures and follow-up.
- Voluntary participation and signed informed consent.
Exclusion Criteria:
- Any other active malignancy.
- Participation in another clinical trial within 4 weeks before enrollment.
- Prior gene transfer therapy.
- 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.
- Live virus/recombinant vaccine within 4 weeks before first treatment; expected need for live attenuated vaccine within 6 months after last dose.
- Severe allergy or hypersensitivity.
- MRI contrast contraindications (pacemaker, pump, contrast allergy).
- Positive HIV, HBV, HCV, or TP.
- Primary/secondary immunodeficiency or autoimmune disease (SLE, RA, IBD, autoimmune thyroid disease, autoimmune hepatitis, MS, vasculitis, glomerulonephritis, psoriasis, uncontrolled asthma).
- Severe infection within 1 month before treatment, uncontrolled infection, or antibiotics in the past week (except prophylaxis).
- 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).
- Uncontrolled systemic disease (NYHA III/IV heart failure, unstable angina, MI, cirrhosis, renal failure, severe lung disease, hematological/gastrointestinal/organ failure, diabetes, uncontrolled hypertension).
- ICD-11 psychiatric/neurological disorders (epilepsy, schizophrenia, dementia, addiction) per investigator judgment.
- Clinically significant bleeding within 3 months or bleeding diathesis; arterial/venous thromboembolism within 6 months (TIA, stroke, DVT, PE).
- Irreversible electrolyte imbalance.
- Anti-tumor therapy before apheresis: cytotoxic within 14 days; investigational within 28 days; immunomodulator within 7 days; targeted within 28 days.
- Pregnant or lactating female.
- Any other condition deemed unsuitable by the investigator.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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.
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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
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Safety and Treatment Tolerability
Prazo: From subject enrollment until completion of the 8th treatment cycle (each cycle is 14 days)
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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.
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From subject enrollment until completion of the 8th treatment cycle (each cycle is 14 days)
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Maximum Tolerated Dose (MTD) and Recommended Expanded Dose(RP2D)
Prazo: From subject enrollment until completion of the 8th treatment cycle (each cycle is 14 days)
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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:
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From subject enrollment until completion of the 8th treatment cycle (each cycle is 14 days)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Disease Control Rate (DCR)
Prazo: From subject enrollment until completion of the 8th treatment cycle (each cycle is 14 days)
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Determined per RANO criteria via radiographic evaluation of intracranial tumor lesions.
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From subject enrollment until completion of the 8th treatment cycle (each cycle is 14 days)
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Duration of Response (DoR)
Prazo: From subject enrollment until completion of the 8th treatment cycle (each cycle is 14 days)
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Calculated per RANO criteria based on serial radiographic tumor lesion assessments.
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From subject enrollment until completion of the 8th treatment cycle (each cycle is 14 days)
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the safe and efficacious dose range
Prazo: From subject enrollment until completion of the 8th treatment cycle (each cycle is 14 days)
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Characterized based on the incidence of dose-limiting toxicities (DLTs) and anti-tumor response data assessed per RANO criteria
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From subject enrollment until completion of the 8th treatment cycle (each cycle is 14 days)
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Objective Response Rate (ORR)
Prazo: 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.
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From subject enrollment until completion of the 8th treatment cycle (each cycle is 14 days)
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Neoantigen-specific T cell count
Prazo: From subject enrollment to the end of the 8th treatment cycle (each treatment cycle lasts 14 days)
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Peripheral blood mononuclear cells (PBMCs) collected at scheduled visits to quantify neoantigen-specific T cell counts by IFN-γ ELISpot assay.
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From subject enrollment to the end of the 8th treatment cycle (each treatment cycle lasts 14 days)
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T cell activation phenotypes
Prazo: From subject enrollment to the end of the 8th treatment cycle (each treatment cycle lasts 14 days)
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Peripheral blood mononuclear cells (PBMCs) collected at scheduled visits to detect activation phenotypes of neoantigen-specific T cells via multi-color flow cytometry.
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From subject enrollment to the end of the 8th treatment cycle (each treatment cycle lasts 14 days)
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Cytokine secretion level of neoantigen-specific T cells
Prazo: From subject enrollment to the end of the 8th treatment cycle (each treatment cycle lasts 14 days)
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Peripheral blood plasma collected at scheduled visits to measure cytokine secretion of neoantigen-specific T cells using ELISA assay.
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From subject enrollment to the end of the 8th treatment cycle (each treatment cycle lasts 14 days)
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T cell receptor clonotype diversity and clonal expansion
Prazo: From subject enrollment to the end of the 8th treatment cycle (each treatment cycle lasts 14 days)
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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.
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From subject enrollment to the end of the 8th treatment cycle (each treatment cycle lasts 14 days)
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Colaboradores e Investigadores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 202603241156000268775
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