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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

24 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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

Tipo di studio

Interventistico

Iscrizione (Stimato)

9

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Biologico: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Safety and Treatment Tolerability
Lasso di tempo: 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)
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Disease Control Rate (DCR)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Neoantigen-specific T cell count
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Huanhu Hospital Affiliated to Tianjin Medical University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

30 giugno 2026

Completamento primario (Stimato)

30 novembre 2027

Completamento dello studio (Stimato)

30 maggio 2028

Date di iscrizione allo studio

Primo inviato

5 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

24 giugno 2026

Primo Inserito (Effettivo)

1 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

1 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 202603241156000268775

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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