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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 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Studietype

Ingrijpend

Inschrijving (Geschat)

9

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Biologisch: 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Safety and Treatment Tolerability
Tijdsspanne: 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)
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Disease Control Rate (DCR)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Neoantigen-specific T cell count
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Huanhu Hospital Affiliated to Tianjin Medical University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

30 juni 2026

Primaire voltooiing (Geschat)

30 november 2027

Studie voltooiing (Geschat)

30 mei 2028

Studieregistratiedata

Eerst ingediend

5 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

24 juni 2026

Eerst geplaatst (Werkelijk)

1 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

24 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 202603241156000268775

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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