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

NCT07678138 | Not Yet Recruiting

• 1 other identifier: 202603241156000268775
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Glioblastoma

Keywords

Glioblastoma; Immune cell therapy; Dendritic cell (DC); Tumor neoantigen

Outcome Measures

Primary Outcomes (2)

• Safety and Treatment Tolerability

  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)

  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)

Secondary Outcomes (4)

• Disease Control Rate (DCR)

  From subject enrollment until completion of the 8th treatment cycle (each cycle is 14 days)

• Duration of Response (DoR)

  From subject enrollment until completion of the 8th treatment cycle (each cycle is 14 days)

• the safe and efficacious dose range

  From subject enrollment until completion of the 8th treatment cycle (each cycle is 14 days)

• Objective Response Rate (ORR)

  From subject enrollment until completion of the 8th treatment cycle (each cycle is 14 days)

Other Outcomes (4)

• Neoantigen-specific T cell count

  From subject enrollment to the end of the 8th treatment cycle (each treatment cycle lasts 14 days)

• T cell activation phenotypes

  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

  From subject enrollment to the end of the 8th treatment cycle (each treatment cycle lasts 14 days)

Study Arms (1)

Neoantigen DC Vaccine (YS247) for Glioblastoma

EXPERIMENTAL

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.

Biological: Neoantigen DC Vaccine (YS247) for Glioblastoma

Interventions

Neoantigen DC Vaccine (YS247) for Glioblastoma BIOLOGICAL

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

Neoantigen DC Vaccine (YS247) for Glioblastoma

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huanhu Hospital Affiliated to Tianjin Medical University: lead

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

Xiaomin Liu, Chief Physician

CONTACT

13502068866; liuxiaomintj@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: July 1, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): May 30, 2028
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share