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

Korábbi kezelés

• 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 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).
• Anti-tumor therapy before apheresis: cytotoxic within 14 days; investigational within 28 days; immunomodulator within 7 days; targeted within 28 days.

Más betegség

• Any other active malignancy.
• 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).
• 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).
• Any other condition deemed unsuitable by the investigator.

Egyéb

• Irreversible electrolyte imbalance.
• Pregnant or lactating female.

• 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.