Personalized vaccine takes aim at recurrent brain tumors

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.