OncoMatch/Clinical Trials/NCT04943913
Study of GC101 TIL in Brain Glioma (Soochow2)
Is NCT04943913 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies Tumor Infiltrating Lymphocytes (TIL) for glioma.
Treatment: Tumor Infiltrating Lymphocytes (TIL) — This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with malignant glioma . Autologous TILs are expanded from tumor resections and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Performance status
KARNOFSKY/ECOG 0–2
Karnofsky≥60% or ECOG score 0-2
Prior therapy
Must have received: standard treatment regimens
Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available.
Cannot have received: malignant tumor-targeting therapies (including radiotherapy, chemotherapy and biologics)
Any malignant tumor-targeting therapies, including radiotherapy, chemotherapy and biologics must cease 28 days before obtaining TILs
Cannot have received: other medicines, or other biologic therapy, chemo-or radiotherapy
Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy
Cannot have received: immunotherapy with irAE > Level 3
Having received immunotherapy and developed irAE level greater than Level 3
Lab requirements
Blood counts
Absolute count of white blood cells≥2.5×10^9/L; Absolute count of neutropils≥1.5×10^9/L; Absolute count of lymphocytes ≥0.7×10^9/L; Platelet count≥100×10^9; hemoglobin≥90 g/L; Activated partial thromboplastin time (APTT) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days); International normalized ratio (INR) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days)
Kidney function
Serum creatinine ≤1.5mg/dL (or ≤132.6μmol/L), or clearance rate≥50mL/min
Liver function
Serum ALT/AST ≤3×ULN (subjects with liver metastasis ≤3×ULN); Totol bilirubin≤1.5×ULN
Cardiac function
No significant cardiovascular anomalies (NYHA Grade III or IV congestive heart failure, clinically significant low blood pressure, uncontrollable symptomatic coronary artery diseases, or ejection fraction less than 35%; severe cardiac rhythm and conduction anomaly, such as ventricular arrhythmia requiring clinical intervention, second-third degree atrio-ventricular conductive block, etc.)
Hematology and Chemistry（within 7 days prior to enrollment）: ... Significant cardiovascular anomalies according to any of the following definition: New York Heart Association (NYHA) Grade III or IV congestive heart failure, clinically significant low blood pressure, uncontrollable symptomatic coronary artery diseases, or ejection fraction less than 35%; Severe cardiac rhythm and conduction anomaly, such as ventricular arrhythmia requiring clinical intervention, second-third degree atrio-ventricular conductive block, etc.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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