Study of GC101 TIL in Brain Glioma (Soochow2)

ConditionGlioma
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShanghai Juncell Therapeutics

About this trial

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.

Eligibility criteria

Qualifiers

Age: 18 years to 75 years;

Histologically diagnosed as primary/relapsed/metastasized brain glioma;

Expected life-span more than 3 months;

Karnofsky≥60% or ECOG score 0-2;

Disqualifiers

Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment;

Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%;

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.

Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and/or anti-HCV positive), syphilis infection or Treponema pallidum antibody positive;

Trial design

Treatments tested in this trial

  • Tumor Infiltrating Lymphocytes (TIL)

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators

Shanghai Juncell Therapeutics

Lead sponsor

Second Affiliated Hospital of Soochow University

Collaborator