A Study of GC101 TIL in Advanced Breast Cancer (10hospital)
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 (GC 101 TIL) in patients with advanced breast cancer. Autologous TILs are expanded from tumor resections or biopsies 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 breast cancer;
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 groupSponsors and collaborators
Shanghai Juncell Therapeutics
Lead sponsor
Shanghai 10th People's Hospital
Collaborator
Source ClinicalTrials.gov