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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Adoptive transfer of 1x10\^9-5x10\^10 autologous TILs to patients i.v. in 30-120 minutes.
Shanghai Tenth People's Hospital
Shanghai, China
RECRUITINGAdverse Events (AE)
To characterize the safety profile of GC101 TIL in patients with advanced breast cancer as assessed by incidence of adverse events.
Time frame: 6 months
Objective Response Rate (ORR)
Proportion of patients with response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1): ORR (proportion of patients) = # with CR + # with PR / # with CR + # with PR + # with SD + # with PD. ( Except baseline evaluation within 28 days before GC101 TIL infusion,PET/CT scan will be performed at 6 weeks after TIL infusion, and than every 6 weeks for 6 months, and then every 6 months after that for up to 3 years)
Time frame: Up to 36 months
Disease Control Rate (DCR)
Percentage of patients that meet CR, PR and SD criteria set in this study according to RECIST v1.1: DCR (proportion of patients) = # with CR + # with PR + # with SD / # with CR + # with PR + # with SD + # with PD.
Time frame: Up to 36 months
Duration of Response (DOR)
The time length between the first confirmed objective response per RECIST 1.1 to the treatment and the subsequent disease progression per RECIST 1.1
Time frame: Up to 36 months
Progression-Free Survival (PFS)
The time length between GC101 TIL infusion and confirmed subsequent disease progression according to RECIST 1.1
Time frame: Up to 36 months
Overall Survival (OS)
The length of time from the date of the start of GC101 TIL treatment that the patients are still alive
Time frame: Up to 36 months
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Change in Quality of Life
Comparison of patients' quality of life before and after GC101 TIL treatment as assessed by the EORTC QLQ-30 (V3.0).
Time frame: Up to 36 months