The purpose of this study is to evaluate the safety, side effects and benefits of autologous tumor infiltrating lymphocytes (TIL) specific to personalized Neo-antigens in the treatment of patients with recurrent, metastatic and advanced solid tumors.
Adoptive cell transfer therapy that utilizes an autologous TIL manufacturing progress is originally developed by the NCI for the treatment of patients with recurrent, metastatic cervical cancer and liver cancer. TILs specific to personalized neo-antigens will be expended in vitro and given back to the patients through vein. A total of 20 patients will be enrolled in the single-arm, open label, interventional study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
On day 0, cells will be infused intravenously over 20 to 30 minutes (one to four days after the last dose of fludarabine)
IL-2 125,000 IU/kg/day IV (based on total body weight) beginning within 24 hours of cell infusion and continuing for up to 2 weeks
On day -7 and day -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGObjective Responce Rate [Time Frame: 24 months after cell infusion]
The Objective Responce Rate of patients received immunotherapy are accesed by the Response Criteria in Solid Tumors (RECIST) v1.0.
Time frame: 24 months after cell infusion
Adverse Event
Aggregate of all adverse events, as well as their frequency and severity are accessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.03).
Time frame: up to 24 months
Disease Control Rate
Disease control rate (DCR) as measured by RECIST 1.1 criteria.
Time frame: up to 24 months
Duration of Response
Duration of response (DOR) as measured by RECIST 1.1 criteria .
Time frame: up to 24 months
Progression-Free Survival
PFS will be summarized using Kaplan-Meier estimates.
Time frame: up to 24 months
Overall Survival
The overall survival of all patients entering the study will be monitored.
Time frame: up to 24 months
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Days -5 to -1: Fludarabine 25 mg /m2/day IVPB daily over 30 minutes for 5 days