A clinical trial to assess the safety and efficacy of engineered Tumor Infiltrating Lymphocytes (TIL) for the treatment of Advanced Malignant Solid Tumors
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
A tumor sample is resected from each participant and cultured ex vivo to generate the engineered tumor infiltrating lymphocytes. After lymphodepletion, patients are infused GC203 TIL followed low-dose PD-1 antibody.
Fudan University Shanghai Cancer Center
Shanghai, China
RECRUITINGMaximal Tolerance Dose
Time frame: Up to Day 28
Dose Limiting Toxicity
Time frame: Up to Day 28
Adverse Events
Time frame: Maximum 360 days
Objective Response Rate
Evaluate the efficacy endpoints of ORR by the investigator with RECIST v1.1 and iRECIST
Time frame: Every 6 weeks for 12 months
Duration of Response
Evaluate the efficacy endpoints of DoR by the investigator with RECIST v1.1 and iRECIST
Time frame: Every 6 weeks for 12 months
Disease Control Rate
Evaluate the efficacy endpoints of DCR by the investigator with RECIST v1.1 and iRECIST
Time frame: Every 6 weeks for 12 months
Progression-Free Survival
Evaluate the efficacy endpoints of PFS by the investigator with RECIST v1.1 and iRECIST
Time frame: Every 6 weeks for 12 months
Overall Survival
Evaluate the efficacy endpoints of OS by the investigator with RECIST v1.1 and iRECIST
Time frame: Every 6 weeks for 12 months
Quality of Life Assessment
Evaluate with EORTC QLQ-C30
Time frame: Every 6 weeks for 12 months
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