This study is an open, single-arm, dose-escalating phase I exploratory clinical trial to observe the safety, tolerability and preliminary efficacy of different doses of TILs in the treatment of relapsed and refractory NSCLC(Non-small cell lung cancer). The study includes 7 stages: ① screening period; ② tissue collection; ③ TILs cell production and preparation; ④ lymphocyte depletion pretreatment; ⑤ TILs cell infusion; ⑥ safety and efficacy evaluation; ⑦ follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
10e9, 10e10, 10e11 dose range of TILs, 3+3 dose escalation
DLT(Dose limiting toxicity)
The severity of adverse events is graded according to NCT-CTCAE version 5.0, and the investigator will determine whether the subject has DLT. DLT is defined as: Grade 3 or above (CTCAE version 5.0) possible or confirmed related symptoms, laboratory toxicity and clinical events caused by the study treatment within 28 days after transfusion of TILs cells.
Time frame: 28 days
Objective Response Rate, ORR
To evaluate the efficacy of TILs in patients with NSCLC based on the objective response rate (ORR) as assessed by the Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: 3 Months
Duration of Response, DOR
To evaluate the efficacy parameters of TILs in patients with NSCLC by assessing duration of response (DOR) as assessed by the IRC per RECIST v1.1
Time frame: 2 years
Progression-Free Survival, PFS
To evaluate the efficacy parameters of TILs in patients with NSCLC by assessing progression-free survival (PFS) as assessed by the IRC per RECIST v1.1
Time frame: 2 years
overall survival, OS
To evaluate overall survival (OS) in patients with NSCLC
Time frame: 2 years
Disease Control Rate, DCR
To evaluate the efficacy of TILs in patients with NSCLC by assessing disease control rate (DCR) as assessed by the Investigator per RECIST v1.1
Time frame: 2 years
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