Prospective, single center, single-arm, open label, interventional study evaluating adoptive cell therapy (ACT) with autologous tumor infiltrating lymphocytes (TIL) infusion followed by IL-2 after a non-myeloablative (NMA) lymphodepletion preparative regimen for the treatment of patients with recurrent, metastatic cervical carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
a single center, single-arm, open label, interventional study
Shanghai general hospital
Shanghai, Shanghai Municipality, China
RECRUITINGdose limited toxicity, DLT
Safety and tolerability of TILs, as determined by the rate of Dose Limiting Toxicities (DLTs)
Time frame: 28 days
Objective Response Rate, ORR
To evaluate the efficacy of TILs in patients with recurrent, metastatic cervical carcinoma 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: three months
Duration of Response, DOR
To evaluate the efficacy parameters of TILs in patients with recurrent, metastatic cervical carcinoma by assessing duration of response (DOR) as assessed by the IRC per RECIST v1.1
Time frame: two years
Progression-Free Survival, PFS
To evaluate the efficacy parameters of TILs in patients with recurrent, metastatic cervical carcinoma by assessing progression-free survival (PFS) as assessed by the IRC per RECIST v1.1
Time frame: two years
overall survival, OS
To evaluate overall survival (OS) in patients with recurrent, metastatic cervical carcinoma
Time frame: two years
Disease Control Rate, DCR
To evaluate the efficacy of TILs in patients with recurrent, metastatic cervical carcinoma by assessing disease control rate (DCR) as assessed by the Investigator per RECIST v1.1
Time frame: two years
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