This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with malignant refractory/relapsed gynecologic tumors. Autologous TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with fludarabine and cyclophosphamide.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Adoptive transfer of 1x10\^9-3x10\^11 autologous TILs to patients i.v. in 30-120 minutes.
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGIncidence of Serious Adverse Events (SAEs)
Safety assessments. Incidence of Serious Adverse Events (SAEs) and Treatment-Emergent Adverse Events (TEAEs). The severity of all adverse events was graded based on Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.
Time frame: Up to 12 months
Objective Response Rate (ORR)
To evaluate the efficacy of TIL infusion in patients as determined by objective response rate (ORR), which contains complete response (CR) and partial response (PR), using the RECIST v1.1, as assessed by the Investigator. ( CT Scan at 4-6 weeks after TIL infusion, and than every 4-6 weeks for 1 year, and then every six 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 1.1
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 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 TIL treatment that the patients are still alive
Time frame: Up to 36 months
Complete Response(CR)
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Patients with complete response per RECIST 1.1 to TIL treatment
Time frame: Up to 36 months
Partial Response (PR)
Percentage of patients with partial response per RECIST 1.1 to TIL treatment
Time frame: Up to 36 months
Stable Disease (SD)
Patients with stable disease per RECIST 1.1 to TIL treatment
Time frame: Up to 36 months
Progressive Disease (PD)
Patients with progressive disease per RECIST 1.1 to TIL treatment
Time frame: Up to 36 months