Clinical Study on the Safety and Efficacy of specific TIL-TCM cells for advanced relapse-refractory or metastatic pancreatic cancer.
This is a single arm, open-label, single-center study.This study is indicated for advanced relapse-refractory or metastatic pancreatic cancer.The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. Primary objective is to explore the safety, main consideration is dose-related safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Abraxane:100-200 mg/m2,QD×1D;Cyclophosphamide:15-35 mg/kg/d,QD×2D. Biological: Adoptive TIL-TCM transfer therapy
Jinling Hospital
Nanjing, Jiangsu, China
RECRUITINGDose-limiting toxicity (DLT)
To evaluate the Safety and Effectiveness of specific TIL-TCM cells in the Treatment of patients with advanced relapse-refractory or metastatic pancreatic cancer
Time frame: Baseline up to 28 days after TIL-TCM cells infusion
Maximum Tolerated Dose(MTD)
To evaluate the Safety and Effectiveness of specific TIL-TCM cells in the Treatment of patients with advanced relapse-refractory or metastatic pancreatic cancer
Time frame: Baseline up to 28 days after TIL-TCM cells infusion
incidence of adverse events( AE )and Serious adverse events(SAE)
Adverse events assessed according to NCI-CTCAE v5.0 criteria.
Time frame: up to 72 weeks after TIL-TCM cells infusion
Overall response rate (ORR)
ORR is defined as the percentage of patients who have a clinical response (objective tumor regression).ORR is computed by: the sum of the number of patients with Complete Response (CR) and number of patients with Partial Response (PR) / total number of patients. The total number of patients is the sum of the number of patients with CR, PR, stable disease (SD) or progressive disease (PD). The Response Evaluation Criteria in Solid Tumors (RECIST v1.1) is used as the criteria to determine whether a tumor disappears (CR), shrinks (PR), stays the same (SD) or gets bigger (PD).
Time frame: 18 months
Duration of response (DOR)
DOR is the time between the initial response to treatment per RECIST v1.1 and subsequent disease progression among patients achieving Complete Response (CR) or Partial Response (PR). RECIST v1.1 is used as the criteria to determine whether a tumor disappears (CR) or shrinks (PR).
Time frame: 18 months
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Progression-free survival (PFS)
PFS is the length of time from the date patient enrolled in to the date on which tumor progresses or the patient dies for any cause.
Time frame: 18 months