To investigate the safety, tolerability, efficacy and pharmacokinetics of TCR-T cells in the treatment of advanced pancreatic cancer
The aim of this clinical trial is to investigate the safety, tolerability, efficacy and pharmacokinetics of TCR-T cell therapy in patients with advanced pancreatic cancer by intravenous injection, in order to explore an effective cellular immunotherapy method for the treatment of advanced pancreatic cancer
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
The TCRT cells used in this clinical trial were derived from the patient's autologous peripheral-blood T cells and were genetically transduced to express a T-cell Receptor that recognizes the RAS/TP53.Patients were sequentially enrolled into 3 dose escalation groups(dose level 1-3) :5×10\^8±20%,5×10\^9±20%,5×10\^10±20%.
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGEvaluate the Incidence of Treatment Related Adverse Events of TCRT cells in patients with advanced pancreatic cancer
collect adverse events (AE), serious adverse events (SAE), adverse events of special interest (AESI), and laboratory abnormalities (type, frequency, and severity)
Time frame: 2years
Characterize the Peak of Peripheral Blood Concentration and Area under the Peripheral Blood concentration versus time curve of TCRT cells and observe their proliferation and persistence in body
After infusion of neoantigen-specific TCRT cells, collect peak (Cmax) of neoantigen-specific TCRT cells in blood and tumor tissue, time to peak (number of days to peakTCRT cells after infusion), Tmax) and AUC0-28 (area under the curve plotted against visit time by the number of neoantigen-specific TCRT cells in peripheral blood from day 0 to 28). "If possible, AUC0-inf, terminal phase elimination rate constant (λz), elimination half-life (t1/2) will be evaluated."
Time frame: 2years
Correlation of the pharmacokinetic profile of TCRT cells with the Incidence of CRS and ICANS events
collect changes in mutant cell concentration in peripheral blood and tumor tissue after TCRT cell reinfusion,observe correlation of these measures with CRS and ICANS events
Time frame: 2years
Evaluate tumor size (mm) , tumor biomarker CA19-9 (U/ml), ORR/DCR/PFS and OS of patients with advanced pancreatic cancer
ORR at 2, 4, and 6 months after TCRT cell infusion (ORR=CR+PR). The primary efficacy outcome was the change in target tumor size (local control rate of target lesions). Secondary efficacy indicators: changes in tumor markers; Objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS) according to RECIST1.1 criteria
Time frame: 2years
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