This is an open-label, single-arm clinical study designed to evaluate the safety and preliminary efficacy of Claudin18.2 Targeted Activated DC combined with CAR-T therapy in patients with Advanced Pancreatic Cancer. This combination therapy activates dendritic cells (DCs) to precisely target the tumor site, reshaping the tumor immune microenvironment, breaking down the immunosuppressive barrier, and allowing CAR-T cells to penetrate deeper into the tumor more efficiently, precisely and persistently killing cancer cells.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Autologous dendritic cells (DCs) genetically modified to express Claudin18.2 chimeric antigen receptor (CAR) and activation domain
Autologous T cells genetically modified to express Claudin18.2 chimeric antigen receptor (CAR)
Hainan Cancer Hospital
Haikou, Hainan, China
RECRUITINGAdverse Events (AEs)
Incidence and severity of adverse events
Time frame: 2 years
Objective Response Rate (ORR)
The percentage of participants who achieved Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1
Time frame: 2 years
Disease Control Rate (DCR)
The percentage of participants who achieved Complete Response (CR) or Partial Response (PR) or Stable disease (SD) based on RECIST version 1.1
Time frame: 2 years
Progression-free survival (PFS)
PFS is defined as the time from the date of cell infusion until the date of tumor progression or death from any cause
Time frame: 2 years
Changes in the Immune Microenvironment
Assess the changes in the tumor immune microenvironment before and after subjects received combined therapy with Claudin18.2 targeted activated dendritic cells (DCs) and CAR-T cells.
Time frame: 1 month
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