This is an open-label, single-arm clinical study designed to evaluate the safety and preliminary efficacy of Targeted Activated DC combined with CAR-T therapy in patients with Advanced Solid Cancers.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 chimeric antigen receptor (CAR) and activation domain
Autologous T cells genetically modified to express chimeric antigen receptor (CAR)
Hainan Cancer Hospital
Haikou, Hainan, China
RECRUITINGAdverse Events (AEs)
To evaluate adverse events following infusion of targeted activated dendritic cells (DC) and CAR-T cells, with an assessment of the incidence and severity of treatment-related toxicities, including cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), hematological abnormalities, infections, autoimmune reactions, and secondary malignancies.
Time frame: 2 years post cell infusion
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 (TIME) following combined therapy with targeted activated dendritic cells (DCs) and CAR-T cells. The analysis will focus on the composition, density, and functional status of key immune cell populations, including T cell subsets (e.g., CD4+, CD8+), B cells, DC subsets, tumor-associated macrophages (TAMs), and regulatory T cells (Tregs).
Time frame: 1 month post cell infusion
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