Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Frontiergate Biopharm(Hainan) Co., LTD | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Targeted Activated Dendritic Cells | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Targeted Activated Dendritic Cells | Biological | Autologous dendritic cells (DCs) genetically modified to express chimeric antigen receptor (CAR) and activation domain |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse 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. | 2 years post cell infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | The percentage of participants who achieved Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1 | 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 |
Not provided
Inclusion Criteria:
Age ≥ 18 years and ≤ 75 years, regardless of gender;
Advanced solid tumors with clear pathological confirmation, including but not limited to gastric cancer, colorectal cancer, pancreatic cancer, prostate cancer, etc.; at least one measurable lesion meeting RECIST 1.1 criteria (according to RECIST 1.1, the longest diameter of a measurable lesion on spiral CT scan ≥ 10 mm, or the short diameter of a pathological lymph node ≥ 15 mm);
Tumor tissue positive for Claudin 18.2, GCC, TROP2, or PSMA targets by immunohistochemistry (IHC) (expression intensity ≥ 2+; percentage of positive cells ≥ 40%);
Meets the indications for PBMC collection and has no contraindications for cell collection;
Failure of standard second-line treatment, or lack of a standard treatment regimen; or refusal to receive chemotherapy (with signed documentation);
ECOG performance status: 0-1;
Life expectancy: ≥ 3 months;
Toxicities from prior chemotherapy or other anti-tumor therapies must have resolved after a washout period (except for residual alopecia), ensuring that all organ functions meet the inclusion criteria;
Adequate organ function, including:
Individuals of childbearing potential must agree to use effective contraception during the study;
Ability to understand and willingness to sign a written informed consent form;
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Exclusion Criteria:
Oncological emergencies requiring immediate intervention, such as malignant pericardial effusion or tamponade, superior vena cava syndrome, or spinal cord compression;
Significant cardiovascular disease, including:
Clinically significant bleeding tendency or coagulation disorders (e.g., hemophilia);
Active infection with HIV, syphilis, hepatitis B virus (HBV), or hepatitis C virus (HCV);
History of involuntary commitment due to mental illness, or any psychiatric condition deemed by the investigator to make the patient unsuitable for the trial;
Concurrent autoimmune diseases, or long-term use of immunosuppressants or systemic corticosteroids;
Poor compliance, as assessed by the investigator;
Prior treatment with any targeted CAR-T cell therapy within 3 months before this CAR-T infusion;
Uncontrolled active bacterial or fungal infections;
Any other condition that, in the opinion of the investigator, makes the patient ineligible for the study.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| HAIFENG LIN | Contact | +86-13322060949 | 13322060949@163.com |
| Name | Affiliation | Role |
|---|---|---|
| HAIFENG LIN | Hainan Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hainan Cancer Hospital | Recruiting | Haikou | Hainan | 570311 | China |
Yes. De-identified individual participant data that support the findings of this study will be made available upon reasonable request.The data will be available beginning 6 months and ending 5 years following publication.Requests should be submitted to the corresponding author and will be reviewed based on scientific merit. Data will be shared after approval and signing of a data use agreement.
Beginning 6 months after publication and ending 5 years following publication.
Access will be granted to researchers with a sound scientific proposal after review and approval, and with a signed data use agreement.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Targeted CAR-T Cells | Biological | Autologous T cells genetically modified to express chimeric antigen receptor (CAR) |
|
| 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 | 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). | 1 month post cell infusion |