Actively Recruiting
Exploratory Clinical Study of Claudin18.2-Targeted Activated DC and CAR-T Therapy in Advanced Pancreatic Cancer.
Led by Hainan Cancer Hospital · Updated on 2026-02-18
10
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
Sponsors
H
Hainan Cancer Hospital
Lead Sponsor
F
Frontiergate Biopharm（Hainan） Co., LTD
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Exploratory Clinical Study of Claudin18.2-Targeted Activated DC and CAR-T Therapy in Advanced Pancreatic Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years, any gender
- Confirmed advanced pancreatic cancer diagnosis with at least one measurable lesion by RECIST v1.1
- Tumor positive for Claudin 18.2 with expression intensity ≥ 2+ and expression range ≥ 50%
- Eligible for PBMC collection without contraindications
- Failure of standard second-line treatment or refusal of chemotherapy
- ECOG performance status 0-1
- Life expectancy of at least 3 months
- Resolved toxic reactions from previous treatments with acceptable functional status
- Sufficient immune function: ALC ≥ 0.5 × 10⁹/L, ANC ≥ 1.0 × 10⁹/L, monocyte count ≥ 0.1 × 10⁹/L
- Sufficient hematopoietic function: platelet count ≥ 75 × 10⁹/L, hemoglobin ≥ 90 g/L; no recent blood transfusions or stimulating treatments within 14 days
- Adequate liver function: TBIL < 2 × ULN, AST and ALT < 2.5 × ULN
- Adequate kidney function: creatinine ≤ 1.5 × ULN
- Adequate coagulation: PT or APTT < 1.5 × ULN, INR < 1.5
- Willingness to use contraception if of reproductive potential
- Ability to understand and sign informed consent
- Willingness to comply with study visits, medications, and tests
You will not qualify if you...
- Emergency oncological conditions needing immediate treatment such as malignant pericardial effusion, tamponade, superior vena cava obstruction syndrome, or spinal cord compression
- Significant cardiovascular disease including recent myocardial infarction, angina, heart failure, severe arrhythmia, or recent coronary procedures within 6 months
- Clinically significant QT interval prolongation (QTcF > 470ms for women, > 450ms for men)
- Bleeding disorders such as hemophilia
- Infection with HIV, syphilis, hepatitis B or C
- History of involuntary custody for mental illness or unsuitable mental health for treatment
- Other autoimmune diseases or long-term use of immunosuppressants or steroids
- Poor compliance as judged by the investigator
- Previous CAR-T treatment targeting the same antigen within 3 months
- Uncontrolled active bacterial or fungal infections
- Other conditions considered exclusionary by the physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hainan Cancer Hospital
Haikou, Hainan, China, 570311
Actively Recruiting
Research Team
H
HAIFENG LIN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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