Actively Recruiting
Exploratory Clinical Study of Targeted Activated DC and CAR-T Therapy in Advanced Solid Cancers
Led by Hainan Cancer Hospital · Updated on 2026-03-16
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 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.
CONDITIONS
Official Title
Exploratory Clinical Study of Targeted Activated DC and CAR-T Therapy in Advanced Solid Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, any gender
- Diagnosed with advanced solid tumors confirmed by pathology, including gastric, colorectal, pancreatic, or prostate cancer
- At least one measurable tumor lesion meeting RECIST 1.1 criteria
- Tumor tissue positive for Claudin 18.2, GCC, TROP2, or PSMA by immunohistochemistry with expression intensity of 2+ or higher and at least 40% positive cells
- Eligible for peripheral blood mononuclear cell (PBMC) collection with no contraindications
- Failed standard second-line treatment, lack standard treatment options, or declined chemotherapy with signed documentation
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Resolved toxicities from prior therapies except residual hair loss; organ functions meet inclusion standards
- Adequate immune function with lymphocyte count ≥ 0.5 × 10⁹/L, neutrophil count ≥ 1.0 × 10⁹/L, monocyte count ≥ 0.1 × 10⁹/L
- Adequate hematopoietic function with platelet count ≥ 75 × 10⁹/L, hemoglobin ≥ 90 g/L; no blood transfusions or stimulating treatments within 14 days prior
- Adequate liver function: total bilirubin less than 2 times upper limit of normal, AST and ALT less than 2.5 times upper limit of normal
- Adequate kidney function: creatinine less than or equal to 1.5 times upper limit of normal
- Adequate coagulation: PT or APTT less than 1.5 times upper limit of normal, INR less than 1.5
- Agree to use effective contraception if of childbearing potential
- Able to understand and willing to sign informed consent
- Willing and able to follow visits, treatments, tests, and study procedures
You will not qualify if you...
- Presence of oncological emergencies needing immediate treatment, such as malignant pericardial effusion, tamponade, superior vena cava syndrome, or spinal cord compression
- Significant cardiovascular disease including major events in past 6 months (myocardial infarction, angina, heart failure, severe arrhythmia, or major surgeries)
- Clinically significant QT interval prolongation (QTcF > 470 ms for women or > 450 ms for men)
- Significant bleeding disorders or coagulation problems like hemophilia
- Active infections with HIV, syphilis, hepatitis B, or hepatitis C
- History of involuntary psychiatric commitment or mental illness making participation unsuitable
- Autoimmune diseases or long-term use of immunosuppressive or systemic corticosteroid therapies
- Poor compliance as judged by investigators
- Prior targeted CAR-T cell therapy within 3 months before this treatment
- Uncontrolled active bacterial or fungal infections
- Any other conditions deemed unsuitable by the investigator
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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