Actively Recruiting
Exploratory Clinical Study of Targeted Activated DC and CAR-T Therapy in Patients With Advanced Solid Cancers
Led by Hainan Cancer Hospital · Updated on 2026-03-16
10
Participants Needed
1
Research Sites
26 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
Researchers are evaluating the safety and early effectiveness of a combination of Targeted Activated Dendritic Cells (DCs) and CAR-T cell therapy in adults with advanced solid cancers. This early-phase clinical study focuses on how activating dendritic cells can help target tumors more precisely, change the tumor immune environment, and improve the ability of CAR-T cells to attack cancer cells more deeply and persistently. Participants will receive a treatment involving their own genetically modified dendritic cells and T cells, designed to express chimeric antigen receptors (CAR). This combined therapy aims to better penetrate tumors and kill cancer cells. The study is open-label and single-arm, meaning all participants receive this combination therapy. The treatment and follow-up will continue for up to two years to monitor effects and safety. During the study, participants will have regular visits for evaluations including laboratory tests, imaging, and monitoring of adverse events for two years after receiving the cell infusion. Researchers will measure safety by tracking adverse events and assess effectiveness by looking at tumor response rates, disease control, progression-free survival, and changes in the immune environment within one month after treatment. Participants must comply with scheduled visits and procedures throughout the study.
CONDITIONS
Brief 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 18 to 75 years, any gender
- Advanced solid tumors confirmed by pathology with at least one measurable lesion meeting RECIST 1.1
- Tumor tissue positive for Claudin 18.2, GCC, TROP2, or PSMA targets by immunohistochemistry with expression intensity ≥ 2+ and ≥ 40% positive cells
- Eligible for PBMC collection without contraindications
- Failed standard second-line treatment, lack a standard treatment, or refuse chemotherapy with signed documentation
- ECOG performance status 0-1
- Life expectancy of at least 3 months
- Resolved toxicities from prior treatments except alopecia, with organ functions meeting criteria
- Adequate immune, hematopoietic, liver, renal, and coagulation functions as specified
- Use of effective contraception if of childbearing potential
- Ability and willingness to sign informed consent
- Willingness and ability to comply with study visits, treatments, and tests
You will not qualify if you...
- Oncological emergencies requiring immediate intervention such as malignant pericardial effusion, tamponade, superior vena cava syndrome, or spinal cord compression
- Significant cardiovascular disease including major events in past 6 months or clinically significant QT prolongation
- Bleeding tendency or coagulation disorders
- Active infections with HIV, syphilis, HBV, or HCV
- History of involuntary psychiatric commitment or unsuitable psychiatric conditions
- Concurrent autoimmune diseases or long-term immunosuppressant or corticosteroid use
- Poor compliance as assessed by investigator
- Prior targeted CAR-T cell therapy within 3 months before infusion
- Uncontrolled active bacterial or fungal infections
- Any other condition making the patient ineligible as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years post cell infusion
Participants receive targeted activated dendritic cells and CAR-T cell therapy to treat advanced solid cancers.
1 baseline visit and multiple follow-up visits over 2 years
Duration - Up to 2 years post cell infusion
Participants are monitored for adverse events, disease progression, and immune changes after treatment.
Regular visits during 2-year follow-up period
Trial Site Locations
Total: 1 location
1
Hainan Cancer Hospital
Haikou, Hainan, China, 570311
Actively Recruiting
Research Team
H
HAIFENG LIN
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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