Exploratory Clinical Study of Targeted Activated DC and CAR-T Therapy in Advanced Solid Cancers

Exploratory Clinical Study of Targeted Activated DC and CAR-T Therapy in Patients With Advanced Solid Cancers.

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 Overview

• Status: Recruiting
• Conditions: Advanced Solid Cancers
• Intervention / Treatment: Biological: Targeted Activated Dendritic Cells; Biological: Targeted CAR-T Cells

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: HAIFENG LIN; Phone Number: +86-13322060949; Email: 13322060949@163.com

Study Locations

• China
  • Hainan
    • Haikou, Hainan, China, 570311
      • Recruiting
      • Hainan Cancer Hospital
      • Contact: HAIFENG LIN; Phone Number: 13322060949; Email: 13322060949@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years and ≤ 75 years, regardless of gender;
2. 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);
3. Tumor tissue positive for Claudin 18.2, GCC, TROP2, or PSMA targets by immunohistochemistry (IHC) (expression intensity ≥ 2+; percentage of positive cells ≥ 40%);
4. Meets the indications for PBMC collection and has no contraindications for cell collection;
5. Failure of standard second-line treatment, or lack of a standard treatment regimen; or refusal to receive chemotherapy (with signed documentation);
6. ECOG performance status: 0-1;
7. Life expectancy: ≥ 3 months;
8. 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;

9. Adequate organ function, including:

   1. Adequate immune function: absolute lymphocyte count (ALC) ≥ 0.5 × 10⁹/L, absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L, monocyte count ≥ 0.1 × 10⁹/L.
   2. Adequate hematopoietic function: platelet count ≥ 75 × 10⁹/L, hemoglobin ≥ 90 g/L. Patients must not have received blood transfusions or treatments such as granulocyte colony-stimulating factor, thrombopoietin, or erythropoietin within 14 days prior to the blood count assessment.
   3. Adequate liver function: total bilirubin (TBIL) < 2 × upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 × ULN.
   4. Adequate renal function: creatinine (Cr) ≤ 1.5 × ULN.
   5. Adequate coagulation function: prothrombin time (PT) or activated partial thromboplastin time (APTT) < 1.5 × ULN, and international normalized ratio (INR) < 1.5.
10. Individuals of childbearing potential must agree to use effective contraception during the study;
11. Ability to understand and willingness to sign a written informed consent form;
12. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion Criteria:

1. Oncological emergencies requiring immediate intervention, such as malignant pericardial effusion or tamponade, superior vena cava syndrome, or spinal cord compression;

2. Significant cardiovascular disease, including:

   1. Documented major cardiovascular events within the past 6 months, such as myocardial infarction, angina pectoris, heart failure, severe arrhythmia, or prior angioplasty, stent implantation, or coronary artery bypass grafting;
   2. Clinically significant QT interval prolongation (QTcF > 470 ms for women or QTcF > 450 ms for men);
3. Clinically significant bleeding tendency or coagulation disorders (e.g., hemophilia);
4. Active infection with HIV, syphilis, hepatitis B virus (HBV), or hepatitis C virus (HCV);
5. History of involuntary commitment due to mental illness, or any psychiatric condition deemed by the investigator to make the patient unsuitable for the trial;
6. Concurrent autoimmune diseases, or long-term use of immunosuppressants or systemic corticosteroids;
7. Poor compliance, as assessed by the investigator;
8. Prior treatment with any targeted CAR-T cell therapy within 3 months before this CAR-T infusion;
9. Uncontrolled active bacterial or fungal infections;
10. Any other condition that, in the opinion of the investigator, makes the patient ineligible for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Targeted Activated Dendritic Cells	Biological: Targeted Activated Dendritic Cells; Autologous dendritic cells (DCs) genetically modified to express chimeric antigen receptor (CAR) and activation domain; Biological: Targeted CAR-T Cells; Autologous T cells genetically modified to express chimeric antigen receptor (CAR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Hainan Cancer Hospital
• Collaborators: Frontiergate Biopharm（Hainan） Co., LTD
• Investigators: Principal Investigator: HAIFENG LIN, Hainan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2025
• Primary Completion (Estimated): December 6, 2027
• Study Completion (Estimated): June 6, 2028

Study Registration Dates

• First Submitted: March 5, 2026
• First Submitted That Met QC Criteria: March 11, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: EC-2025-041-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Beginning 6 months after publication and ending 5 years following publication.
• IPD Sharing Access Criteria: Access will be granted to researchers with a sound scientific proposal after review and approval, and with a signed data use agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No