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

NCT07475182 | Recruiting Early Phase 1 DMC

• 1 other identifier: EC-2025-041-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Advanced Solid Cancers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Objective Response Rate (ORR)

  2 years

• Disease Control Rate (DCR)

  2 years

• Progression-free survival (PFS)

  2 years

• Changes in the Immune Microenvironment

  1 month post cell infusion

Study Arms (1)

Targeted Activated Dendritic Cells

EXPERIMENTAL

Biological: Targeted Activated Dendritic Cells; Biological: Targeted CAR-T Cells

Interventions

Targeted Activated Dendritic Cells BIOLOGICAL

Autologous dendritic cells (DCs) genetically modified to express chimeric antigen receptor (CAR) and activation domain

Targeted Activated Dendritic Cells

Targeted CAR-T Cells BIOLOGICAL

Autologous T cells genetically modified to express chimeric antigen receptor (CAR)

Targeted Activated Dendritic Cells

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Adequate organ function, including:
• 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.
• 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.
• Adequate liver function: total bilirubin (TBIL) \< 2 × upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 × ULN.
• Adequate renal function: creatinine (Cr) ≤ 1.5 × ULN.
• Adequate coagulation function: prothrombin time (PT) or activated partial thromboplastin time (APTT) \< 1.5 × ULN, and international normalized ratio (INR) \< 1.5.
• 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;

You may not qualify if:

• Oncological emergencies requiring immediate intervention, such as malignant pericardial effusion or tamponade, superior vena cava syndrome, or spinal cord compression;
• Significant cardiovascular disease, including:
• 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;
• Clinically significant QT interval prolongation (QTcF \> 470 ms for women or QTcF \> 450 ms for men);
• 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.

Sponsors & Collaborators

• Hainan Cancer Hospital: lead
• Frontiergate Biopharm（Hainan） Co., LTD: collaborator

Study Sites (1)

Hainan Cancer Hospital

Haikou, Hainan, 570311, China

RECRUITING

Study Officials

• HAIFENG LIN

  Hainan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

HAIFENG LIN

CONTACT

+86-13322060949; 13322060949@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 16, 2026
• Study Start: December 6, 2025
• Primary Completion (Estimated): December 6, 2027
• Study Completion (Estimated): June 6, 2028
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 6 months after publication and ending 5 years following publication.
• Access Criteria: Access will be granted to researchers with a sound scientific proposal after review and approval, and with a signed data use agreement.

Locations

CN (1)