Targeted activated dendritic cell plus CAR‑T therapy for advanced solid cancers

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

This trial will try combining activated dendritic cells with CAR‑T cells to see if the treatment is safe and helps adults with advanced solid tumors that express Claudin 18.2, GCC, TROP2, or PSMA.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Hainan Cancer Hospital (other)
• Drugs / interventions: CAR-T, chemotherapy
• Locations: 1 site (Haikou, Hainan)
• Trial ID: NCT07475182 on ClinicalTrials.gov

What this trial studies

This is an open‑label, single‑arm early‑phase 1 trial combining targeted activated dendritic cells (DCs) with targeted CAR‑T cells in patients with advanced solid tumors. Patients must have tumor tissue positive for one of the specified targets and at least one measurable lesion per RECIST 1.1, and will undergo PBMC collection for cell manufacturing. The approach aims to modulate the tumor immune microenvironment with activated DCs to break down immunosuppression and enable deeper CAR‑T cell penetration and persistence. The primary focus is safety with collection of preliminary efficacy signals at a single site in Haikou, Hainan.

Who should consider this trial

Good fit: Ideal candidates are adults 18–75 years old with pathologically confirmed advanced solid tumors, at least one RECIST‑measurable lesion, tumor IHC expression ≥2+ in ≥40% of cells for Claudin 18.2, GCC, TROP2, or PSMA, ECOG 0–1, life expectancy ≥3 months, and eligible for PBMC collection after failing or lacking standard second‑line options.

Not a fit: Patients are unlikely to benefit if their tumors do not express the required targets, if they have ECOG >1 or short life expectancy, or if they cannot safely undergo PBMC collection or cell infusion.

Why it matters

Potential benefit: If successful, the combination could improve CAR‑T cell penetration into solid tumors and produce more durable tumor control for patients with target‑positive cancers.

How similar studies have performed: Similar combination strategies of modifying the tumor microenvironment plus CAR‑T therapy are largely experimental with limited clinical success so far, though preclinical data show promise.

Eligibility criteria

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.

Where this trial is running

Haikou, Hainan

• Hainan Cancer Hospital — Haikou, Hainan, China (RECRUITING)

Study contacts

• Principal investigator: HAIFENG LIN — Hainan Cancer Hospital
• Study coordinator: HAIFENG LIN

Conditions: Advanced Solid Cancers