Clinical Study on the Efficacy and Safety of CAR-DC in the Treatment of Advanced Solid Tumors

This is a prospective, open label, single arm clinical trial to evaluate the safety and the preliminary efficacy of chimeric antigen receptor-dendritic cell (CAR-DC) in the treatment of advanced solid tumors positive for one of the following antigens: ephrin type-A receptor 2 (EphA2), claudin-18 isoform 2 (CLDN18.2) , trophoblast cell surface antigen 2 (Trop2), human epidermal growth factor receptor 2 (HER2), guanylyl cyclase-C (GCC), glypican-3 (GPC3) and carcinoembryonic antigen (CEA).

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Biological: CAR-DC treatment

Detailed Description

Dendritic cell (DC) plays a vital role in T cell priming and anti-tumor immune activation. A novel kind of engineered DC, chimeric antigen receptor-dendritic cell (CAR-DC) can reverse the immune suppression in tumor-microenvironment (TME) to enhance anti-tumor therapy. This is a prospective, open label, single arm clinical trial to evaluate the safety and the preliminary efficacy of CAR-DC in the treatment of advanced solid tumors positive for one of the following antigens: ephrin type-A receptor 2 (EphA2), claudin-18 isoform 2 (CLDN18.2) , trophoblast cell surface antigen 2 (Trop2), human epidermal growth factor receptor 2 (HER2), guanylyl cyclase-C (GCC) , glypican-3 (GPC3) AND carcinoembryonic antigen (CEA). A total number of 10 patients will receive two rounds of intravenous infusions of 30 million CAR-DC at an interval of 14 days and receive follow-up visits after the second round of infusion up to 1 or 2 years.

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

Contacts and Locations

• Study Contact: Name: Chen Junhui, professor; Phone Number: +86 138 2316 1919; Email: chenjhpush@126.com

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518036
      • Recruiting
      • Peking University Shenzhen Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Aged 18-70, regardless of gender;
2. Diagnosed as EphA2or Claudin18.2, TROP2, HER2, GCC, GPC-3, CEA positive advanced solid tumors, such as lung cancer, liver cancer, colorectal cancer, gastric cancer, etc; Note: Advanced solid tumors refer to locally advanced (stage III patients) and metastatic advanced (stage IV patients) TNM staging by the American Cancer Society (AJCC).
3. Immunohistochemical analysis of pathological tissue approves positive expression for one of the following antigens, including EphA2, Claudin18.2, TROP2, HER2, GCC, GPC-3 and CEA, with expression intensity ≥ 2+;
4. Failed response to standard treatment or unwilling/intolerant to all standard treatment regimens;
5. Imaging indicates measurable tumor lesions;
6. ECOG PS score: 0-2;
7. Expected survival time is greater than 3 months;

8. Maintaining good organ function and bone marrow reserve capacity:

   1. Bone marrow: Absolute neutrophil count (ANC) ≥ 1.0 × 10^9/L, platelet count ≥ 50 × 10^9/L, hemoglobin ≥ 80 g/L, and no blood transfusion or biological regulator treatments (such as granulocyte colony-stimulating factor, red blood cell growth factor, etc.) within 14 days prior to screening;
   2. Kidney: creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance rate (Ccr) ≥ 50 mL/min (according to the Cockcroft-Gault formula); Urine output>10 mL/h within 16-24 hours;
   3. Coagulation: International Normalized Ratio (INR) ≤ 1.5 × ULN, and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN (excluding those receiving therapeutic anticoagulants);
   4. Other: Blood oxygen saturation ≥ 90%, negative fecal occult blood test, etc.
9. The patient is willing to enroll and signs a written informed consent form, and is able to undergo diagnosis, treatment, and visits according to the protocol.

Exclusion Criteria:

1. Pregnant and lactating women; (The pregnancy test results are included in the CRF)
2. The patient can not guarantee effective contraceptive measures (such as condoms or birth control pills) within one year after enrollment;
3. Patients with brain metastases exhibiting significant psychiatric and neurological symptoms;
4. Serious heart diseases such as arrhythmia;
5. Autoimmune diseases;
6. Active bacterial, fungal, and other infections;
7. Infectious diseases: such as HIV, syphilis, tuberculosis, viral hepatitis and other diseases;
8. Patients are receiving medications such as glucocorticoids, thrombolytic drugs, and antipsychotic drugs;
9. Patients are believed not suitable for this clinical trial for other reasons by investigators.

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: treatment; The patients will be treated with CAR-DC infusion.	Biological: CAR-DC treatment; The patients will receive intravenous injection (iv) of 30 million CAR-DC for two rounds at an interval of 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the objective response rate (ORR) of CAR-DC therapy	The ORR is evaluated according to Response Evaluation Criteria in Solid Tumours 1.1 (RECIST1.1) .	2 years
To evaluate the disease control rate (DCR) of CAR-DC therapy	The DCR is evaluated according to RECIST1.1 criteria.	2 years
The quality of life assessment of CAR-DC therapy	The quality of life is evaluated according to the Eastern Cooperative Oncology Group (ECOG).	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the cytokine release syndrome (CRS) of CAR-DC therapy	The CRS is evaluated according to National Cancer Institute - the Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 (NCI CTCAE5.0).	2 years
To evaluate the neurotoxicity of CAR-DC therapy	Neurotoxicity is evaluated according to NCI CTCAE5.0	2 years
To evaluate the survival time of CAR-DC in patient peripheral blood	The survival time of CAR-DC in patient peripheral blood is analysed by flow cytometry of patient blood samples.	2 years

Collaborators and Investigators

• Sponsor: Peking University Shenzhen Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 3, 2026
• Primary Completion (Estimated): April 3, 2028
• Study Completion (Estimated): April 3, 2028

Study Registration Dates

• First Submitted: January 21, 2025
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): March 31, 2026

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Advanced solid tumor; CAR-DC
• Other Study ID Numbers: 2024-164 (Research) -02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

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