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Clinical Trials in China / NCT07504445
Starting soon Phase EARLY_PHASE1

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

NCT07504445 · tracked via the Priya Life Science China tracker
Sponsor
Peking University Shenzhen Hospital
Phase
Phase EARLY_PHASE1
Started
2026-06-10
Last updated
2026-06-03

Condition(s) studied

Advanced Solid Tumors

Investigational drug(s) / intervention(s)

CAR-DC treatment

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

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking University Shenzhen Hospital Shenzhen Guangdong

More Peking University Shenzhen Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07504445 on ClinicalTrials.gov ↗ ← All trials in China