Clinical Study on the Efficacy and Safety of CAR-DC in the Treatment of Advanced Solid Tumors
Starting soon · Early Phase 1
Conditions studied: Advanced Solid Tumors
In brief
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).
Key facts
- Study ID
- NCT07504445
- Run by
- Peking University Shenzhen Hospital
- People needed
- 10
- Starts
- 2026-06-10
- Expected to finish
- 2028-04-03
- Last updated by the study team
- 2026-06-03
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Aged 18-70, regardless of gender;
- 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).
- 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+;
- Failed response to standard treatment or unwilling/intolerant to all standard treatment regimens;
- Imaging indicates measurable tumor lesions;
- ECOG PS score: 0-2;
- Expected survival time is greater than 3 months;
- Maintaining good organ function and bone marrow reserve capacity:
- 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;
- 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;
- Coagulation: International Normalized Ratio (INR) ≤ 1.5 × ULN, and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN (excluding those receiving therapeutic anticoagulants);
- Other: Blood oxygen saturation ≥ 90%, negative fecal occult blood test, etc.
- 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.
You may not qualify if…
- Pregnant and lactating women; (The pregnancy test results are included in the CRF)
- The patient can not guarantee effective contraceptive measures (such as condoms or birth control pills) within one year after enrollment;
- Patients with brain metastases exhibiting significant psychiatric and neurological symptoms;
- Serious heart diseases such as arrhythmia;
- Autoimmune diseases;
- Active bacterial, fungal, and other infections;
- Infectious diseases: such as HIV, syphilis, tuberculosis, viral hepatitis and other diseases;
- Patients are receiving medications such as glucocorticoids, thrombolytic drugs, and antipsychotic drugs;
- Patients are believed not suitable for this clinical trial for other reasons by investigators.
Where it is running
- Peking University Shenzhen Hospital — Shenzhen, Guangdong, China
Full record on ClinicalTrials.gov
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