CAR-DC treatment for advanced solid tumors that express specific target proteins

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

This study will test whether two intravenous infusions of engineered CAR-DC immune cells are safe and can shrink advanced solid tumors that express one of several target antigens.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Peking University Shenzhen Hospital (Academic / other)
• Drugs / interventions: chimeric antigen receptor
• Locations: 1 site (Shenzhen, Guangdong)
• Trial ID: NCT07504445 on ClinicalTrials.gov

What this trial studies

This is a prospective, open-label, single-arm early-phase 1 trial enrolling up to 10 patients with advanced solid tumors that are positive for one of seven target antigens (EphA2, CLDN18.2, Trop2, HER2, GCC, GPC3, or CEA). Participants receive two intravenous infusions of 30 million CAR-DC cells spaced 14 days apart and are followed for safety and preliminary efficacy outcomes for up to one to two years after treatment. The primary focus is safety and tolerability, with secondary measures including imaging-based tumor response, biomarker changes, and clinical status. Eligible patients must have measurable disease, IHC-confirmed antigen expression (≥2+), ECOG 0–2, and have failed or been intolerant of standard therapies.

Who should consider this trial

Good fit: Ideal candidates are adults 18–70 with measurable, advanced (stage III–IV) solid tumors that show ≥2+ expression by IHC of one of the listed antigens and who have exhausted or cannot tolerate standard treatments and have ECOG 0–2.

Not a fit: Patients without the required antigen expression, with poor organ or bone marrow function, an expected survival under three months, or who cannot attend the single study site are unlikely to benefit.

Why it matters

Potential benefit: If successful, CAR-DC could restore immune activity in the tumor microenvironment and lead to tumor shrinkage in patients whose cancers express the targeted antigens.

How similar studies have performed: CAR-DC approaches are novel with limited clinical data—while CAR-T therapies have shown success in blood cancers, engineered dendritic cell strategies for solid tumors are largely unproven and remain experimental.

Eligibility criteria

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.

Where this trial is running

Shenzhen, Guangdong

• Peking University Shenzhen Hospital — Shenzhen, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Chen Junhui, professor

Conditions Advanced Solid Tumors; CAR-DC; Advanced solid tumor