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

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorPeking University Shenzhen Hospital

About this trial

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 criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • CAR-DC treatment

Treatment groups

10 Participants
are divided into 1 treatment group