Actively Recruiting

Early Phase 1
Age: 18Years - 70Years
All Genders
NCT07504445

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

Led by Peking University Shenzhen Hospital · Updated on 2026-03-31

10

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18-70 years, any gender
  • Diagnosed with advanced solid tumors positive for EphA2, Claudin18.2, TROP2, HER2, GCC, GPC-3, or CEA
  • Positive antigen expression confirmed by immunohistochemical analysis with intensity 2+
  • Failed or intolerant to all standard treatments
  • Measurable tumor lesions visible on imaging
  • ECOG performance status score of 0 to 2
  • Expected survival time longer than 3 months
  • Good organ function and bone marrow reserve, including:
    • Absolute neutrophil count 1.0 x 10^9/L, platelet count 50 x 10^9/L, hemoglobin 80 g/L, no recent blood transfusions or growth factor treatments within 14 days
    • Kidney function with creatinine 1.5 x ULN or creatinine clearance 50 mL/min, urine output 10 mL/h
    • Coagulation tests (INR and APTT) 1.5 x ULN, excluding those on therapeutic anticoagulants
    • Blood oxygen saturation 90%, negative fecal occult blood test
  • Willing to provide informed consent and comply with study visits and procedures
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Unable to guarantee effective contraception for one year after enrollment
  • Brain metastases causing significant psychiatric or neurological symptoms
  • Serious heart diseases such as arrhythmia
  • Autoimmune diseases
  • Active bacterial, fungal, or other infections
  • Infectious diseases including HIV, syphilis, tuberculosis, or viral hepatitis
  • Currently using medications such as glucocorticoids, thrombolytic agents, or antipsychotics
  • Considered unsuitable for the trial by investigators for other reasons

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China, 518036

Actively Recruiting

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Research Team

C

Chen Junhui, professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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