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

NCT07504445 | Recruiting Early Phase 1 DMC

• 1 other identifier: 2024-164 (Research) -02
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Advanced Solid Tumors

Keywords

CAR-DC; Advanced solid tumor

Outcome Measures

Primary Outcomes (3)

• To evaluate the objective response rate (ORR) of CAR-DC therapy

  The ORR is evaluated according to Response Evaluation Criteria in Solid Tumours 1.1 (RECIST1.1) .

  2 years

• To evaluate the disease control rate (DCR) of CAR-DC therapy

  The DCR is evaluated according to RECIST1.1 criteria.

  2 years

• The quality of life assessment of CAR-DC therapy

  The quality of life is evaluated according to the Eastern Cooperative Oncology Group (ECOG).

  2 years

Secondary Outcomes (3)

• To evaluate the cytokine release syndrome (CRS) of CAR-DC therapy

  2 years

• To evaluate the neurotoxicity of CAR-DC therapy

  2 years

• To evaluate the survival time of CAR-DC in patient peripheral blood

  2 years

Study Arms (1)

treatment

EXPERIMENTAL

The patients will be treated with CAR-DC infusion.

Biological: CAR-DC treatment

Interventions

CAR-DC treatment BIOLOGICAL

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

treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Peking University Shenzhen Hospital: lead

Study Sites (1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, 518036, China

RECRUITING

Central Study Contacts

Chen Junhui, professor

CONTACT

+86 138 2316 1919; chenjhpush@126.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: March 31, 2026
• Study Start: April 3, 2026
• Primary Completion (Estimated): April 3, 2028
• Study Completion (Estimated): April 3, 2028
• Last Updated: March 31, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

CN (1)