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NCT04952272 Clinical Trial

Intratumor CpG-ODN Injection Boosters Immune Killing Against in Situ Tumor Antigen Release for Advanced Solid Tumors

Lung Cancer Clinical Trial

Official title:
Intratumor CpG-ODN Injection Boosters Immune Killing Against in Situ Tumor Antigen Released by Interventional Approaches for Advanced Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04952272
Other study ID # ZZITCpG-013
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date March 1, 2021
Est. completion date June 30, 2036

Study information
Verified date February 2023
Source Second Affiliated Hospital of Guangzhou Medical University
Contact Zhenfeng Zhang, MD, PhD
Phone +862039195966
Email zhangzhf@gzhmu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To study the safety and clinical effects of intratumor injecting CpG-ODN and in situ release of tumor antigen by interventional ablation or drug-eluting beads to treat advanced solid tumors.

Description:

1. Percutaneous microwave ablation or intratumor injection of drug-eluting beads to destroy cancer cells to release tumor-specific antigens 2. Intratumor injection of type A/C CpG-ODN with or without infusion of CAR-T cells secreting scFv against OX40 3. Assessing side effects and therapeutic efficacy after the combined treatments

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date June 30, 2036
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Solid advanced malignant tumors - Age between18 and 80 years - Life expectancy is greater than three months Exclusion Criteria: - Benign tumor - Life expectancy is less than three months - Serious medical comorbidity - Others

Study Design

Related Conditions & MeSH terms

Intervention

Combination Product:
• CpG-ODN
CAR-T cells secreting scFv against OX40

Locations
Country Name City State
China The Second Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong

Sponsors (2)
Lead Sponsor Collaborator
Second Affiliated Hospital of Guangzhou Medical University Guangdong Zhaotai InVivo Biomedicine Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assessing safety and treatment efficacy on intratumor injection of CpG-ODN and in situ tumor antigen release for advanced tumors Assessing incidence of side effects and primary clinical response of the intratumor injection of CpG-ODN and therpeutical in situ tumor antigen release for advanced tumors, including CR, PR, SD, and PD. up to 36 months
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