Intratumor CpG-ODN Injection Boosters Immune Killing Agai... | NCT04952272

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

NCT04952272

Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Status

Recruiting

Last Update Posted

Jun 26, 2024Actual

Enrollment

50Estimated

Phase

Phase 1

Conditions

Lung Cancer
Hepatocellular Carcinoma
Solid Tumor

Interventions

CpG-ODN

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2021Actual

Primary Completion Date

Jun 30, 2029Estimated

Completion Date

Jun 30, 2036Estimated

First Submitted Date

Jun 27, 2021

First Submission Date that Met QC Criteria

Jun 27, 2021

First Posted Date

Jul 7, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2024

Last Update Posted Date

Jun 26, 2024Actual

Name	Class
Guangdong Zhaotai InVivo Biomedicine Co. Ltd.	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intratumor CpG-ODN Injection	Experimental	CpG-ODN will be Injected into the tumor.	Combination Product: CpG-ODN

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CpG-ODN	Combination Product	CAR-T cells secreting scFv against OX40	Intratumor CpG-ODN Injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhenfeng Zhang, MD, PhD	Contact	+862039195966		zhangzhf@gzhmu.edu.cn
Bingjia He, MD	Contact	+862039195965		464677938@qq.com

Overall Officials

Name	Affiliation	Role
Zhenfeng Zhang, MD, PhD	Second Affiliated Hospital of Guangzhou Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Second Affiliated Hospital of Guangzhou Medical University	Recruiting	Guangzhou	Guangdong	510260	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008175	Lung Neoplasms
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C408982	CPG-oligonucleotide

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided