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Nebulized Inhalation of Recombinant Human p53 Adenovirus Injection for Treatment of Multiple Ground-Glass Lung Nodules: A Single-Arm Clinical Study

NCT07150416 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-09-02

No results posted yet for this study

Summary

This study aims to evaluate the safety and efficacy of nebulized inhalation of Recombinant Human Ad-p53 Injection (Gendicine®) for the treatment of multiple ground-glass lung nodules. This is a single-arm, open-label clinical study conducted at The First Affiliated Hospital of Guangzhou Medical University in China. We plan to enroll approximately 38 patients who have been diagnosed with multiple ground-glass nodules. All participants in this study will receive the nebulized Gendicine® treatment. After the treatment, we will monitor changes in the nodules through regular chest CT scans and record any potential treatment-related reactions to determine if this novel therapy is safe and effective. This study has been approved by the hospital's Ethics Committee.

Conditions

  • Multiple Pulmonary Ground-Glass Nodules
  • Lung Neoplasms
  • Precancerous Conditions

Interventions

DRUG

Recombinant Human Ad-p53 Injection

A replication-deficient recombinant human type 5 adenovirus vector encoding the human wild-type p53 tumor suppressor gene. For this study, it will be administered via nebulized inhalation.

Sponsors & Collaborators

  • Shenzhen SiBiono GeneTech Co.,Ltd

    collaborator INDUSTRY

  • The First Affiliated Hospital of Guangzhou Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2026-12-01
Completion
2027-02-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07150416 on ClinicalTrials.gov