Safety and Efficacy of NRG-103 Injection in the Treatment of Recurrent Glioblastoma Patients

NCT06757153 | Recruiting Early Phase 1 DMC

• 2 other identifiers: NRG103001ChiCTR2400093705
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if NRG103 works to treat recurrent GBM in adults. It will also learn about the safety of NRG103. The main questions it aims to answer are: Does NRG103 prolong overall survival or disease-free survival in patients with GBM? What medical problems do participants have when receiving NRG103 treatment? Researchers will give patients with NRG103 to see if NRG103 works to treat recurrent GBM. Participants will: Receive NRG103 twice in 14 days Visit the clinic once every 2 weeks for checkups and tests Keep a diary of their symptoms

Conditions

Glioblastoma (GBM)

Keywords

Glioblastoma;Oncolytic virus;NRG103;Trans-differentiation;

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  The participants will be followed until disease progression by RANO criteria

  6 months after NRG-103 treatment

Secondary Outcomes (1)

• Overall survival

  12 months after NRG-103 treatment

Study Arms (1)

NRG-103

EXPERIMENTAL

NRG-103 is an innovative gene therapy drug developed based on the in situ trans-differentiation technology. Through multiple mutation modifications of the adenovirus genome, it can enhance the specific recognition and killing effect of oncolytic virus on GBM tumor cells without being limited by tumor gene phenotype, and regulate the immune microenvironment to induce stronger anti-tumor immune response. In addition, the two transcription factors expressed on NRG-103 can efficiently transdifferentiate residual GBM tumor cells into non tumor like neuronal cells, in order to achieve the goal of delaying tumor recurrence and long-term survival.

Drug: NRG-103

Interventions

NRG-103 DRUG

NRG-103 is an oncolytic virus, which can kill GBM cells via three manners.

NRG-103

Eligibility Criteria

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

You may qualify if:

• Age≥18 years.
• Patients must have histologically or cytologically confirmed glioblastoma(WHO 2021).
• Patients have experienced recurrence (RANO 2.0) after previous anti-tumor treatments, including the recurrent tumor has been surgically removed and an Ommaya reservoir has been placed inside the tumor cavity.
• The relevant adverse reactions from the previous treatment have been restored to ≤1 level(NCI-CTCAE v5.0).
• Karnofsky Performance Score≥70.
• Adequate bone marrow reserve: White blood cell count\>2.0 × 109/L, neutrophil count\>1.0 × 109/L, platelet count\>100 × 109/L, international normalized ratio ≤1.5 times ULN, and activated partial thromboplastin time≤1.5 times ULN.
• Normal heart, renal and liver function.
• Effective method of contraception for patients and their partners.
• Written informed consent.

You may not qualify if:

• Allergy to the components of the test drug and contrast agent.
• Unable to undergo imaging examinations required for the research.
• A history of cell therapy, gene therapy, or oncolytic virus therapy.
• Undergoing other clinical trials.
• A history of anti-tumor vaccines or other immunomodulatory drugs with 4 weeks.
• A history of other type of malignant tumors.
• Unexplained fever.
• A history of autoimmune disease.
• A history of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation.
• Active hepatitis B, or hepatitis C.
• Severe heart disease (NYHA III or IV), or poorly controlled diabetes.
• Two or more GBM lesions.
• GBM lesion located in the brainstem, cerebellum, posterior fossa, or spinal cord, as well as leptomeningeal diseases.
• A history of diffuse subarachnoid and subarachnoid diseases.
• GBM lesion invades the ventricular wall or tumor cavity communicates with the ventricle after surgery.

Sponsors & Collaborators

• Zhongnan Hospital: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430000, China

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Zhiqiang Li

  Zhongnan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiqiang Li

CONTACT

+86-18907123005; lizhiqiang@whu.edu.cn

Feng Tang

CONTACT

+86-18326163693; zntang@whu.edu.cn

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: Principal Investigator

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: January 3, 2025
• Study Start: December 19, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)