Clinical Study on the Safety and Efficacy of TS-2021 in the Treatment of Recurrent Malignant Glioma

A Clinical Study of the Safety and Efficacy of Third-generation Oncolytic TS-2021 in the Treatment of Recurrent Malignant Gliomas

The goal of this clinical trial is to evaluate the safety and efficacy of oncolytic virus TS-2021 in the treatment of recurrent malignant glioma.About 30 eligible participants with recurrent malignant glioma will :

• Be intratumoral injected the TS-2021 oncolytic virus to study its safety and efficacy.
• Be followed for 1 year after the injection to complete imaging studies, neurological function tests, and report adverse events.

Using the data obtained during the follow-up period, researchers will conduct statistical analyses and evaluate the safety and efficacy of oncolytic virus TS-2021.

Study Overview

• Status: Recruiting
• Conditions: Glioblastoma Multiforme; Glioma, Malignant
• Intervention / Treatment: Biological: TS-2021

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Fusheng Liu, MD,PhD; Phone Number: 861059975630; Email: liufushengs@hotmail.com
• Study Contact Backup: Name: Junwen Zhang, PhD; Phone Number: 861059975630; Email: jewzhang@hotmail.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Recruiting
      • Beijing Tiantan Hospital
      • Contact: Fusheng Liu, MD,PhD; Phone Number: 861059975630; Email: liufushengs@hotmail.com
      • Contact: Junwen Zhang, PhD; Phone Number: 861059975630; Email: jewzhang@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The patient signed the informed consent voluntarily.
• Age ≥18 years and ≤65 years, male or female.
• After the initial surgery, the imaging showed that the tumor was completely removed, followed by conventional radiotherapy or (and) chemotherapy, and no recurrence was observed within two months after the end of radiotherapy. The patient had a recurrence of supratentorial high-grade glioma. The pathological diagnosis was glioblastoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligodendro-astrocytoma, or subtentorial astrocytoma recurrence.
• After conventional surgery, radiotherapy (or) chemotherapy was performed, and there was no recurrence at the primary site of the tumor, but there was tumor recurrence at the distant site.
• With PET/MRS, tumor recurrence was considered, and the enhanced lesion diameter was greater than 1cm, but less than 3cm.
• KPS score ≥70 before treatment.
• Normal bone marrow reserve function and normal liver and kidney function: Neutrophil absolute value ≥ 1,500/mm3, hemoglobin ≥10 g/dL, platelet count ≥100,000/mm3, total bilirubin level ≤1.5×ULN, glutamic pyruvic transaminase/glutamic oxalacetic transaminase ≤ 2.5× ULN, serum creatinine ≤1.5×ULN, The heart function was normal and the follow-up compliance was good.
• Women of childbearing age (15 to 49 years) must undergo a pregnancy test within 7 days before starting treatment and the result is negative; Fertile men and women must consent to the use of effective contraception to ensure that they do not become pregnant during the study period and for 3 months after stopping treatment.

Exclusion Criteria:

• Pregnant or lactating patients.
• Patients with encephalitis disease, multiple sclerosis, or other CNS (Central Nervous System) infection.
• Patients with a history of organ transplantation or waiting for organ transplantation.
• Patients with uncontrolled infectious diseases or other serious diseases, such as HIV positive.
• Patients with any unstable systemic illness (including active infection, uncontrolled hypertension, unstable angina pectoris, angina pectoris beginning within the last 3 months, congestive heart failure, myocardial infarction occurring within 12 months before enrollment, severe arrhythmia requiring medical treatment, liver or kidney failure, etc.)
• Patients with systemic autoimmune diseases or immunodeficiency diseases.
• Patients with severe allergic constitution.
• Patients with chronic diseases requiring long-term treatment with immune agents or glucocorticoids.
• Patients with mental disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TS-2021; 30 eligible participants with recurrent malignant glioma will be intratumoral injected the TS-2021 oncolytic virus to study its safety and efficacy.	Biological: TS-2021; The participants meeting the criteria will undergo TS-2021 oncolytic virus (5×1011PFU/ml) intratumoral injection using stereotactic technique under MR Localization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of adverse events.	All events with a Grade 3 or above toxicity (defined by the CTCAE v4.0) will be tabulated by event and by relationship to TS-2021.	Up to 8 weeks
Overall survival	The overall survival for each patient receiving TS-2021 will be calculated.	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR) determined by MRI scan review.	Interval tumor size change will be measured.	Up to 12 months
Progression Free Survival.	Time after TS-2021 administration to clinical and radiographic disease progression	Up to 12 months

Collaborators and Investigators

• Sponsor: Beijing Neurosurgical Institute
• Investigators: Study Director: Fusheng Liu, MD,PhD, Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: September 3, 2024
• First Submitted That Met QC Criteria: September 3, 2024
• First Posted (Actual): September 5, 2024

Study Record Updates

• Last Update Posted (Actual): October 31, 2024
• Last Update Submitted That Met QC Criteria: October 29, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Glioblastoma Multiforme; IL-15; Oncolytic Virus; Adenovirus; Ki-67; Glioma, Malignant; TGF-β2
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Astrocytoma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Glioma
• Other Study ID Numbers: 2024-1-1071

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No