Expanded Access Program for GBM Subjects

NCT ID: NCT06676891

Last Updated: 2025-01-08

Basic Information

• Recruitment Status: AVAILABLE
• Study Classification: EXPANDED_ACCESS

Brief Summary

This small-size patient population expanded access program is to provide access to investigational product RZ-001 for up to around 4 patients with human telomerase reverse transcriptase(hTERT)-positive Glioblastoma (GBM) who are not eligible to participate in the RZ-001-201 clinical study or in any other study involving the use of RZ-001

Detailed Description

This expanded access protocol provides expanded access to RZ-001 to patients with glioblastoma. After provision of written informed consent, subjects will be evaluated for eligibility during the Screening period, a period of 28 days prior to the RZ-001 administration on Day 1. Subjects will then undergo treatment, 8 weeks of follow-up, and bimonthly or quarterly (after 6 months from RZ-001 administration) survival follow-up.

Conditions

Glioblastoma

Interventions

RZ-001

Participants will receive a single intracerebral injection of RZ-001, Recombinant adenovirus harboring the modified ribozyme construct with HSV-tk as a therapeutic transgene

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Males and females legally considered to be adults in the country in which they are participating in the study.

2. Histologically-confirmed Grade 4 astrocytoma, GBM, per The 2021 WHO Classification of central nervous system (CNS) Tumors.

3. Recurrent GBM with radiographic evidence of the PD (progressive disease) which contains measurable disease (≥ 1 cm bidirectional diameters) by contrast-enhancement on MRI, as defined by the mRANO (modified Response Assessment in Neuro-Oncology) criteria. Only localized unifocal or multifocal recurrence is allowed, while other type of recurrences such as intraventricular, diffuse recurrence are not allowed.

Exclusion Criteria

1. Diagnosis of other malignant tumors within 5 years prior to RZ-001 administration.

2. Have received chemotherapy within 4 weeks, and/or immunomodulatory therapy, immunotherapy, antibody therapy, gene vector therapy, vaccine therapy, and/or matrix metalloprotease inhibitor(s) within 3 months from Screening.

3. Have received radiotherapy within 12 weeks from Screening.

4. Have extracranial metastases of the tumor cells.

5. The subject is eligible for participation in any ongoing clinical study with RZ-001, or has already received RZ-001 in the past.

6. The subject is being transferred from an ongoing clinical study for which they are still eligible.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rznomics, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Brigham & Women's Hospital

Boston, Massachusetts, United States

Site Status: AVAILABLE

Countries

United States

Central Contacts

Rznomics

Role: CONTACT

rznomics@rznomics.com

+82-31-706-8730

Other Identifiers

RZ-001-201-EAP

Identifier Type: -

Identifier Source: org_study_id