NCT06676891

Expanded Access Program for GBM Subjects

Expanded Access to RZ-001 in Combination with Valganciclovir in the Treatment of Subjects with Glioblastoma

• Status: Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Rznomics, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	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

Timeline

• First posted: 2024-11-06
• Last updated: 2025-01-08

Locations

1 site across 1 country: United States