NCT06763965

Evaluating the Safety and Efficacy of BioTTT001 in Patients With Recurrent/Progressive High-grade Glioma.

A Phase Ib/Ⅱ Clinical Study to Evaluate the Safety, Tolerability, Biodistribution Characteristics and Preliminary Efficacy of Recombinant Human nsIL12 Oncolytic Adenovirus Injection With Recurrent/Progressive High-grade Glioma.

• Status: Enrolling By Invitation
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Beijing Bio-Targeting Therapeutics Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-arm, open-label, dose-escalation and dose-expanding Phase Ⅰb/Ⅱ clinical study to evaluate the safety, tolerability, biodistribution characteristics and preliminary efficacy of recombinant human nsIL12 oncolytic adenovirus injection (BioTTT001) in patients with recurrent/progressive high-grade glioma.

Detailed description

Phase Ⅰb Dose Escalation Study:Three dose groups were established in the dose escalation phase, namely 1.0×10\^10 VP, 5.0×10\^10 VP and 2.5×10\^11 VP. The traditional "3+3" dose escalation method was used for dose escalation, with at least 3 subjects enrolled in each dose group, and each subject received only one corresponding dose until the MTD and/or RP2D were determined.It is planned to enroll 12\~18 subjects, and the final sample size of enrollment depends on the number of DLT, the number of dose groups that are escalated before the DLT is observed, and the determination of the MTD. Phase Ⅱ Dose Expansion Study:In this phase, one dose group was selected for a dose expansion study to further evaluate the efficacy and safety of BioTTT001 in patients with recurrent/progressive high-grade glioma.It is planned to select 1 dosage that may be used for phase Ⅰ clinical research to expand enrollment, and it is planned to enroll 10\~30 subjects.

Conditions

• Recurrent High-grade Glioma

Interventions

Type	Name	Description
BIOLOGICAL	BioTTT001 injection	BioTTT001 is administered as a multiple Intratumoral injection. The dose groups to be infusion were 1.0×10\^10 viral particle (VP) ,5.0×10\^10 VP and 2.5×10\^11 VP based on the 3+3 dose escalation principle.

Timeline

• Start date: 2024-11-26
• Primary completion: 2027-07-31
• Completion: 2027-07-31
• First posted: 2025-01-08
• Last updated: 2026-03-23

Locations

1 site across 1 country: China