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

StatusEnrolling by Invitation
PhasePhase 1/2
Started2024-11-26
View on ClinicalTrials.gov ↗

Amendment history

2026-03-19
Study Identification, Study Status, Eligibility, Contacts/Locations v2
Eligibility criteria+3,095 characters
Inclusion Criteria: AgeAged 18-70 years oldor (includingolder, the critical value),both male orand female are eligible; Patients with high-grade glioma who have recurred/progress [...] er ≥ CTCAE grade 2 bleeding event within the past 6 months; Subjects who have received systemic corticosteroids (>10 mg/day of prednisone or equivalent) or other immunosuppressants within 14 days prior to the first dose; except in the following cases: use of topical, ocular, intra-articular, intranasal, and inhaled corticosteroid treatments; short-term use o [...] Patients with brain herniation syndrome; Known alcohol or drug [...] [...]
Study sitesdetails revised at 1 of 1 site
Study title-17 characters
A Clinical Study Evaluating the Safety and Efficacy of BioTTT001 in Patients With Recurrent/Progressive High-grade Glioma.
2025-11-25
Study Identification, Study Status, Oversight, IPDSharing v1
Primary completion date2026-08-26→2027-07-31
Completion date2026-08-26→2027-07-31
Study titlerevised
A Clinical Study Evaluating the Safety and Efficacy of BioTTT001 in Patients withWith Recurrent/progressiveProgressive High-grade Glioma.
2025-01-02
Original filing
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.
Trial Details
NCT Number NCT06763965
Lead Sponsor Beijing Bio-Targeting Therapeutics Technology Co., Ltd
Conditions Recurrent High-grade Glioma
Enrollment 30 participants
Start Date 2024-11-26
Primary Completion 2027-07-31 (estimated)
Study Completion 2027-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-23