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

NCT06763965 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-03-23

No results posted yet for this study

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.

Conditions

  • Recurrent High-grade Glioma

Interventions

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.

Sponsors & Collaborators

  • Beijing Bio-Targeting Therapeutics Technology Co., Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-26
Primary Completion
2027-07-31
Completion
2027-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06763965 on ClinicalTrials.gov