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BC008-1A Injection for Recurrent CNS WHO G4 Glioma

NCT06773481 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-07-09

No results posted yet for this study

Summary

The purpose of this Phase I clinical study is to evaluate the safety, preliminary efficacy and pharmacokinetic characteristics of BC008-1A injection in subjects with recurrent CNS WHO grade 4 glioma. This is a randomized and open-label study, with two dose groups set up, and 10 to 20 subjects will be enrolled in each group.

Conditions

  • Glioma
  • Glioma Tumor Recurrence
  • Glioma, Recurrent High Grade
  • Glioblastomas (GBM)
  • Glioblastoma WHO Grade IV

Interventions

BIOLOGICAL

BC008-1A

Biological: 900 mg BC008-1A will be intravenously injected once every 3 weeks.

BIOLOGICAL

BC008-1A

Biological: 1200 mg BC008-1A will be intravenously injected once every 3 weeks.

Sponsors & Collaborators

  • Beijing Tiantan Hospital

    collaborator OTHER

  • Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-07
Primary Completion
2026-06-30
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT06773481 on ClinicalTrials.gov