RecruitingPhase 1NCT06773481

BC008-1A Injection for Recurrent CNS WHO G4 Glioma

A Phase I Clinical Study to Evaluate the Safety and Preliminary Efficacy of BC008-1A Injection in Subjects With Recurrent CNS WHO Grade 4 Glioma.


Sponsor

Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd.

Enrollment

40 participants

Start Date

Apr 7, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called BC008-1A, which targets a protein called TIGIT on immune cells, in combination with a PD-1 immunotherapy drug for people with grade 4 brain cancer (glioma) that has come back after standard treatment. **You may be eligible if...** - You are 18 or older with confirmed grade 4 brain cancer (glioma) that has returned after standard treatment - Your cancer progression was confirmed by MRI using standard criteria (RANO) - You are not currently a candidate for further surgery - You have a life expectancy of at least 12 weeks - Your general health and organ function are adequate **You may NOT be eligible if...** - You have previously received anti-TIGIT, PD-1, PD-L1, or CTLA-4 drugs (immune checkpoint inhibitors) - You have another active cancer requiring treatment (excluding certain skin and cervical cancers treated previously) - You have an active or historical autoimmune disease - You have active, uncontrolled brain swelling or neurological symptoms requiring high-dose steroids - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALBC008-1A

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

BIOLOGICALBC008-1A

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


Locations(1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

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NCT06773481


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