Phase 2 Brain Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who were between 20 and 75 years old at the time of their brain tumor surgery.
• People who have been newly diagnosed with a single, primary Grade IV glioblastoma (a specific type of aggressive brain tumor) that is not located in the brainstem or cerebellum, and who are scheduled for or have had surgery to remove it.
• People whose tumor was removed using a navigation-guided surgical technique, without any implants (such as chemotherapy wafers) being placed in the brain during surgery.
• People who have only one glioblastoma tumor.
• People who are able to understand and sign the consent documents for the study.
• People whose life expectancy is expected to be more than 12 weeks, as assessed by the treating doctor.
• People who have stable vital signs and a functional ability score of 70 or above (this is a standard medical scale used to measure how well a person can carry out daily activities — confirm with trial site).
• People whose kidneys are working well enough, based on blood test results (confirm with trial site for specific values).
• People whose liver is working well enough, based on blood test results (confirm with trial site for specific values).
• People whose blood clotting function falls within an acceptable range, based on blood tests (confirm with trial site for specific values).
• People whose blood cell counts — including white blood cells, red blood cells, platelets, and infection-fighting cells — are at acceptable levels before treatment begins.
• People who are willing to use reliable contraception (birth control), as described in the trial protocol, from at least one month before screening until at least six months after the last dose of the trial treatment. This applies to both men and women who are capable of having children. Acceptable methods include full abstinence (as a consistent lifestyle choice), surgical sterilisation, or a combination of two approved contraceptive methods such as hormonal contraception, an intrauterine device, or barrier methods with spermicide.
• People who agree to follow the treatment plan set out in the study.
• People whose tumor tissue has been confirmed by laboratory testing to be a specific type of glioblastoma (IDH-1 wild-type), and who are willing to undergo a blood cell collection procedure at the screening visit.
• People whose tumor tissue shows a specific immune cell marker pattern (a low PD-1+/CD8+ ratio below 0.21 — confirm with trial site for what this means in practice).
• People whose post-surgery brain scan (taken within two days of the operation) shows that less than 25% of the original tumor area remains, as assessed by the surgical or radiology team.

Who may not be able to join:

• People who have more than one glioblastoma tumor.
• People who have taken part in another clinical trial within the four weeks before pre-screening.
• People with a known or suspected allergy to the trial treatment (ADCV01) or its ingredients.
• People who have had a serious allergic reaction (such as anaphylaxis, severe skin reactions, or hives) to dacarbazine, temozolomide, or bevacizumab — medications related to the trial treatment.
• People with an active infectious illness, active heart disease, a history of heart attack in the past six months, or uncontrolled high blood pressure.
• People with a significantly weakened immune system (for reasons other than steroid use), a positive HIV test, or who require immune-suppressing medications.
• People with active rheumatic disease, connective tissue disease, or an active autoimmune condition, or a known history of an autoimmune neurological condition (such as Guillain-Barré syndrome). People with vitiligo, type 1 diabetes, or autoimmune-related thyroid conditions that are managed only with hormone replacement may still be considered eligible (confirm with trial site).
• People with psoriasis that requires systemic (whole-body) treatment, or conditions likely to flare up when triggered externally.
• People with certain active infections including syphilis, active hepatitis B, hepatitis C (except carriers), HTLV-I/II, CMV, or any condition associated with an increased risk of certain rare brain diseases such as Creutzfeldt-Jakob disease.
• People with a history of bleeding disorders or recurring blood clots.
• People with medical, social, or psychological factors that would make it difficult to follow the study plan.
• People who are currently breastfeeding, pregnant, or planning to become pregnant.
• People who are unable to have an MRI scan for any reason.
• People who have had another cancer (other than glioma) that has not been stable for the past five years.
• People considered unsuitable for the trial by the treating doctor, for any reason.
• People whose tumor tissue shows a high PD-1+/CD8+ ratio (0.21 or above) at the screening stage.
• People whose tumor tissue shows a mutant IDH-1 result (a specific genetic finding — confirm with trial site).
• People whose post-surgery scans show that more than 25% of the original tumor remains.

Important: Always verify eligibility with the trial site directly before applying.