Study on the Safety and Effectiveness of CTX-009 With or Without CTX-471 for Recurrent Glioblastoma
Sponsor: Washington University School of Medicine
ClinicalTrials ID:NCT07392957
This clinical trial is testing the safety and effectiveness of a new treatment, CTX-009, alone or combined with CTX-471, for patients with glioblastoma that has returned after initial treatment. The study aims to see if these treatments can better control the tumor and extend patients' lives.
Patient Parameters
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Program Overview
This study is exploring a new treatment approach for patients with recurrent glioblastoma, a type of brain cancer. Researchers are testing CTX-009 by itself and in combination with another drug, CTX-471, to see if they can improve tumor control and help patients live longer. CTX-009 works by targeting mechanisms that help the tumor resist other treatments, while CTX-471 aims to boost the immune system's response to the cancer. The combination of these drugs may enhance their effects on the tumor environment.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with recurrent glioblastoma, a type of brain cancer, after standard treatments like radiation and chemotherapy.
- No more than two recurrences of the cancer.
- At least 18 years old.
- Able to perform daily activities with a performance status of 60% or higher.
- Have good bone marrow and organ function based on specific blood test results.
- Women and men must agree to use effective birth control during the study and for four months after.
- Must have recovered from any side effects of previous cancer treatments to a mild level.
- Stable or decreasing doses of steroids and anti-seizure medications before starting the study drugs.
- Able to understand and sign a consent form to participate in the study.
Exclusion Criteria
- Have not responded to previous anti-VEGF-A therapy or had significant side effects from it.
- Have had recent cancer treatments, including certain drugs or therapies, within a specified time before starting the study.
- Use of certain medications like aspirin or anticoagulants shortly before starting the study drugs.
- History of certain bleeding or gastrointestinal conditions.
- History of serious cardiovascular diseases in the past five years.
- Have had significant vascular diseases recently.
- For Arm 2: Previous treatment with specific immune-oncology therapies.
- For Arm 2: Recent use of systemic non-steroidal immunosuppressive agents.
- Have had organ or cell transplants.
- For Arm 2: Recent live vaccinations.
- Have other cancers that could interfere with the study.
- Allergic reactions to similar drugs as CTX-009 or CTX-471.
- Uncontrolled seizure disorder or other serious illnesses.
- Pregnant or breastfeeding women.
- HIV-positive patients not on effective treatment.
- Active hepatitis B or C infections unless controlled or cured.
Locations
| FACILITY | ZIP | CITY | STATE |
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| Washington University School of Medicine | 63110 | St Louis | Missouri |
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