Study on the Safety and Effectiveness of CTX-009 With or Without CTX-471 for Recurrent Glioblastoma

Sponsor: Washington University School of Medicine

Sponsor score: 40

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

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

FACILITYZIPCITYSTATE
Washington University School of Medicine63110St LouisMissouri

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.