Study on N-803 and PD-L1 t-haNK Combined with Bevacizumab for Recurrent or Worsening Glioblastoma

Sponsor: ImmunityBio, Inc.

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06061809

Provider View

This clinical trial is testing a new combination of treatments, including N-803, PD-L1 t-haNK, and Bevacizumab, to see if they are safe and effective for patients with glioblastoma that has returned or is getting worse.

Patient Parameters

Program Overview

This study aims to evaluate the safety and effectiveness of a new treatment combination for glioblastoma, a type of brain cancer that has come back or is progressing. Participants will receive N-803 under the skin, PD-L1 t-haNK through a vein, and Bevacizumab through a vein. The treatment will be given in cycles of 28 days, up to a maximum of 76 weeks. Treatment will continue unless there are severe side effects, the patient chooses to stop, or the cancer worsens. Participants will be monitored every 12 weeks for the first two years, then annually.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Able to understand and sign a consent form.
  • Have a confirmed diagnosis of glioblastoma that has worsened after initial treatment.
  • Disease progression confirmed by MRI or biopsy.
  • Previously treated with radiotherapy and temozolomide, and at least 28 days since last treatment.
  • Recovered from previous treatment side effects to a mild level.
  • Expected to live more than 12 weeks.
  • Have a Karnofsky Performance Status of 70 or higher, indicating ability to care for oneself.
  • Able to attend study visits and follow-up.
  • Agree to use effective birth control if of childbearing potential.
  • Surgical wounds from brain surgery must be healed for at least 28 days before starting treatment.

Exclusion Criteria

  • Have a serious uncontrolled disease that could interfere with the study treatment.
  • Previously treated with Bevacizumab or similar drugs for glioblastoma.
  • On long-term high-dose steroids.
  • Recent surgery or unhealed surgical wounds.
  • History of serious bleeding or brain bleeding.
  • Recent coughing up blood.
  • On blood thinners.
  • Have a bleeding disorder.
  • Have an autoimmune disease needing treatment in the last 5 years.
  • Have had an organ transplant.
  • Have active inflammatory bowel disease.
  • Need oxygen therapy due to breathing problems.
  • Weigh 40 kg (88 lbs) or less.
  • Have poor organ function based on specific blood tests.
  • Have significant heart disease or recent heart attack.
  • Have serious heart rhythm problems.
  • Allergic to study medications.
  • Participated in another drug study within 28 days.
  • Unable or unwilling to follow study requirements.
  • Pregnant or breastfeeding women.

Get This Program In Your Inbox

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