N-803 and PD-L1 t-haNK Combined With Bevacizumab for Recurrent or Progressive Glioblastoma

Running, not enrolling · Phase 2

Conditions studied: Glioblastoma

In brief

This study consists of 2 portions. The phase 2 portion is an open-label, single-arm study to evaluate the safety and efficacy of NAI, PD-L1 t-haNK, and bevacizumab combination therapy in participants with recurrent or progressive GBM. The phase 2B portion is an open-label, randomized study to evaluate the efficacy and safety for the following 2 experimental arms in participants with recurrent or progressive GBM: NAI, bevacizumab, and TTFields combination therapy (Arm A) or NAI, PD-L1 t-haNK, bevacizumab, and TTFields combination therapy (Arm B). Phase 2 Treatment for all enrolled participants will consist of repeated cycles of 28 days for a maximum treatment period of 76 weeks (19 cycles) as follows: Every 2 weeks (Days 1 and 15 of a 28-day cycle) Fourteen (14) participants were enrolled in the phase 2 portion of this study as of the date of this v02 protocol. No additional participants will be administered therapy in phase 2. Phase 2B Participants will be randomized 1:1 to 1 of 2 experimental arms (Arm A or Arm B). Treatment for all enrolled participants will consist of repeated 8-week cycles for a maximum treatment period of up to 80 weeks (10 cycles). Experimental Arm (A): Every 2 weeks (Days 1, 15, 29, and 43 of an 8-week cycle) Up to twenty (20) participants will be randomized in phase 2B (up to 10 participants/arm. Duration of Treatment: Participants will receive study treatment for up to 76 weeks during phase 2 (up to 19 repeated 28-day cycles) and for up to 80 weeks (up to 10 repeated 8-week cycles) during phase 2B or until they report unacceptable toxicity (not corrected with dose reduction), withdraw consent, or if the Investigator feels it is no longer in the participant's best interest to continue treatment. Treatment may also be discontinued if the participant has confirmed PD per iRANO, unless the participant is clinically stable and is considered potentially deriving benefit per Investigator's assessment. Duration of Follow-up: Participants who discontinue study treatment should remain in the study for follow-up. Participants should be followed for collection of survival status, posttreatment therapies (phase 2 and phase 2B), and medical history (phase 2B only) every 12 weeks (± 2 weeks) for the first 2 years then yearly thereafter for an additional 3 years. The maximum duration of follow-up is 5 years (260 weeks).

Key facts

Study ID

NCT06061809

Run by

ImmunityBio, Inc.

People needed

34

Starts

2024-08-07

Expected to finish

2030-12-31

Last updated by the study team

2026-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drugs used in this study or that would put the subject at high risk for treatment related complications.
• Prior anticancer treatment of glioblastoma with bevacizumab or other anti-angiogenic treatment.
• Current chronic daily treatment (continuous for > 3 months) with systemic corticosteroids (dose equivalent to or greater than 8 mg/day dexamethasone), excluding inhaled steroids. Short-term steroid use to prevent intravenous (IV) contrast allergic reaction or anaphylaxis in subjects who have known contrast allergies is allowed.
• History of surgery in the past 28 days or with surgical wound not healed.
• History of serious hemorrhage as defined by NCI CTCAE 5.0 grading.
• Evidence of > Grade 1 CNS hemorrhage on the baseline MRI scan.
• History of recent hemoptysis.
• Subjects receiving therapeutic anticoagulation.
• Subjects with a history or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding.
• Systemic autoimmune disease (eg, lupus erythematosus, rheumatoid arthritis, Addison's disease) requiring any treatment within the last 5 years.
• History of organ transplant requiring immunosuppression.
• History of active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
• Dyspnea at rest due to complications of advanced malignancy or other disease requiring continuous oxygen therapy.
• Body weight ≤ 40 kg at screening.
• Inadequate organ function, evidenced by the following laboratory results:
• Absolute neutrophil count (ANC) < 1,000 cells/mm3.
• Hemoglobin < 9 g/dL.
• Platelet count < 100,000 cells/mm3.
• Total bilirubin > 2 × upper limit of normal (ULN; unless the subject has documented Gilbert's syndrome).
• Aspartate aminotransferase (AST [SGOT]) or alanine aminotransferase (ALT [SGPT]) > 2.5 × ULN (> 5 × ULN in subjects with liver metastases).
• Alkaline phosphatase (ALP) levels > 2.5 × ULN (> 5 × ULN in subjects with liver metastases, or > 10 × ULN in subjects with bone metastases).
• Serum creatinine > 2.0 mg/dL or 177 µmol/L.
• Albumin < 3.0 g/dL.
• Note: Each study site should use its institutional Upper Limit of Normal (ULN) to determine eligibility.
• Clinically significant (ie, active) cardiovascular disease or myocardial infarction within 6 months prior to first study medication; unstable angina; congestive heart failure of New York Heart Association grade 2 or higher; or serious cardiac arrhythmia. Subjects with uncontrolled hypertension should be medically managed on a stable regimen to control hypertension prior to study entry.

Where it is running

• Chan Soon-Shiong Institute for Medicine (CSSIFM) — El Segundo, California, United States
• Providence Medical Foundation — Fullerton, California, United States
• Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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