Actively Recruiting
N-803 and PD-L1 t-haNK Combined With Bevacizumab for Recurrent or Progressive Glioblastoma
Led by ImmunityBio, Inc. · Updated on 2026-02-12
34
Participants Needed
4
Research Sites
333 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
N-803 and PD-L1 t-haNK Combined With Bevacizumab for Recurrent or Progressive Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older (phase 2) or 22 years or older (phase 2B).
- Able to understand and provide signed informed consent.
- Histologically confirmed glioblastoma per 2021 WHO CNS5 classification with progression after initial therapy.
- Evidence of progressive or recurrent disease confirmed by recent MRI or biopsy.
- Prior first-line treatment with radiotherapy and temozolomide.
- At least 28 days off prior treatment and 90 days from radiation completion (phase 2) or minimum 3 months from radiotherapy completion (phase 2B).
- Recovery from prior treatment-related toxicities to Grade 2 or less.
- Life expectancy greater than 12 weeks.
- Karnofsky Performance Status 70 or higher (phase 2) or ECOG performance status 0 to 2 (phase 2B).
- Ability to attend required study visits and follow-up.
- Agreement to use effective contraception during and after study treatment.
- Craniotomy must be healed for at least 28 days before starting treatment.
- Willingness to use the TTFields device as instructed (phase 2B only).
You will not qualify if you...
- Serious uncontrolled diseases or conditions contraindicating study drugs or increasing treatment risk.
- Prior treatment with bevacizumab or other anti-angiogenic agents for glioblastoma.
- Current chronic daily systemic corticosteroid use above specified doses.
- Recent surgery within 28 days or unhealed surgical wounds.
- History of serious hemorrhage or evidence of CNS hemorrhage greater than Grade 1 on MRI.
- Recent hemoptysis.
- Use of therapeutic anticoagulation or antiplatelet therapy.
- History or evidence of bleeding disorders or significant coagulopathy.
- Systemic autoimmune disease requiring treatment within last 5 years.
- History of organ transplant requiring immunosuppression.
- Active inflammatory bowel disease.
- Dyspnea at rest requiring continuous oxygen therapy.
- Body weight 40 kg or less at screening.
- Inadequate organ function based on specified laboratory thresholds.
- Clinically significant cardiovascular disease or serious arrhythmias.
- Known hypersensitivity to any study medication component.
- Participation in other investigational drug studies within 28 days or concurrent interventional trials.
- Pregnant or nursing women.
- Presence of active implanted medical devices, skull defects, or sensitivity to conductive hydrogels (phase 2B only).
- Prior use of anti-PD1/PD-L1 or NK cell therapies or prior TTFields treatment (phase 2B only).
- Uncontrolled seizures or neurological instability (phase 2B only).
- Requirement for high-dose corticosteroids (phase 2B only).
- Other active malignancy needing treatment (phase 2B only).
- Tumor located in lower brain near spinal cord (phase 2B only).
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Chan Soon-Shiong Institute for Medicine (CSSIFM)
El Segundo, California, United States, 90245
Not Yet Recruiting
2
Providence Medical Foundation
Fullerton, California, United States, 92835
Actively Recruiting
3
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
Actively Recruiting
4
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
R
Raymond Atiata
CONTACT
M
Mark Nelson
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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