OncoMatch/Clinical Trials/NCT06061809
N-803 and PD-L1 t-haNK Combined With Bevacizumab for Recurrent or Progressive Glioblastoma
Is NCT06061809 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Bevacizumab and PD-L1 t-haNK for glioblastoma.
Treatment: Bevacizumab · PD-L1 t-haNK · N-803 · Tumor Treating Fields (TTFields, 200 kHz) — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: IDH1 wild-type
Disease stage
Grade: 4 (who cns5)
Prior therapy
Must have received: radiation therapy — first-line
Previous first line treatment with at least radiotherapy and temozolomide
Must have received: cytotoxic chemotherapy (temozolomide) — first-line
Previous first line treatment with at least radiotherapy and temozolomide
Cannot have received: bevacizumab or other anti-angiogenic treatment (bevacizumab)
Prior anticancer treatment of glioblastoma with bevacizumab or other anti-angiogenic treatment
Cannot have received: anti-PD-1 therapy
Prior use of anti-PD1 or PD-L1 immunotherapy or cellular therapy targeting PD-1/PD-L1 (or any NK cell therapy) for GBM
Cannot have received: cellular therapy targeting PD-1/PD-L1 or NK cell therapy
Prior use of anti-PD1 or PD-L1 immunotherapy or cellular therapy targeting PD-1/PD-L1 (or any NK cell therapy) for GBM
Cannot have received: TTFields
Prior treatment with TTFields
Cannot have received: investigational agent
Participation in an investigational drug study or receiving any investigational treatment within 28 days prior to study treatment
Lab requirements
Blood counts
ANC ≥ 1,000 cells/mm3; Hemoglobin ≥ 9 g/dL (or ≥ 8 g/dL in phase 2B); Platelet count ≥ 100,000 cells/mm3; Albumin ≥ 3.0 g/dL
Kidney function
Serum creatinine ≤ 2.0 mg/dL or 177 µmol/L
Liver function
Total bilirubin ≤ 2 × ULN (≤ 3 × ULN with Gilbert's syndrome); AST/ALT ≤ 2.5 × ULN (≤ 5 × ULN with liver metastases); ALP ≤ 2.5 × ULN (≤ 5 × ULN with liver metastases, ≤ 10 × ULN with bone metastases)
Cardiac function
No clinically significant (active) cardiovascular disease or myocardial infarction within 6 months; no unstable angina; no congestive heart failure NYHA grade 2 or higher; no serious cardiac arrhythmia
Inadequate organ function, evidenced by the following laboratory results: ANC < 1,000 cells/mm3; Hemoglobin < 9 g/dL (or < 8 g/dL in phase 2B); Platelet count < 100,000 cells/mm3; Total bilirubin > 2 × ULN (or > 3 × ULN with Gilbert's syndrome); AST/ALT > 2.5 × ULN (> 5 × ULN with liver metastases); ALP > 2.5 × ULN (> 5 × ULN with liver metastases, > 10 × ULN with bone metastases); Serum creatinine > 2.0 mg/dL or 177 µmol/L; Albumin < 3.0 g/dL. No 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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Chan Soon-Shiong Institute for Medicine (CSSIFM) · El Segundo, California
- Providence Medical Foundation · Fullerton, California
- Hoag Memorial Hospital Presbyterian · Newport Beach, California
- Vanderbilt-Ingram Cancer Center · Nashville, Tennessee
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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