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GlioblastomaPhase 2NCT06061809

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

A Phase 2 study testing Bevacizumab, PD-L1 t-haNK and N-803 in people with Glioblastoma, run by ImmunityBio, Inc. at 4 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma
What is being tested?
Bevacizumab, PD-L1 t-haNK and N-803
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
4 sitesUnited States
Study dates
7 Aug 2024to 31 Dec 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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.
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  • 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.
  • Current, serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.
  • Known hypersensitivity to any component of the study medication(s).
  • Participation in an investigational drug study or receiving any investigational treatment within 28 days prior to study treatment. No wash out is necessary for subjects previously receiving Tumor treating field (TTF); TTF will be allowed to continue at the discretion of the Investigator. FDA-authorized drugs for the prevention and treatment of COVID-19 are permitted.
  • Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
  • Concurrent participation in any interventional clinical trial.
  • Pregnant and nursing women.
  • Phase 2B Inclusion Criteria
  • Age ≥ 22 years.
  • Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
  • Histologically-confirmed GBM in accordance with the 2021 WHO CNS5 (grade 4 Glioma, IDH-wildtype) that has progressed after initial therapy or therapies (prior surgical resection if feasible, plus radiotherapy with concurrent and/or adjuvant temozolomide), limited to first-line progression. A second surgical resection is allowed but not required. Gliosarcoma, small cell GBM or other GBM variants, and molecular GBM are allowed.
  • Progressive or recurrent disease will be confirmed (ie, contrast enhanced magnetic resonance imaging [MRI] performed within 4 weeks prior to study treatment per RANO v02 criteria or diagnostic biopsy), or progression that does not meet RANO v02 criteria if the disease progression is otherwise obvious in the opinion of the Investigator and is discussed with the Medical Monitor. Participants must be a minimum of 3 months from the completion of radiotherapy to distinguish true progression from pseudoprogression.
  • Previous first-line treatment with at least radiotherapy and temozolomide.
  • Have received and recovered from standard treatments. At least 4 weeks since any cytotoxic chemotherapy (eg, temozolomide/nitrosoureas), 28 days since any investigational agent, and 6 to 12 weeks since radiation before starting study drug(s).
  • Willingness to use TTFields device. Both experimental arms require wearing the TTFields device ≥ 18 hours a day. Participants must be willing to shave their head twice a week and use the TTFields device as instructed. They should have no scalp condition or implanted device that contraindicates TTFields use (eg, no non-MRI-safe metal in the skull, ventricular peritoneal shunt is generally okay, but no active scalp infections or wounds).
  • Life expectancy ≥ 12 weeks.
  • ECOG performance status of 0 to 2.
  • Have recovered from prior treatment-related toxicities to grade 2 or less.
  • Ability to attend required study visits and return for adequate follow-up, as required by this protocol.
  • Agreement to practice highly effective contraception for female participants of childbearing potential and nonsterile males. Female participants of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause. Female participants of childbearing potential must have a negative pregnancy test and adhere to using a highly effective method of contraception (eg, tubal ligation, approved hormonal contraceptive, or an intrauterine device [IUD]) prior to screening and agree to continue its use during the study or be surgically sterilized (eg, hysterectomy) while on study and for 7 months post last dose of study drug. Male participants must agree to use barrier methods of birth control while on study and for 7 months post last dose of study drug.
  • Craniotomy must be adequately healed (at least 28 days between study treatment initiation and surgery).
  • Received any further therapy beyond initial first-line therapy other than surgical resection.
  • Prior therapy with bevacizumab for GBM.
  • Serious uncontrolled concomitant disease that would contraindicate the use of the investigational drugs used in this study or that would put the participant at high risk for treatment-related complications.
  • History of surgery in the past 28 days or with surgical wound not healed.
  • History of serious hemorrhage as defined by NCI CTCAE v5.0 grading.
  • Evidence of > grade 1 CNS hemorrhage on the baseline MRI scan.
  • History of recent hemoptysis.
  • Participants receiving therapeutic anticoagulation or antiplatelet therapy.
  • Participants 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).
  • Prior use of anti-PD1 or PD-L1 immunotherapy or cellular therapy targeting PD-1/PD-L1 (or any NK cell therapy) for GBM.
  • Prior treatment with TTFields.
  • Uncontrolled seizures or neurological instability.
  • Should not require high-dose corticosteroids (eg, dexamethasone dose of ≤ 4 mg/day, or lowest dose to manage symptoms).
  • Other active malignancy requiring treatment.
  • Body weight ≤ 40 kg at screening.
  • Inadequate organ function, evidenced by the following laboratory results:
  • ANC < 1,000 cells/mm3.
  • Hemoglobin < 8 g/dL.
  • Platelet count < 100,000 cells/mm3.
  • Total bilirubin > 2 × ULN. For participants with documented Gilbert's syndrome, total bilirubin must be < 3 × ULN.
  • AST (SGOT) or ALT (SGPT) > 2.5 × ULN (> 5 × ULN in participants with liver metastases).
  • ALP levels > 2.5 × ULN (> 5 × ULN in participants with liver metastases, or > 10 × ULN in participants with bone metastases).
  • Serum creatinine > 2.0 mg/dL or 177 µmol/L. Note: Each study site should use its institutional 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. Participants with uncontrolled hypertension should be medically managed on a stable regimen to control hypertension prior to study entry.
  • Current, serious, clinically significant cardiac arrhythmias, defined as the existence of an absolute arrhythmia or ventricular arrhythmias classified as Lown III, IV or V.
  • Known hypersensitivity to any component of the study medication(s).
  • Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol, including the use of the TTFields device as required or any psychiatric/social situation that would limit adherence to protocol.
  • Participation in an investigational drug study or receiving any investigational treatment within 28 days prior to study treatment or concurrent participation in any interventional clinical trial.
  • Pregnant and nursing women.
  • Active implanted medical device, a skull defect (such as, missing bone with no replacement) or bullet fragments. Examples of active electronic devices include deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers, defibrillators, and programmable shunts.
  • Known sensitivity to conductive hydrogels like the gel used on transcutaneous electrical nerve stimulation (TENS) electrodes.
  • A tumor located in the lower parts of the brain close to the spinal cord.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Chan Soon-Shiong Institute for Medicine (CSSIFM)

    El Segundo, California, 90245

  • Providence Medical Foundation

    Fullerton, California, 92835

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37203

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

Other trials in United States

About this study

Official title: Open-Label, Single-Arm Phase 2 Study of Nogapendekin Alfa Inbakicept, PD-L1 t-haNK, Bevacizumab and Randomized Phase 2B Study of Nogapendekin Alfa Inbakicept, Bevacizumab, and Tumor Treatment Fields With or Without PD-L1 t-haNK in Participants With Recurrent or Progressive Glioblastoma

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)

Read more

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
Glioblastoma
Being tested
Bevacizumab, PD-L1 t-haNK, N-803, Tumor Treating Fields (TTFields, 200 kHz)
Keywords
Progressive Glioblastoma, Recurrent Glioblastoma, N-803, ALT-803, PD-L1 t-haNK, Immunotherapy, Bevacizumab, Glioblastoma
Medical subject headings
Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BevacizumabDrug

    Also called Avastin

    Participants will receive 10mg/kg of Bevacizumab intravenously (IV) on Day 1 and Day 15 of each repeated cycle of treatment.

  • PD-L1 t-haNKDrug

    Participants will receive PD-L1 t-haNK (~2 × 109 cells/infusion) intravenously (IV) on Day 1 and Day 15 of each repeated cycle of treatment.

  • N-803Drug

    Also called ALT-803, Anktiva

    Participants will receive 1mg subcutaneously (SC) on Day 1 and Day 15 of each repeated cycle of treatment.

  • Tumor Treating Fields (TTFields, 200 kHz)Device

    TTFields (OPTUNE Gio®), for the treatment of newly diagnosed and/or recurrent GBM, is a portable battery or power supply operated device which produces alternating electrical fields, called tumor treatment fields ("TTFields") within the human body/brain. TTFields are applied to the patient by electrically-insulated surface transducer arrays. TTFields disrupt the rapid cell division exhibited by cancer cells. TTFields is comprised of two main components: (1) an Electric Field Generator and (2) INE Insulated Transducer Arrays (the transducer arrays). Patients carry the device in an over-the-shoulder bag or backpack and receive continuous treatment without changing their daily routine.

Study groups in NCT06061809
Study groupRoleWhat they receive
Single ArmExperimentalPhase 2 Participants will receive N-803 1 mg subcutaneously (SC), PD-L1 t-haNK (~2 × 10^9 cells/infusion) intravenously (IV), and Bevacizumab (10 mg/kg IV) combination therapy during 28-day cycles on days 1 and 15 of each cycle. Maximum treatment period is 76 weeks, 19 cycles.
Receives: Drug: Bevacizumab; Drug: PD-L1 t-haNK; Drug: N-803
Experiment Treatment Arm AExperimentalPhase 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): N-803, 1 mg SC Bevacizumab, 10 mg/kg IV Continuous application (≥ 18 hours/day) to the brain: TTFields, 200 kHz
Receives: Drug: Bevacizumab; Drug: N-803; Device: Tumor Treating Fields (TTFields, 200 kHz)
Experiment Treatment Arm BExperimentalParticipants 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). Every 2 weeks (Days 1, 15, 29, and 43 of an 8-week cycle): PD-L1 t-haNK, 2 × 109 cells per infusion IV NAI, 1 mg SC Bevacizumab, 10 mg/kg IV Plus - Continuous application (≥ 18 hours/day) to the brain: TTFields, 200 kHz
Receives: Drug: Bevacizumab; Drug: PD-L1 t-haNK; Drug: N-803; Device: Tumor Treating Fields (TTFields, 200 kHz)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

    TEAEs and SAEs graded using the NCI CTCAE v5.0

    Measured: From beginning of Cycle 1 (each cycle is 28 days) to 30 days after end of treatment study visit.

  2. Incidence of clinically significant changes in comprehensive metabolic panel (CMP)

    Standard blood chemistry panel made up of 14 separate chemistry measurements so can detect a range of abnormalities in blood sugar, nutrient balance, and liver and kidney health. Each clinical site will use their local laboratory upper limit of normal (ULN) range. The treating investigator will assess each result composing the CMP and determine if each result is within expected normal range or outside of the expected normal range.

    Measured: From baseline, pre-intervention, Cycle 1 (each cycle is 28 days) and each subsequent treatment Cycle on Days 1 and Day 15 and at the end of treatment study visit.

  3. Incidence of clinically significant changes in Hematology blood panel.

    Blood test checking the levels for White Blood Cell, Red Blood Cell, Platelets, Hemoglobin, Hematocrit, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils per unit volume. Each clinical site will use their local laboratory upper limit of normal (ULN) range. The treating investigator will assess each component of the Hematology panel and determine if each result is within expected normal range or outside of the expected normal range.

    Measured: From baseline, pre-intervention, Cycle 1 (each cycle is 28 days) and each subsequent treatment Cycle on Days 1 and Day 15 and at the end of treatment study visit.

  4. Incidence of clinically significant changes in Urinalysis.

    Checking the appearance, concentration and content of urine for any abnormalities. Each clinical site will use their local laboratory upper normal limit (UNL) range. The treating investigator will assess each component of the urinalysis and determine if each result is within expected normal range or outside of the expected normal range.

    Measured: From baseline, pre-intervention, Cycle 1 (each cycle is 28 days) and each subsequent treatment Cycle on Days 1 and Day 15 and at the end of treatment study visit.

  5. 12-lead Electrocardiogram (ECG)

    Perform 12-lead ECG as safety monitoring measurement. The parameters to be assessed for each one are the following: QT Interval, QTc Interval, QTcB Interval, QTcF Interval, PR Interval, QRS Duration and RR Interval with the unit in msec.

    Measured: From baseline, pre-intervention, Cycle 1 (each cycle is 28 days) and each subsequent Cycle Day1 through to the end of treatment study visit.

  6. Incidence of clinically significant changes in Temperature

    Temperature measured in either Fahrenheit or Celsius and for any abnormalities. Each site will assess to determine if temperature is within expected normal range or outside of the expected normal range.

    Measured: From baseline, pre-intervention, Cycle 1 (each cycle is 28 days) and Cycle 2 on days 1, 2 and 15, followed by each subsequent treatment Cycle on Days 1 and 15 and on the end of treatment study visit.

  7. Incidence of clinically significant changes in Heart Rate

    Heart rate measured in beats/minute. Each site will assess to determine if heart rate is within expected normal range or outside of the expected normal range.

    Measured: From baseline, pre-intervention, Cycle 1 (each cycle is 28 days) and Cycle 2 on days 1, 2 and 15, followed by each subsequent treatment Cycle on Days 1 and 15 and on the end of treatment study visit.

  8. Incidence of clinically significant changes in Respiratory Rate

    Respiratory rate measured in breaths/minute. Each site will assess to determine if respiratory rate is within expected normal range or outside of the expected normal range.

    Measured: From baseline, pre-intervention, Cycle 1 (each cycle is 28 days) and Cycle 2 on days 1, 2 and 15, followed by each subsequent treatment Cycle on Days 1 and 15 and on the end of treatment study visit.

  9. Incidence of clinically significant changes in Blood Pressure

    Blood pressure measured in Systolic and Diastolic mmHg. Each site will assess to determine if blood pressure is within expected normal range or outside of the expected normal range.

    Measured: From baseline, pre-intervention, Cycle 1 (each cycle is 28 days) and Cycle 2 on days 1, 2 and 15, followed by each subsequent treatment Cycle on Days 1 and 15 and on the end of treatment study visit.

  10. Incidence of clinically significant changes in Oxygen Saturation

    A pulse oximeter measures oxygen saturation as a percentage. Determines the ratio of the current levels of oxygenated hemoglobin to deoxygenated hemoglobin. Each site will assess to determine if oxygen saturation is within expected normal range or outside of the expected normal range.

    Measured: From baseline, pre-intervention, Cycle 1 (each cycle is 28 days) and Cycle 2 on days 1, 2 and 15, followed by each subsequent treatment Cycle on Days 1 and 15 and on the end of treatment study visit.

  11. Neurological assessment to grade Immune effector cell-associated neurotoxicity syndrome (ICANS)

    Using a 10-point immune effector cell encephalopathy [ICE] score for the grading of ICANS. A score of 10 represents no impairment, 7-9 score is grade 1 ICANS, 3-6 score is grade 2 ICANS, 0-2 score is grade 3 ICANS and finally grade 4 ICANs is where cannot perform assessment of tasks.

    Measured: On Cycle 1 (each cycle is 28 days) Day1, Day2, Day 15 and Day16, followed by each subsequent treatment Cycle on Days 1 and 15. Collection stops at the end of treatment study visit.

  12. Safety assessed by Cytokine Levels

    The safety cytokine levels are TNF-α and IL-6

    Measured: From Cycle 1 (each cycle is 28 days) Day1, Day2, Day 15 and Day16, followed by each subsequent treatment Cycle on Day 1. Collection stops at the end of treatment study visit.

Secondary outcomes (4)

  1. Concentration of N-803 Pharmacokinetic (PK)

    Profile of each participant PK profile of N-803 from their serum sample

    Measured: On Cycle 1 (each cycle is 28 days) and Cycle 3 on treatment days 1, 2, 3, 4, 5 and 8.

  2. Concentration of PD-L1 t-haNK Pharmacokinetic (PK)

    Profile of each participant PK profile of PD-L1 t-haNK from their serum sample

    Measured: On Cycle 1 (each cycle is 28 days) and Cycle 3 on treatment days 1, 2, 3, 4, 5 and 8.

  3. Detection of Immunogenicity of N-803

    Detection of N-803 in each participant ADA serum blood samples

    Measured: On Cycle 1 (each cycle is 28 days) Cycle 2 on treatment days 1 and 15, followed by Cycle 7 Day 1 and at the End of Treatment study visit.

  4. Detection of Immunogenicity of PD-L1 t-haNK

    Detection of PD-L1 t-haNK in each participant ADA serum blood samples

    Measured: On Cycle 1 (each cycle is 28 days) Cycle 2 on treatment days 1 and 15, followed by Cycle 7 Day 1 and at the End of Treatment study visit.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2023
  2. Study start7 Aug 2024
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06061809
Sponsor's protocol ID
QUILT-3.078
Status last verified
Oct 2025
First submitted
12 Sep 2023
Last updated
1 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab, PD-L1 t-haNK and N-803 in people with Glioblastoma, run by ImmunityBio, Inc. at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 80 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) (time frame: From beginning of Cycle 1 (each cycle is 28 days) to 30 days after end of treatment study visit.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06061809.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.

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