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

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status changed: Recruiting → Active, Not Recruiting Site details revised at 4 of 4 sitesv14 Show 1 more changeShow less
    • Site details revised at 4 of 4 sites
  2. Study sites: 3 to 4v13
  3. Trial status: Active, Not Recruiting to Recruiting Site details revised at 3 of 3 sitesv12 Show 1 more changeShow less
    • Site details revised at 3 of 3 sites
  4. Re-verified, no change to tracked fieldsv11
  5. Enrollment target: 20 to 34 Trial status: Recruiting to Active, Not Recruiting · Study sites: 2 to 3 · Interventions: Bevacizumab (Drug), N-803 (Drug), PD-L1 t-haNK (Drug) to Bevacizumab (Drug), N-803 (Drug), PD-L1 t-haNK (Drug), Tumor Treating Fields (TTFields, 200 kHz) (Device) · 2 morev10 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 2 to 3
    • Interventions: Bevacizumab (Drug), N-803 (Drug), PD-L1 t-haNK (Drug) to Bevacizumab (Drug), N-803 (Drug), PD-L1 t-haNK (Drug), Tumor Treating Fields (TTFields, 200 kHz) (Device)
    • Eligibility criteria expanded, about 1,007 words
    • Study arms: 1 to 3

    See this version in full on ClinicalTrials.gov ↗

Show 8 earlier versionsHide 8 earlier versions
  1. Re-verified, no change to tracked fieldsv9
  2. Study sites: 1 to 2v8
  3. Start date changed from estimate of Jul 17, 2024 to Aug 7, 2024 Site contact updatedv7 Show 1 more changeShow less
    • Site contact updated
  4. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v6 Show 1 more changeShow less
    • Study sites: 0 to 1
  5. Start date: Jun 3, 2024 to Jul 17, 2024v5
  6. Start date: Apr 19, 2024 to Jun 3, 2024v4
  7. Start date: Feb 29, 2024 to Apr 19, 2024v3
  8. Primary completion date: Dec 31, 2028 to Dec 31, 2029 Start date: Nov 16, 2023 to Feb 29, 2024 · Completion date: Dec 31, 2029 to Dec 31, 2030v2 Show 2 more changesShow less
    • Start date: Nov 16, 2023 to Feb 29, 2024
    • Completion date: Dec 31, 2029 to Dec 31, 2030
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT06061809
Lead Sponsor ImmunityBio, Inc.
Conditions Glioblastoma
Enrollment 34 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov