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NCT06061809 · ClinicalTrials.gov registry record · Phase 2
N-803 and PD-L1 t-haNK Combined With Bevacizumab for Recurrent or Progressive Glioblastoma
A Phase 2 study of Glioblastoma, sponsored by ImmunityBio.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
- 4
- Study locations
NCT06061809 is a Phase 2 study of Glioblastoma that is actively recruiting participants, run by ImmunityBio. The registered enrollment target is 34 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (69% lower). The trial reports 4 study locations across 2 states.
The verdict
NCT06061809, a Phase 2 study of Glioblastoma, is actively recruiting participants, sponsored by ImmunityBio.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
- 4
- Study locations
Study 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. 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 wh
Conditions Studied
Interventions
- DRUG Bevacizumab
- DRUG N-803
- DRUG PD-L1 t-haNK
- DEVICE Tumor Treating Fields (TTFields, 200 kHz)
Study Locations (4)
California
- Chan Soon-Shiong Institute for Medicine (CSSIFM) - El Segundo
- Providence Medical Foundation - Fullerton
- Hoag Memorial Hospital Presbyterian - Newport Beach
Tennessee
- Vanderbilt-Ingram Cancer Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2024-08-07 |
| Est. Completion | 2030-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06061809
The ClinicalTrials.gov registry entry for NCT06061809 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (69% lower). The listed sponsor is ImmunityBio, which has 46 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Glioblastoma appearing as the primary indexed condition, and to 4 interventions - of which Bevacizumab is the first listed.
NCT06061809 reports 4 study locations spanning 2 distinct geographic areas - top geographies include California, Tennessee.
Frequently Asked Questions
What is clinical trial NCT06061809 about?
NCT06061809 is a clinical study titled "N-803 and PD-L1 t-haNK Combined With Bevacizumab for 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 evalua...
What is the current status of trial NCT06061809?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2024-08-07. Estimated completion is 2030-12-31.
What conditions does trial NCT06061809 study?
This clinical trial studies the following conditions: Glioblastoma.
What interventions are being tested in trial NCT06061809?
The interventions under investigation include: Bevacizumab (DRUG), N-803 (DRUG), PD-L1 t-haNK (DRUG), Tumor Treating Fields (TTFields, 200 kHz) (DEVICE).
Who is sponsoring clinical trial NCT06061809?
This trial is sponsored by ImmunityBio, which has 46 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06061809 being conducted?
This trial has 4 study locations across California, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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