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Monoclonal Antibodies

N-803 + PD-L1 t-haNK + Bevacizumab for Glioblastoma

Phase 2
Recruiting
Research Sponsored by ImmunityBio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years.
Histologically-confirmed glioblastoma in accordance with the 2021 WHO Classification of Tumors of the CNS (WHO CNS5) that has progressed after initial therapy or therapies. The digital image to be provided for confirmation of histology by the Sponsor. Gliosarcoma, small cell GBM or other GBM variants, and molecular GBM are allowed.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing the safety and effectiveness of a combination treatment for subjects with recurrent or progressive GBM using N-803, PD-L1 t-haNK, and Bevacizumab.

Who is the study for?
This trial is for adults over 18 with glioblastoma that's worsened after initial treatments. They should have a life expectancy of more than 12 weeks, be able to consent, and have had prior therapy including radiotherapy and temozolomide. Participants need a performance status score indicating they can carry out daily activities and must agree to use effective contraception.
What is being tested?
The study tests the combination of N-803 (given under the skin), PD-L1 t-haNK (given into the vein), and Bevacizumab (also IV) in patients with recurrent or progressive glioblastoma. Treatments are given in cycles every two weeks up to 76 weeks unless side effects become too severe or disease progresses.
What are the potential side effects?
Potential side effects include reactions at injection sites, fatigue, allergic responses, increased risk of infection due to immune system changes, bleeding issues from Bevacizumab, high blood pressure, and possible organ inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My brain tumor is confirmed as glioblastoma and has worsened after treatment.
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I have recovered from previous cancer treatment side effects.
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I am mostly able to care for myself and carry out daily activities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
12-lead Electrocardiogram (ECG)
Incidence of clinically significant changes in Blood Pressure
Incidence of clinically significant changes in Heart Rate
+9 more
Secondary study objectives
Concentration of N-803 Pharmacokinetic (PK)
Concentration of PD-L1 t-haNK Pharmacokinetic (PK)
Detection of Immunogenicity of N-803
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pilot Combination TherapyExperimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5540
N-803
2021
Completed Phase 2
~80

Find a Location

Who is running the clinical trial?

ImmunityBio, Inc.Lead Sponsor
66 Previous Clinical Trials
4,739 Total Patients Enrolled
1 Trials studying Glioblastoma
28 Patients Enrolled for Glioblastoma
~13 spots leftby Dec 2029
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