N-803 and PD-L1 t-haNK Combined With Bevacizumab for Recurrent or Progressive Glioblastoma - Trial NCT06061809

Timeline & Enrollment

Primary Outcome

Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs),Incidence of clinically significant changes in comprehensive metabolic panel (CMP),Incidence of clinically significant changes in Hematology blood panel.,Incidence of clinically significant changes in Urinalysis.,12-lead Electrocardiogram (ECG),Incidence of clinically significant changes in Temperature,Incidence of clinically significant changes in Heart Rate,Incidence of clinically significant changes in Respiratory Rate,Incidence of clinically significant changes in Blood Pressure,Incidence of clinically significant changes in Oxygen Saturation,Neurological assessment to grade Immune effector cell-associated neurotoxicity syndrome (ICANS),Safety assessed by Cytokine Levels

Summary

This is a phase 2 open-label study to evaluate the safety and efficacy of N-803 and PD-L1
 t-haNK when combined with Bevacizumab in subjects with recurrent or progressive GBM.
 
 Participants will receive N-803 subcutaneously (SC), PD-L1 t-haNK intravenously (IV), and
 Bevacizumab IV combination therapy.
 
 Treatment for all enrolled participants will consist of repeated cycles of 28 days for a
 maximum treatment period of 76 weeks (19 cycles). Treatment will be administered on days 1
 and day 15 of each cycle. Treatment will be discontinued if the participant reports
 unacceptable toxicity (not corrected with dose reduction), withdraws consent, if the
 Investigator feels it is no longer in the participant's best interest to continue treatment,
 or the participant has confirmed progressive disease by iRANO, unless the participant is
 potentially deriving benefit per Investigator's assessment. Participants will be followed for
 collection of survival status every 12 weeks (± 2 weeks) for the first 2 years, then yearly
 thereafter.

ICD-10 Classifications