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Immunostimulant

QUILT-3.002: N-803 in Patients With Relapse/Refractory iNHL in Conjunction With Rituximab

Phase 1 & 2
Waitlist Available
Research Sponsored by Altor BioScience
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This is a Phase I/II, open-label, multi-center, competitive enrollment and dose escalation study of N-803 in patients with relapse/refractory indolent B cell non-Hodgkin lymphoma in conjunction with rituximab.

Eligible Conditions
  • Indolent B Cell Non-Hodgkin Lymphomas

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
MTD or MED of N-803: IV 1, 3, 6 μg/kg, SQ 6, 10, 15, 20 μg/kg
Number of Participants With Treatment Emergent Adverse Events
Overall Response Rate
Secondary study objectives
Blood Cell Counts
Duration of Response
Immunogenicity
+7 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

9Treatment groups
Experimental Treatment
Group I: Phase 2 Cohort 2: Anti-CD20 mAb-refractory N-803 - SQ 20 ug/kgExperimental Treatment2 Interventions
Group II: Phase 2 Cohort 1: Anti-CD20 mAb-sensitive N-803 - SQ 20 ug/kgExperimental Treatment2 Interventions
Group III: Phase 1 Cohort 7: N-803 - SQ 20 ug/kgExperimental Treatment2 Interventions
Group IV: Phase 1 Cohort 6: N-803 - SQ 15 ug/kgExperimental Treatment2 Interventions
Group V: Phase 1 Cohort 5: N-803 - SQ 10 ug/kgExperimental Treatment2 Interventions
Group VI: Phase 1 Cohort 4: N-803 - SQ 6 ug/kgExperimental Treatment2 Interventions
Group VII: Phase 1 Cohort 3: N-803 - IV 6 ug/kgExperimental Treatment2 Interventions
Group VIII: Phase 1 Cohort 2: N-803 - IV 3 ug/kgExperimental Treatment2 Interventions
Group IX: Phase 1 Cohort 1: N-803 - IV 1 ug/kgExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
N-803
2021
Completed Phase 2
~130
Rituximab
FDA approved

Find a Location

Who is running the clinical trial?

Altor BioScienceLead Sponsor
17 Previous Clinical Trials
478 Total Patients Enrolled
~4 spots leftby Jan 2026