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Cytokine

N-803 for Human Immunodeficiency Virus Infection

Phase 1
Waitlist Available
Led By Timothy Schacker, MD
Research Sponsored by University of Minnesota
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 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial tests N-803, a drug that reactivates hidden HIV and boosts immune cells to clear it, in HIV-infected adults on effective ART. The goal is to reduce hidden HIV by making it visible and attacking it with immune cells. N-803, formerly known as ALT-803, is an IL-15 superagonist initially developed as an anti-cancer biologic and has been extended into HIV research for its potent immunostimulatory properties.

Eligible Conditions
  • Human Immunodeficiency Virus (HIV) Infection
  • HIV/AIDS
  • Inflammation
  • HIV (Human Immunodeficiency Virus)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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
Safety (Adverse Event Rate)
Secondary study objectives
Frequency of CD8+ T Cells in Follicles

Side effects data

From 2024 Phase 2 trial • 32 Patients • NCT04491955
100%
Injection site reaction
92%
Flu like symptoms
42%
Anemia
42%
Abdominal pain
42%
Aspartate aminotransferase increased
42%
Fatigue
42%
Rash acneiform
33%
Alanine aminotransferase increased
33%
Fever
33%
Pruritus
25%
Disease progression
25%
Alkaline phosphatase increased
25%
Dyspnea
25%
Urinary tract infection
17%
Back pain
17%
Dysuria
17%
Chills
17%
Constipation
17%
Proteinuria
17%
Epistaxis
17%
Hyperglycemia
17%
Nausea
17%
Pain in extremity
17%
Vomiting
8%
Lung infection
8%
Hematuria
8%
General disorders and administration site conditions - Other, specify
8%
Lethargy
8%
Cardiac troponin I increased
8%
Sepsis
8%
Adrenal insufficiency
8%
Edema face
8%
Blood bilirubin increased
8%
Cough
8%
Dry skin
8%
Gastric ulcer
8%
General disorders and administration site conditions - Other, Mucosal bleeding
8%
Hot flashes
8%
Hypokalemia
8%
Hypophosphatemia
8%
Infusion related reaction
8%
Mucositis oral
8%
Myalgia
8%
Oral hemorrhage
8%
Papulopustular rash
8%
Paresthesia
8%
Skin hyperpigmentation
8%
Thrush
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1, Arm 1 Triple Therapy Without NHS-IL12 (M9241)
Cohort 2, Arm 2a, Dose Level (DL) DL2, Quad Therapy Dose Escalation
Cohort 2, Arm 2a Dose Level (DL) 1, Quad Therapy Dose Escalation
Cohort 2, Arm 2b Dose Level (DL)2, Quad Therapy Fixed Dose

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: N-803Experimental Treatment1 Intervention
All participants will receive the intervention, N-803 treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
N-803
2021
Completed Phase 2
~80

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,316 Previous Clinical Trials
5,547,738 Total Patients Enrolled
University of MinnesotaLead Sponsor
1,423 Previous Clinical Trials
1,619,775 Total Patients Enrolled
Timothy Schacker, MDPrincipal InvestigatorUniversity of Minnesota
7 Previous Clinical Trials
99 Total Patients Enrolled
~2 spots leftby Nov 2025
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