N-803

Phase 3Biologic

IImmunityBio, Inc.

N-803 is one of 250 biologic programs targeting HIV infection. It is currently in Phase 3.

Indications

Total Trials

Active Trials

249

Competitors

Pipeline

Status by Indication[3][1]

Indication

HIV InfectionActive, not recruiting

Long COVID-19Not yet recruiting

Prostate CancerWithdrawn

Bladder CancerActive, not recruiting

GlioblastomaActive, not recruiting

Head and Neck CancerActive, not recruiting

ImmunotherapyNot yet recruiting

Immune Checkpoint InhibitorsActive, not recruiting

Platinum-Resistant Ovarian CancerRecruiting

InterleukinEnrolling by invitation

HIV InfectionPhase 2

Active, not recruiting

Long COVID-19Phase 2

Not yet recruiting

Prostate CancerPhase 2

Withdrawn

Bladder CancerPhase 3

Active, not recruiting

GlioblastomaPhase 2

Active, not recruiting

Head and Neck CancerPhase 2

Active, not recruiting

ImmunotherapyPhase 2

Not yet recruiting

Immune Checkpoint InhibitorsPhase 2

Active, not recruiting

Platinum-Resistant Ovarian CancerPhase 2

Recruiting

InterleukinPhase 2

Enrolling by invitation

Competition

Competitive Landscape

312 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

N-803

IImmunityBio, Inc.

Phase 3

2 2

Provenge

PProstate Oncology Specialists, Inc.

Phase 3

21 3

Fluciclovine

UUniversity of Utah

Phase 3

3 4

Pasritamig

Johnson & Johnson

Phase 3

1 5

SHR3680

JJiangsu HengRui Medicine Co., Ltd.

Phase 3

5 6

Rhpsma-7.3 (18f)

BBlue Earth Diagnostics

Phase 3

4 7

INR101

YYunhe Pharmaceutical (Tianjin) Co., Ltd

Phase 3

3 8

Trexall

Jazz Pharmaceuticals

Preclinical

—9

Jatenzo

GGrupo Espanol de Tumores Neuroendocrinos

Preclinical

2 10

Botox

VVitae Pharmaceuticals Inc., an Allergan affiliate

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Active, not recruiting

HIV Infection

NCT04340596

Q2 2027

Phase 2Recruiting

Platinum-Resistant Ovarian Cancer

NCT06710288

Phase 1Active, not recruiting

Metastatic Solid Tumor

NCT04898543

Phase 2Active, not recruiting

Pancreatic Cancer

NCT04390399

Q4 2027

Phase 2Active, not recruiting

Head and Neck Cancer

NCT04847466

Q4 2028

Phase 2Not yet recruiting

Lymphoma

NCT07477366

Clinical

Trials by Indication[1]

Immunotherapy2 trials

Immunotherapy Before and After Surgery

Not yet recruiting·IImmunityBio, Inc.·Phase 2·NCT06765902·20 enrolled

Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1)

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT03493945·59 enrolled

Prostate Cancer2 trials

Immunotherapy With N 803, ETBX-071, and M-CENK in Combination With Radiation for Participants With High-Risk Prostate Cancer.

Not yet recruiting·IImmunityBio, Inc.·Phase 2·NCT06765954·20 enrolled

N-803 Alone or in Combination With BN-Brachyury Vaccine or Bintrafusp Alfa (M7824) for Participants With Castration Resistant Prostate Cancer

Withdrawn·NNational Cancer Institute (NCI)·Phase 2·NCT05445882

Bladder Cancer2 trials

QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients With BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer

Active, not recruiting·IImmunityBio, Inc.·Phase 2/3·NCT03022825·190 enrolled

Clinical Trial of Ablation Therapy in Participants With Intermediate-Risk Non-Muscle Invasive Papillary Bladder Cancer

Not yet recruiting·IImmunityBio, Inc.·Phase 2·NCT06829823·20 enrolled

HIV infection2 trials

Reducing HIV Persistence in Lymph Nodes by Interleukin-15 (IL-15) Receptor Super-agonist (N-803) in Acute HIV Infection

Active, not recruiting·TThai Red Cross AIDS Research Centre·Phase 2·NCT04505501·14 enrolled

A Phase I Clinical Trial of the Safety, Tolerability, and Efficacy of IL-15 Superagonist (N-803) With and Without Combination Broadly Neutralizing Antibodies to Induce HIV-1 Control During Analytic Treatment Interruption

Active, not recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT04340596·118 enrolled

Natural Killer Cell1 trial

Single Center Study Of N-803 Stimulation On Expansion, Enrichment, Proliferation Of Natural Killer Cells Collected By Apheresis

Completed·IImmunityBio, Inc.·Phase 1·NCT06040918·10 enrolled

29 more indications

HIV1 trial

Effect of N-803 on B Cell Follicles in Antiretroviral Treated HIV Disease

Completed·UUniversity of Minnesota·Phase 1·NCT04808908·10 enrolled

Hepatocellular Carcinoma1 trial

QUILT-3.072: NANT Hepatocellular Carcinoma (HCC) Vaccine

Withdrawn·IImmunityBio, Inc.·Phase 1/2·NCT03563170

Long COVID-191 trial

A Study to Assess Anktiva in Patients With Long Covid-19.

Not yet recruiting·IImmunityBio, Inc.·Phase 2·NCT07108036·20 enrolled

Triple-Negative Breast Cancer1 trial

A Study of Sacituzumab With Chemoimmunotherapy to Treat Advanced Triple-Negative Breast Cancer After Prior Therapies

Terminated·IImmunityBio, Inc.·Phase 1/2·NCT04927884·3 enrolled

Breast Cancer1 trial

QUILT-3.067: NANT Triple Negative Breast Cancer (TNBC) Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With TNBC Who Have Progressed on or After Standard-of-care Therapy.

Terminated·IImmunityBio, Inc.·Phase 1/2·NCT03387085·9 enrolled

Squamous Cell Carcinoma1 trial

QUILT-3.090: NANT Squamous Cell Carcinoma (SCC) Vaccine: Subjects With SCC Who Have Progressed

Terminated·IImmunityBio, Inc.·Phase 1/2·NCT03387111·4 enrolled

Immune1 trial

Ramucirumab, Atezolizumab and N-803 After Progression on Any Immune Checkpoint Blocker in NSCLC

Withdrawn·WWashington University School of Medicine·Phase 2·NCT05007769

Head and Neck Cancer1 trial

Immunotherapy Combination: Irradiated PD-L1 CAR-NK Cells Plus Pembrolizumab Plus N-803 for Subjects With Recurrent/Metastatic Gastric or Head and Neck Cancer

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT04847466·18 enrolled

Immune Checkpoint Inhibitors1 trial

QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors

Active, not recruiting·IImmunityBio, Inc.·Phase 2·NCT03228667·40 enrolled

Prophylaxis1 trial

Relapse Prophylaxis With N-803 for AML and MDS Pts Following Allo HSCT

Completed·MMasonic Cancer Center, University of Minnesota·Phase 2·NCT02989844·20 enrolled

Merkel Cell Carcinoma1 trial

QUILT-3.063: A Study of N-803, haNK and Avelumab in Patients With Merkel Cell Carcinoma That Has Progressed After Checkpoint Therapy

Terminated·IImmunityBio, Inc.·Phase 2·NCT03853317·9 enrolled

Safety and Efficacy1 trial

Safety and Efficacy of Neutralizing Antibodies and Vaccination for Induction of HIV Remission

Withdrawn·HHenry M. Jackson Foundation for the Advancement of Military Medicine·Phase 1·NCT05769569

Refractory1 trial

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

Terminated·AAltor BioScience·Phase 1/2·NCT02384954·43 enrolled

Lymphoma1 trial

Study of CD19 t-haNK and NAI With Rituximab in Participants With Indolent Non-Hodgkin Lymphoma

Not yet recruiting·IImmunityBio, Inc.·Phase 2·NCT07477366·20 enrolled

Interleukin1 trial

Interleukin-15 to Promote Post-ART Control of HIV

Enrolling by invitation·MMichael Peluso, MD·Phase 2·NCT07145164·20 enrolled

Multiple Myeloma1 trial

QUILT-3.005: A Study of N-803 in Patients With Relapsed or Refractory Multiple Myeloma

Terminated·AAltor BioScience·Phase 1·NCT02099539·19 enrolled

COVID-191 trial

Study of the Safety of Therapeutic Treatment With an Immunomodulatory Agent (N-803) in Adults With COVID-19

Terminated·IImmunityBio, Inc.·Phase 1·NCT04385849·1 enrolled

Colorectal Cancer1 trial

Phase II Trial of Combination Immunotherapy in Subjects With Advanced Small Bowel and Colorectal Cancers

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT04491955·32 enrolled

Non-Small Cell Lung Cancer1 trial

Phase I/II Evaluation of a Cancer Lysate Vaccine and Montanide(R) ISA-51 VG With or Without the IL-15 Super-Agonist N-803 as Adjuvant Therapy for PD-L1 Negative Non-Small Cell Lung Cancer

Suspended·NNational Cancer Institute (NCI)·Preclinical·NCT05642195·30 enrolled

Adenocarcinoma1 trial

Phase II Trial of a Multitargeted Recombinant Ad5 PSA/MUC-1/Brachyury-based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT07574541·52 enrolled

Metastatic Solid Tumor1 trial

Phase 1 Open-Label Study of Autologous M-CENK in Subjects With Locally Advanced or Metastatic Solid Tumors

Active, not recruiting·IImmunityBio, Inc.·Phase 1·NCT04898543·50 enrolled

Pancreatic Cancer1 trial

Open-label, Randomized, Comparative Phase 2 Study of Combination Immunotherapy Plus Standard-of-care Chemotherapy Versus Standard-of-care Chemotherapy for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer

Active, not recruiting·IImmunityBio, Inc.·Phase 2·NCT04390399·328 enrolled

NSCLC Stage IV1 trial

Randomized, Two-Cohort, Open-Label, Phase 3 Clinical Trial of N-803 Plus Tislelizumab or Prior Failed Immune Checkpoint Inhibitor and Docetaxel Versus Docetaxel Monotherapy in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Acquired Resistance to Immune Checkpoint Inhibitor Therapy

Recruiting·IImmunityBio, Inc.·Phase 3·NCT06745908·507 enrolled

Metastatic Colorectal Cancer1 trial

Phase I/II Study of the Combination Immunotherapy Regimen: SX-682, TriAdeno Vaccine, Retifanlimab and IL-15 Agonist N-803 (STAR15) for Metastatic Colorectal Cancer (mCRC)

Recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT06149481·60 enrolled

Endometrial Cancer1 trial

Pembrolizumab, Lenvatinib and IL-15 Superagonist N-803 in Combination With HER2 Targeting Autologous Dendritic Cell (AdHER2DC) Vaccine in Participants With Advanced or Metastatic Endometrial Cancer

Recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT06253494·60 enrolled

Recurrent Prostate Cancer1 trial

Phase II Trial of IL-15 Superagonist With or Without Vaccine in Biochemically Recurrent Prostate Cancer After Previous Stereotactic Body Radiation Therapy

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT07686380·65 enrolled

Squamous Cell Carcinoma of the Head and Neck1 trial

A Phase II Sequential Window of Opportunity Trial of Pembrolizumab + N-803 Alone or in Combination With PD-L1 t-haNK Cells for Resectable Head and Neck Squamous Cell Carcinoma

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06161545·40 enrolled

Platinum-resistant Ovarian Cancer1 trial

A Phase 2, Open-label, Single-arm Study Of Autologous Memory Cytokine Enriched Natural Killer (M-CENK) Adoptive Cell Therapy And N-803 (IL-15 Superagonist) In Combination With Gemcitabine In Participants With Recurrent Platinum-Resistant High-Grade Ovarian Cancer

Recruiting·IImmunityBio, Inc.·Phase 2·NCT06710288·20 enrolled

Glioblastoma1 trial

Open-Label, Single-Arm Phase 2 Study of Nogapendekin Alfa Inbakicept, PD-L1 t-haNK, Bevacizumab and Randomized Phase 2B Study of Nogapendekin Alfa Inbakicept, Bevacizumab, and Tumor Treatment Fields With or Without PD-L1 t-haNK in Participants With Recurrent or Progressive Glioblastoma

Active, not recruiting·IImmunityBio, Inc.·Phase 2·NCT06061809·34 enrolled

Sources

References

[1]
ClinicalTrials.gov — 38 trial records for N-803. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — N-803 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for N-803. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — ImmunityBio, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Biologic[2]
Highest Phase: Phase 3[1]
Company: IImmunityBio, Inc.

N-803

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q4 2027

Q4 2028

Trials by Indication[1]

Immunotherapy2 trials

Prostate Cancer2 trials

Bladder Cancer2 trials

HIV infection2 trials

Natural Killer Cell1 trial

HIV1 trial

Hepatocellular Carcinoma1 trial

Long COVID-191 trial

Triple-Negative Breast Cancer1 trial

Breast Cancer1 trial

Squamous Cell Carcinoma1 trial

Immune1 trial

Head and Neck Cancer1 trial

Immune Checkpoint Inhibitors1 trial

Prophylaxis1 trial

Merkel Cell Carcinoma1 trial

Safety and Efficacy1 trial

Refractory1 trial

Lymphoma1 trial

Interleukin1 trial

Multiple Myeloma1 trial

COVID-191 trial

Colorectal Cancer1 trial

Non-Small Cell Lung Cancer1 trial

Adenocarcinoma1 trial

Metastatic Solid Tumor1 trial

Pancreatic Cancer1 trial

NSCLC Stage IV1 trial

Metastatic Colorectal Cancer1 trial

Endometrial Cancer1 trial

Recurrent Prostate Cancer1 trial

Squamous Cell Carcinoma of the Head and Neck1 trial

Platinum-resistant Ovarian Cancer1 trial

Glioblastoma1 trial

References

Drug Info

Quick Facts

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