9 recruiting, 5 active not recruiting, 5 terminated, 5 withdrawn. 34 Phase 2, 10 Phase 1, 2 Phase 3.
Follow N-803: new trials by email Literature Review of N-803 trials Research Report on N-803
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| 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 TriAdeno vaccine, N-803 - Adenocarcinoma, Prostate Cancer | Phase 2 | Recruiting | National Cancer Institute (NCI) | 52 | 2026-11-15 | 2026-11-10 |
| Evaluation of a Cancer Lysate Vaccine and Montanide (Registered Trademark) 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 Montanide (Registered Trademark) ISA-51 VG Adjuvant, H1299 Cell Lysates, N-803 - Non-Small Cell Lung Cancer, Non-Small Cell Lung Carcinoma | Phase 1 / Phase 2 | Suspended | National Cancer Institute (NCI) | 30 | 2026-11-15 | 2026-11-10 |
| NAI Plus Standard of Care Compared With Placebo Plus Standard of Care in Critically Ill Adults With Sepsis Nogapendekin alfa inbakicept (NAI), Placebo - Sepsis | Phase 2 | Not yet recruiting | ImmunityBio, Inc. | 50 | 2026-10-15 | 2026-09-25 |
| IL-15 Superagonist With or Without Vaccine in Biochemically Recurrent Prostate Cancer After Previous Stereotactic Body Radiation Therapy N-803, ETBX-71 Vaccine, 18F-DCFPyL - Recurrent Prostate Cancer, Prostate Cancer | Phase 2 | Recruiting | National Cancer Institute (NCI) | 65 | 2026-10-01 | 2026-10-06 |
| First-Line Ipilimumab Plus Nivolumab and Nogapendekin Alfa Inbakicept (N-803) in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer Ipilimumab, Nivolumab, Nogapendekin alfa inbakicept - Non-small Cell Lung Cancer Stage IV, Non-small Cell Lung Cancer Recurrent | Phase 1 / Phase 2 | Recruiting | Washington University School of Medicine | 26 | 2026-07-07 | 2026-07-10 |
| NAI for Sepsis With Persistent Lymphopenia Nogapendekin alfa inbakicept (NAI), Standard of Care (SOC) - Sepsis, Septic Shock | Phase 2 | Not yet recruiting | ImmunityBio, Inc. | 50 | 2026-07-06 | 2026-05-11 |
| Nogapendekin Alfa-Inbakicept and iNKT Cells for Critically Ill Adults With Severe Community-Acquired Pneumonia (With or Without Sepsis/ARDS) Nogapendekin Alfa-Inbakicept (NAI), Allogeneic invariant Natural Killer T (iNKT) Cells (AgenT-797) - Acute Respiratory Distress Syndrome, Severe Community-Acquired Pneum | Phase 2 | Withdrawn | ImmunityBio, Inc. | 2026-04-15 | 2026-05-08 | |
| Study of CD19 t-haNK and NAI With Rituximab in Participants With Indolent Non-Hodgkin Lymphoma CD19 t-haNK- IV Administration, N-803, rituximab - Relapsed B-Cell Non-Hodgkin Lymphoma | Phase 2 | Not yet recruiting | ImmunityBio, Inc. | 20 | 2026-04-01 | 2026-03-17 |
| Immunotherapy Before and After Surgery N-803, ETBX-071, M-CENK - High-risk Prostate Cancer | Phase 2 | Withdrawn | ImmunityBio, Inc. | 2025-12-15 | 2026-05-05 | |
| Clinical Trial of Ablation Therapy in Participants With Intermediate-Risk Non-Muscle Invasive Papillary Bladder Cancer N-803 and BCG, N-803 and Gemcitabine - Non-muscle Invasive Bladder Cancer (NMIBC) | Phase 2 | Not yet recruiting | ImmunityBio, Inc. | 20 | 2025-11-01 | 2025-10-16 |
| Pembrolizumab + N-803 Alone or in Combination With PD-L1 t-haNK Cells for Resectable Head and Neck Squamous Cell Carcinoma PD-L1 t-haNK cells, pembrolizumab, N-803 - Stage II Squamous Cell Carcinoma of the Head and Neck, Stage III Squamous Cell Carcinoma of the Head and Neck | Phase 2 | Recruiting | National Cancer Institute (NCI) | 40 | 2025-09-24 | 2026-09-18 |
| A Study to Examine Anktiva for the Treatment of COVID-19. Anktiva - Long COVID, Long COVID Syndrome | Phase 2 | Recruiting | ImmunityBio, Inc. | 40 | 2025-09-04 | 2026-09-24 |
| Interleukin-15 to Promote Post-ART Control of HIV N-803, Saline placebo - HIV | Phase 2 | Enrolling by invitation | Michael Peluso, MD | 20 | 2025-08-19 | 2026-01-22 |
| A Phase 2, Open-label, Single-arm Study Of Autologous 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 Gemcitabine, N-803, M-CENK - Platinum-resistant Ovarian Cancer | Phase 2 | Recruiting | ImmunityBio, Inc. | 20 | 2024-11-06 | 2026-07-01 |
| N-803 and PD-L1 t-haNK Combined With Bevacizumab for Recurrent or Progressive Glioblastoma Bevacizumab, PD-L1 t-haNK, N-803 - Glioblastoma | Phase 2 | Active not recruiting | ImmunityBio, Inc. | 34 | 2024-08-07 | 2026-07-01 |
| 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 AdHER2DC vaccine, Pembrolizumab, N-803 - Endometrial Cancer, Cancer of Endometrium | Phase 1 / Phase 2 | Recruiting | National Cancer Institute (NCI) | 60 | 2024-05-14 | 2026-11-05 |
| N-803 Alone or in Combination With BN-Brachyury Vaccine or Bintrafusp Alfa (M7824) for Participants With Castration Resistant Prostate Cancer Bintrafusp alfa, N-803, BN-Brachyury - Castration Resistant Prostate Cancer | Phase 2 | Withdrawn | National Cancer Institute (NCI) | 2024-04-01 | 2024-04-02 | |
| 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) Retifanlimab, Therapeutic CEA, Brachyury and MUC1 TriAdeno Vaccine Platform, N-803 - Metastatic Colorectal Cancer | Phase 1 / Phase 2 | Recruiting | National Cancer Institute (NCI) | 60 | 2024-03-26 | 2026-11-09 |
| PD-L1 t-haNK, NAI IL-15sa and Cetuximab for Recurrent, Metastatic HNSCC PD-L1 t-haNK, Cetuximab, NAI - Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma | Phase 2 | Recruiting | Dana-Farber Cancer Institute | 25 | 2024-02-16 | 2026-10-19 |
| Testing the Use of Combination Immunotherapy Treatment (N-803 [ALT-803] Plus Pembrolizumab) Against the Usual Treatment for Advanced Non-small Cell Lung Cancer (A Lung-MAP Treatment Trial) Cobalamin, Dexamethasone, Docetaxel - Advanced Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma | Phase 2 / Phase 3 | Active not recruiting | SWOG Cancer Research Network | 82 | 2022-03-15 | 2026-05-18 |
Showing 20 of 34. Sign in to see all of them.
Carcinoma, Non-Small-Cell Lung (4) · Prostatic Neoplasms (4) · Neoplasms (3) · Sepsis (3) · Carcinoma (2) · Colorectal Neoplasms (2) · Critical Illness (2) · Lymphopenia (2) · Non-Muscle Invasive Bladder Neoplasms (2) · Squamous Cell Carcinoma of Head and Neck (2) · Acquired Immunodeficiency Syndrome (1) · Adenocarcinoma (1) · Carcinoma, Merkel Cell (1) · Carcinoma, Squamous Cell (1) · Community-Acquired Pneumonia (1)
ImmunityBio, Inc. (16) · National Cancer Institute (NCI) (10) · Washington University School of Medicine (2) · Altor BioScience (1) · Dana-Farber Cancer Institute (1) · Masonic Cancer Center, University of Minnesota (1) · Michael Peluso, MD (1) · SWOG Cancer Research Network (1) · Thai Red Cross AIDS Research Centre (1)
United States (26) · Thailand (1)
Bobby Reddy, MD (2) · Charalampos Floudas, M.D. (2) · James L Gulley, M.D. (2) · Bruce Brown (1) · Claudio Brunstein, MD, PhD (1) · Daniel Morgensztern, M.D. (1) · David S Schrump, M.D. (1) · Giordano Fabricio Cittolin Santos, MD, PhD (1) · Hoyoung M Maeng, M.D. (1) · Hoyoung Maeng, M.D. (1) · John M Wrangle (1) · Karim Chamie, MD (1) · Lennie Sender, MD (1) · Leonard Sender, MD (1) · Melissa L Abel, M.D. (1)
PMID 30227893, PMID 33602696, PMID 33832946, PMID 38953850, PMID 40956664, PMID 41520164, PMID 42498485
U10CA180888 (1)