11 recruiting, 8 terminated, 7 withdrawn, 6 completed. 34 Phase 2, 17 Phase 1, 3 Phase 3, 1 Early Phase 1.
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 |
|---|---|---|---|---|---|---|
| N-803 in Combination With Pembrolizumab and Enfortumab Vedotin for Treatment of Urothelial Cancer Nogapendekin Alfa Inbakicept (NAI), enfortumab vedotin (EV), Pembrolizumab - Metastatic Urothelial Carcinoma, Urothelial Carcinoma | Phase 1 | Not yet recruiting | ImmunityBio, Inc. | 18 | 2026-12-01 | 2026-09-24 |
| 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 | 2026-11-08 | 2026-11-03 |
| 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 | 2026-11-08 | 2026-11-03 |
| 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 |
| Open-Label, Phase 1 Clinical Trial of Neoadjuvant Nogapendekin Alfa Inbakicept, Sotevtamab, and Zabadinostat in Combination With Gemcitabine and Nab-Paclitaxel for Participants With Borderline Resectable or Locally Advanced Pancreatic Cancer Nogapendekin Alfa Inbakicept (N803), Sotevtamab, Zabadinostat (CXD101) - Pancreatic Cancer Resectable, Pancreatic Cancer | Phase 1 | Withdrawn | ImmunityBio, Inc. | 2026-09-01 | 2026-08-28 | |
| 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 | |
| N-803 in Patients With Progressive Synovial Sarcoma and Myxoid/Round Cell Liposarcoma Previously Treated With Adoptive Cellular Therapy Biospecimen Collection, Computed Tomography, Leukapheresis - Myxoid Liposarcoma, Round Cell Liposarcoma | Early Phase 1 | Recruiting | Seth Pollack | 8 | 2026-04-13 | 2026-08-27 |
| 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 |
| 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 N-803, Tislelizumab, Docetaxel - NSCLC Stage IV | Phase 3 | Recruiting | ImmunityBio, Inc. | 507 | 2025-10-01 | 2026-11-02 |
| 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 | 2026-10-16 |
Showing 20 of 45. Sign in to see all of them.
Carcinoma, Non-Small-Cell Lung (5) · Neoplasms (4) · Prostatic Neoplasms (4) · Lymphopenia (3) · Sepsis (3) · Acquired Immunodeficiency Syndrome (2) · Carcinoma (2) · Colorectal Neoplasms (2) · Critical Illness (2) · Non-Muscle Invasive Bladder Neoplasms (2) · Pancreatic Neoplasms (2) · Recurrence (2) · Squamous Cell Carcinoma of Head and Neck (2) · Urinary Bladder Neoplasms (2) · Adenocarcinoma (1)
ImmunityBio, Inc. (22) · National Cancer Institute (NCI) (10) · Altor BioScience (3) · Washington University School of Medicine (2) · Dana-Farber Cancer Institute (1) · Henry M. Jackson Foundation for the Advancement of Military Medicine (1) · Masonic Cancer Center, University of Minnesota (1) · Michael Peluso, MD (1) · SWOG Cancer Research Network (1) · Seth Pollack (1) · Thai Red Cross AIDS Research Centre (1) · University of Minnesota (1)
United States (35) · Thailand (2) · Canada (1) · United Kingdom (1)
Bobby Reddy, MD (2) · Charalampos Floudas, M.D. (2) · James L Gulley, M.D. (2) · Leonard Sender, MD (2) · Bruce Brown (1) · Chad Garner, PhD (1) · Claudio Brunstein, MD, PhD (1) · Daniel Morgensztern, M.D. (1) · David S Schrump, M.D. (1) · Donn Colby, M.D., M.P.H. (1) · Giordano Fabricio Cittolin Santos, MD, PhD (1) · Hing C Wong, PhD (1) · Hoyoung M Maeng, M.D. (1) · Hoyoung Maeng, M.D. (1) · John M Wrangle (1)
PMID 30227893, PMID 33602696, PMID 33832946, PMID 38953850, PMID 40471871, PMID 40956664, PMID 41520164, PMID 42498485
5UM1AI126611 (1), P30CA060553 (1), U10CA180888 (1)