25 withdrawn, 17 completed, 16 terminated, 13 recruiting. 68 Phase 2, 51 Phase 1, 3 Phase 3, 1 Early Phase 1.
Follow ALT-803: new trials by email Literature Review of ALT-803 trials Research Report on ALT-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 |
| Sipuleucel-T (Sip-T) in Combination With N-803 in Metastatic Androgen Pathway Modulation Resistant (mAPMR) Prostate Cancer Sipuleucel-T, N803 - Prostate Cancer, Metastatic Prostate Cancer | Phase 1 | Not yet recruiting | Washington University School of Medicine | 30 | 2026-11-30 | 2026-08-10 |
| 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 | 2026-10-29 | 2026-10-26 |
| 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 | Not yet recruiting | National Cancer Institute (NCI) | 52 | 2026-10-29 | 2026-10-26 |
| 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 |
| N-803 Maintenance Therapy Post CAR T-cell Therapy in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphomas N803 - B-cell Non Hodgkin Lymphoma | Phase 1 | Withdrawn | University of Utah | 2026-02-01 | 2026-04-01 | |
| 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 | |
| Immunotherapy With N 803, ETBX-071, and M-CENK in Combination With Radiation for Participants With High-Risk Prostate Cancer. N-803 (IL-15 Superagonist), ETBX-071 (PSA-based Oncolytic Virus), M-CENK (Activated NK Cells) - High-risk Prostate Cancer | Phase 2 | Withdrawn | ImmunityBio, Inc. | 2025-12-01 | 2026-05-05 | |
| A Study to Assess Anktiva in Patients With Long Covid-19. N-803 (IL-15 Superagonist) - Long COVID | Phase 2 | Recruiting | ImmunityBio, Inc. | 20 | 2025-11-14 | 2026-05-11 |
| A Phase II Study With a Safety Run-In of the Addition of N-803 to a Chemoimmunotherapy Backbone for the Treatment of Patients With Relapsed or Refractory Neuroblastoma Temozolomide, Irinotecan, hu14.18K322A - Neuroblastoma Recurrent | Phase 2 | Recruiting | St. Jude Children's Research Hospital | 54 | 2025-11-10 | 2026-08-07 |
| 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 In N-803, Tislelizumab, Docetaxel - NSCLC Stage IV | Phase 3 | Recruiting | ImmunityBio, Inc. | 507 | 2025-10-01 | 2026-07-27 |
| 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 |
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Carcinoma, Non-Small-Cell Lung (9) · Pancreatic Neoplasms (8) · Neoplasms (7) · Leukemia, Myeloid, Acute (6) · Prostatic Neoplasms (6) · Colorectal Neoplasms (5) · Squamous Cell Carcinoma of Head and Neck (5) · Acquired Immunodeficiency Syndrome (4) · Carcinoma, Merkel Cell (4) · Carcinoma, Transitional Cell (4) · Myelodysplastic Syndromes (4) · Neoplasm Metastasis (4) · Non-Muscle Invasive Bladder Neoplasms (4) · Recurrence (4) · HIV Infections (3)
ImmunityBio, Inc. (48) · National Cancer Institute (NCI) (11) · Altor BioScience (6) · Washington University School of Medicine (5) · Masonic Cancer Center, University of Minnesota (4) · University of Minnesota (3) · Dana-Farber Cancer Institute (2) · Brenda Cooper, MD (1) · Henry M. Jackson Foundation for the Advancement of Military Medicine (1) · Medical University of South Carolina (1) · Michael Peluso, MD (1) · NantCell, Inc. (1) · National Institute of Allergy and Infectious Diseases (NIAID) (1) · Rockefeller University (1) · SWOG Cancer Research Network (1)
United States (72) · Thailand (2) · Canada (1) · India (1) · South Africa (1) · United Kingdom (1)
Bobby Reddy, MD (4) · Leonard Sender, MD (3) · Amanda Cashen, M.D. (2) · Bruce Brown (2) · Charalampos Floudas, M.D. (2) · Hoyoung Maeng, M.D. (2) · James L Gulley, M.D. (2) · Timothy Schacker, MD (2) · Chad Garner, PhD (1) · Claudio Brunstein, MD, PhD (1) · Daniel Morgensztern, M.D. (1) · David S Schrump, M.D. (1) · David Wald, MD, PhD (1) · Donn Colby, M.D., M.P.H. (1) · Frits van Rhee, MD, PhD (1)
PMID 34797911, PMID 38953850, PMID 29463563, PMID 29628312, PMID 30227893, PMID 33602696, PMID 33720067, PMID 33832946, PMID 35196021, PMID 35727629, PMID 39948608, PMID 40156838, PMID 40471871, PMID 40956664, PMID 41520164, PMID 42498485
5UM1AI126611 (1), F32CA200253 (1), P30CA060553 (1), P50CA171963 (1), U01AI145921 (1), U01CA154967 (1), U10CA180888 (1)