15 withdrawn, 13 completed, 13 terminated, 4 recruiting. 51 Phase 1, 32 Phase 2.
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 | 2026-11-04 | 2026-10-30 |
| 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Alfa Inbakicept (N803), Sotevtamab, Zabadinostat (CXD101) - Pancreatic Cancer Resectable, Pancreatic Cancer | Phase 1 | Withdrawn | ImmunityBio, Inc. | 2026-09-01 | 2026-08-28 | |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 |
| 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in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphomas N803 - B-cell Non Hodgkin Lymphoma | Phase 1 | Withdrawn | University of Utah | 2026-02-01 | 2026-04-01 | |
| Study for Subjects With Relapsed/Refractory Non- Hodgkin Lymphoma N803, CD19t-haNK suspension, Cyclophosphamide - Non Hodgkin's Lymphoma Refractory/Relapsed | Phase 1 | Recruiting | ImmunityBio, Inc. | 20 | 2025-08-22 | 2026-04-01 |
| 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 |
| 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 | 2026-10-16 |
| Single Center Study Of N-803 Stimulation On Expansion, Enrichment, Proliferation Of Natural Killer Cells Collected By Apheresis N-803 - Healthy Subjects | Phase 1 | Completed | ImmunityBio, Inc. | 10 | 2023-10-04 | 2025-10-14 |
| Safety and Efficacy of Neutralizing Antibodies and Vaccination for Induction of HIV Remission VRC07-523LS, PGDM1400LS, N-803 - HIV-1-infection | Phase 1 | Withdrawn | Henry M. Jackson Foundation for the Advancement of Military Medicine | 2023-09-01 | 2024-05-03 | |
| 3BNC117-LS and 10-1074-LS Plus N-803 (bNAb+N-803) 3BNC117-LS, 10-1074-LS, N803 - Human Immunodeficiency Virus | Phase 1 | Completed | Rockefeller University | 28 | 2022-12-07 | 2026-03-31 |
| A Study of Sacituzumab With Chemoimmunotherapy to Treat Advanced Triple-Negative Breast Cancer After Prior Therapies N-803, PD-L1 t-haNK, Sacituzumab Govitecan-Hziy - Advanced Triple Negative Breast Cancer | Phase 1 / Phase 2 | Terminated | ImmunityBio, Inc. | 3 | 2021-09-08 | 2024-06-12 |
| QUILT-3.076: Study of Autologous M-CENK in Subjects With Locally Advanced or Metastatic Solid Tumors M-CENK, Suspension for Infusion, Cryopreserved (M-CENK) (Cohort 2 part B), N-803 (Cohort 2 part B), Apheresis collection of MNCs (part A) - Metastatic Solid Tumor | Phase 1 | Active not recruiting | ImmunityBio, Inc. | 50 | 2021-06-21 | 2025-12-11 |
| 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 N-803 (IL-15 Superagonist), VRC07-523LS, 10-1074 - HIV Infection | Phase 1 | Active not recruiting | National Institute of Allergy and Infectious Diseases (NIAID) | 118 | 2021-05-21 | 2026-08-26 |
| Effect of N-803 on B Cell Follicles in Antiretroviral Treated HIV Disease N-803 - Hiv, HIV Infections | Phase 1 | Completed | University of Minnesota | 10 | 2021-04-01 | 2024-04-02 |
| Study of the Safety of Therapeutic Treatment With an Immunomodulatory Agent (N-803) in Adults With COVID-19 N-803, Saline - COVID-19 | Phase 1 | Terminated | ImmunityBio, Inc. | 1 | 2020-07-22 | 2024-09-05 |
| CIML NK Cell in Head & Neck Cancer Interleukin-15 Superagonist (N-803), CIML NK cell Infusion, Ipilimumab - Squamous Cell Carcinoma of the Head and Neck, Recurrent Head and Neck Squamous Cell Carcinoma | Phase 1 | Completed | Dana-Farber Cancer Institute | 11 | 2020-07-20 | 2026-07-30 |
| Anti-PD-L1/TGF-beta Trap (M7824) Alone and in Combination With TriAd Vaccine and N-803 for Resectable Head and Neck Squamous Cell Carcinoma Not Associated With Human Papillomavirus Infection M7824, N803, TriAd vaccine - Head and Neck Cancer, Head and Neck Neoplasms | Phase 1 / Phase 2 | Completed | National Cancer Institute (NCI) | 21 | 2020-06-09 | 2025-07-16 |
| N-803 Combined With the Broadly Neutralizing Antibodies Plus or Minus haNK Cells for HIV N-803 and bNAbs, haNK™ Cells - Hiv, HIV/AIDS | Phase 1 / Phase 2 | Withdrawn | University of Minnesota | 2020-01-01 | 2020-10-22 |
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Pancreatic Neoplasms (6) · Neoplasms (5) · Carcinoma, Non-Small-Cell Lung (4) · Neoplasm Metastasis (4) · Acquired Immunodeficiency Syndrome (3) · Carcinoma, Transitional Cell (3) · Colorectal Neoplasms (3) · HIV Infections (3) · Leukemia, Lymphocytic, Chronic, B-Cell (3) · Leukemia, Myeloid, Acute (3) · Lymphoma, Non-Hodgkin (3) · Recurrence (3) · Colonic Neoplasms (2) · Leukemia, Myelogenous, Chronic, BCR-ABL Positive (2) · Lymphoma (2)
ImmunityBio, Inc. (26) · Altor BioScience (5) · National Cancer Institute (NCI) (5) · University of Minnesota (3) · Washington University School of Medicine (3) · Brenda Cooper, MD (1) · Dana-Farber Cancer Institute (1) · Henry M. Jackson Foundation for the Advancement of Military Medicine (1) · Masonic Cancer Center, University of Minnesota (1) · Medical University of South Carolina (1) · NantCell, Inc. (1) · National Institute of Allergy and Infectious Diseases (NIAID) (1) · Rockefeller University (1) · University of Utah (1)
United States (40) · India (1) · South Africa (1) · Thailand (1)
Bobby Reddy, MD (2) · Leonard Sender, MD (2) · Timothy Schacker, MD (2) · Amanda Cashen, M.D. (1) · David S Schrump, M.D. (1) · David Wald, MD, PhD (1) · Donn Colby, M.D., M.P.H. (1) · Giordano Fabricio Cittolin Santos, MD, PhD (1) · Hing C Wong, PhD (1) · Hing C. Wong, Ph.D. (1) · Hoyoung M Maeng, M.D. (1) · Hoyoung Maeng, M.D. (1) · James L Gulley, M.D. (1) · Jeffrey S. Miller, MD (1) · John Wrangle, MD (1)
PMID 29463563, PMID 29628312, PMID 30227893, PMID 33602696, PMID 33720067, PMID 33832946, PMID 34797911, PMID 35727629, PMID 38953850, PMID 39948608, PMID 40156838, PMID 40471871, PMID 42498485
5UM1AI126611 (1), F32CA200253 (1), U01AI145921 (1), U01CA154967 (1)