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    DRUG CLASS:

    IL-15 superagonist

    Related drugs:
    1d
    N-803 in Patients With Progressive Synovial Sarcoma and Myxoid/Round Cell Liposarcoma Previously Treated With Adoptive Cellular Therapy (clinicaltrials.gov)
    P1, N=8, Not yet recruiting, Northwestern University
    New P1 trial
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    Anktiva (nogapendekin alfa inbakicept-pmln)
    15d
    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) (clinicaltrials.gov)
    P1/2, N=60, Recruiting, National Cancer Institute (NCI) | Trial completion date: Oct 2028 --> Oct 2030 | Trial primary completion date: Oct 2025 --> Oct 2027
    Trial completion date • Trial primary completion date
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    Zynyz (retifanlimab-dlwr) • SX-682 • Anktiva (nogapendekin alfa inbakicept-pmln)
    15d
    CARMEN-803: N-803 Maintenance Therapy Post CAR T-cell Therapy in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphomas (clinicaltrials.gov)
    P1, N=13, Not yet recruiting, University of Utah | Initiation date: Sep 2025 --> Dec 2025
    Trial initiation date
    |
    Anktiva (nogapendekin alfa inbakicept-pmln)
    1m
    N-803 and PD-L1 t-haNK Combined With Bevacizumab for Recurrent or Progressive Glioblastoma (clinicaltrials.gov)
    P2, N=34, Recruiting, ImmunityBio, Inc. | Active, not recruiting --> Recruiting
    Enrollment open
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    PD-L1 (Programmed death ligand 1)
    |
    Avastin (bevacizumab) • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK
    2ms
    Clinical Trial of Ablation Therapy in Participants With Intermediate-Risk Non-Muscle Invasive Papillary Bladder Cancer (clinicaltrials.gov)
    P2, N=20, Not yet recruiting, ImmunityBio, Inc. | Trial completion date: May 2029 --> Nov 2029 | Initiation date: May 2025 --> Nov 2025 | Trial primary completion date: May 2026 --> Nov 2026
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    gemcitabine • Anktiva (nogapendekin alfa inbakicept-pmln)
    2ms
    QUILT2023: Nogapendekin Alfa Inbakicept for Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=1538, Active, not recruiting, ImmunityBio, Inc. | Trial completion date: Apr 2026 --> Dec 2026 | Trial primary completion date: Oct 2025 --> Oct 2026
    Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    PD-L1 expression • EGFR mutation • BRAF mutation • ALK translocation
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Avastin (bevacizumab) • cisplatin • Tecentriq (atezolizumab) • Yervoy (ipilimumab) • carboplatin • albumin-bound paclitaxel • pemetrexed • Anktiva (nogapendekin alfa inbakicept-pmln)
    2ms
    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 (clinicaltrials.gov)
    P2, N=54, Recruiting, St. Jude Children's Research Hospital | Not yet recruiting --> Recruiting
    Enrollment open
    |
    CSF2 (Colony stimulating factor 2)
    |
    temozolomide • irinotecan • Anktiva (nogapendekin alfa inbakicept-pmln) • Leukine (sargramostim) • humanised dinutuximab (Hu14.18K322A)
    3ms
    N-803 and PD-L1 t-haNK Combined With Bevacizumab for Recurrent or Progressive Glioblastoma (clinicaltrials.gov)
    P2, N=34, Active, not recruiting, ImmunityBio, Inc. | Recruiting --> Active, not recruiting | N=20 --> 34
    Enrollment closed • Enrollment change
    |
    PD-L1 (Programmed death ligand 1)
    |
    Avastin (bevacizumab) • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK
    3ms
    QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors (clinicaltrials.gov)
    P2, N=40, Active, not recruiting, ImmunityBio, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed • Checkpoint inhibition
    |
    BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MSI (Microsatellite instability)
    |
    PD-L1 expression • BRAF V600E • MSI-H/dMMR • PD-L1 overexpression • BRAF V600 • BRAF wild-type
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tecentriq (atezolizumab) • Imfinzi (durvalumab) • docetaxel • Bavencio (avelumab) • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK
    3ms
    Prolonged Progression-Free Survival, Disease-Free Survival and Cystectomy Avoidance with IL-15 Receptor Lymphocyte-Stimulating Agent NAI plus BCG in BCG-Unresponsive Papillary-Only NMIBC. (PubMed, J Urol)
    In QUILT-3.032, the efficacy of IL-15 receptor agonist, nogapendekin alfa inbakicept (NAI) in combination with BCG for BCG-unresponsive high-grade papillary-only non-muscle invasive bladder cancer (NMIBC) was assessed...Most TRAEs were grade 1-2 (61%) with 3% grade 3, and no grade 4-5. The 12- and 36-month DFS, PFS, DSS, and cystectomy avoidance rates demonstrate the effectiveness and safety of NAI plus BCG in the management of BCG-unresponsive papillary disease.
    Journal
    |
    IL15 (Interleukin 15)
    |
    Anktiva (nogapendekin alfa inbakicept-pmln)
    3ms
    ResQ201A: Clinical Trial Of N-803 Plus TISLELIZUMAB And DOCETAXEL Versus DOCETAXEL Monotherapy In Participants With Advanced Or Metastatic Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=460, Recruiting, ImmunityBio, Inc. | Initiation date: May 2025 --> Sep 2025
    Trial initiation date • Checkpoint inhibition
    |
    docetaxel • Tevimbra (tislelizumab-jsgr) • Anktiva (nogapendekin alfa inbakicept-pmln)
    4ms
    A Study of FL115 Monotherapy in Unresectable or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=30, Recruiting, Suzhou Forlong Biotechnology Co.,Ltd,
    New P1 trial