^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG CLASS:

    IL-15R agonist

    Related drugs:
    8d
    A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBC (clinicaltrials.gov)
    P3, N=236, Not yet recruiting, Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Initiation date: Mar 2026 --> Jun 2026
    Trial initiation date
    |
    gemcitabine • epirubicin • mitomycin • Pinorubin (pirarubicin) • SHR-1501
    19d
    A Phase I Study of JL19001 Injection Alone or in Combination With Standard Therapy in Patients With Advanced Solid Tumors or Relapsed/Refractory B-cell Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P1, N=14, Not yet recruiting, Jecho Biopharmaceuticals Co., Ltd.
    New P1 trial
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • MET (MET proto-oncogene, receptor tyrosine kinase) • NRAS (Neuroblastoma RAS viral oncogene homolog) • CXCL8 (Chemokine (C-X-C motif) ligand 8) • IL4 (Interleukin 4)
    |
    KRAS mutation • EGFR mutation • KRAS G12C • BRAF mutation • NRAS mutation • BRAF V600 • KIT mutation • ALK fusion • KRAS G12 • NTRK fusion
    2ms
    A Phase I/II Study of JL19001 Injection Alone or in Combination with BCG in Subjects with High Risk Non-Muscle Invasive Bladder Cancer. (ChiCTR2600120806)
    P1/2, N=111, West China Hospital of Sichuan University; Jecho Biopharmaceuticals Co., Ltd.
    New P1/2 trial
    |
    CXCL8 (Chemokine (C-X-C motif) ligand 8) • IL4 (Interleukin 4)
    3ms
    JL19001-NMIBC: A Phase I/II Study of JL19001 Injection Alone or in Combination With BCG in Subjects With High Risk Non-Muscle Invasive Bladder Cancer. (clinicaltrials.gov)
    P1, N=18, Not yet recruiting, Jecho Biopharmaceuticals Co., Ltd.
    New P1 trial
    4ms
    A Study of Intravesical SHR-1501 Combination With BCG Versus Investigator-selected Chemotherapy in Subjects With BCG-unresponsive NMIBC (clinicaltrials.gov)
    P3, N=236, Not yet recruiting, Suzhou Suncadia Biopharmaceuticals Co., Ltd.
    New P3 trial
    |
    gemcitabine • epirubicin • mitomycin • Pinorubin (pirarubicin) • SHR-1501
    4ms
    A Study of ASKG915 in Patients With Selected Advanced Solid Tumors. (clinicaltrials.gov)
    P1/2, N=594, Recruiting, AskGene Pharma, Inc. | Phase classification: P1 --> P1/2 | N=104 --> 594 | Trial completion date: Dec 2025 --> Jun 2028 | Trial primary completion date: Mar 2024 --> Dec 2026
    Phase classification • Enrollment change • Trial completion date • Trial primary completion date
    |
    Avastin (bevacizumab) • paclitaxel • docetaxel • Fruzaqla (fruquintinib) • ASKG915
    5ms
    Phase I/II Clinical Study of SHR-1501 Combined With Adbelizumab in Patients With Malignant Tumors (clinicaltrials.gov)
    P1/2, N=203, Recruiting, Shanghai Hengrui Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    AiRuiLi (adebrelimab) • SHR-1501
    5ms
    NKTR-255, a polymer-conjugated IL-15, synergizes with CAR-T cell therapy to activate endogenous anti-tumor immunity and improve tumor control. (PubMed, bioRxiv)
    Consequently, NKTR-255 and CAR-T combination therapy induced complete elimination of ROR1 + tumor and significantly improved survival, with enhanced tumor control dependent on activity of both CAR-Ts and endogenous T cells. Altogether, our data suggest that combining NKTR-255 with CAR-T therapy is a promising strategy to enhance both CAR-T and endogenous anti-tumor immunity to promote coordinated control of aggressive tumors.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-1 (Programmed cell death 1) • ROR1 (Receptor Tyrosine Kinase Like Orphan Receptor 1) • ITGAM (Integrin, alpha M) • IL15 (Interleukin 15)
    |
    avipendekin pegol (NKTR-255)
    6ms
    REStoring lymphoCytes Using NKTR-255* After chemoradiothErapy in Solid Tumors (RESCUE) (clinicaltrials.gov)
    P2, N=39, Recruiting, M.D. Anderson Cancer Center | Trial primary completion date: Dec 2025 --> Dec 2027
    Trial primary completion date
    |
    Imfinzi (durvalumab) • avipendekin pegol (NKTR-255)
    8ms
    CXCL10-induced chemotaxis of ex vivo-expanded natural killer cells combined with NKTR-255 enhances anti-tumor efficacy in osteosarcoma. (PubMed, Mol Ther Oncol)
    Single-cell RNA sequencing and mass cytometry revealed upregulated apoptosis and transforming growth factor-β (TGF-β) signaling as the potential mechanisms of response/resistance to NK cell therapy in vivo. Our findings highlight potential application of chemokine-enhanced NK tumor infiltration in combination with an IL-15 agonist as a novel approach to effective treatment of OSA.
    Preclinical • Journal
    |
    CXCL10 (Chemokine (C-X-C motif) ligand 10) • CXCL9 (Chemokine (C-X-C motif) ligand 9) • TGFB1 (Transforming Growth Factor Beta 1) • CXCR3 (C-X-C Motif Chemokine Receptor 3) • IL15 (Interleukin 15)
    |
    avipendekin pegol (NKTR-255)
    9ms
    NCI-2022-02316: NKTR-255 in Combination With CAR-T Cell Therapy for the Treatment of Relapsed or Refractory Large B-cell Lymphoma (clinicaltrials.gov)
    P1, N=28, Active, not recruiting, Fred Hutchinson Cancer Center | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    CD19 (CD19 Molecule)
    |
    cyclophosphamide • Breyanzi (lisocabtagene maraleucel) • fludarabine IV • avipendekin pegol (NKTR-255)
    10ms
    IL-15 Superagonist SHR-1501 Enhances Immune Responses in Lung Cancer by Modulating Tumor Microenvironment. (PubMed, Clin Respir J)
    SHR-1501 demonstrated potent antitumor activity, especially when combined with PD-1 mAb. Its mechanism likely involves promoting CD8+ T cell and NK cell infiltration and enhancing M1 macrophage activity. These findings provide evidence for further clinical trials exploring SHR-1501 in nonsmall cell lung cancer (NSCLC) therapy.
    Journal
    |
    KRAS (KRAS proto-oncogene GTPase) • CD8 (cluster of differentiation 8)
    |
    KRAS G12D • KRAS G12
    |
    SHR-1501