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    DRUG:

    PD-L1.t-haNK

    i
    Other names: PD-L1.t-haNK, PD-L1.t-haNK cell therapy, PD-L1 t-haNK
    Associations

    News

    Trials
    Company:
    ImmunityBio
    Drug class:
    PD-L1 inhibitor
    Related drugs:
    Associations

    News

    Trials
    1m
    QUILT-88: Combination Immunotherapy Plus Standard-of-Care Chemotherapy Versus Standard-of-Care Chemotherapy for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer (clinicaltrials.gov)
    P2, N=328, Active, not recruiting, ImmunityBio, Inc. | Trial completion date: Oct 2024 --> Oct 2025 | Trial primary completion date: Oct 2024 --> Oct 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • cyclophosphamide • leucovorin calcium • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK • aldoxorubicin (INNO-206)
    2ms
    Recurrent pancreatic cancer treated with N-803 and PD-L1 t-haNK followed by an EGFR-targeted nanocell drug conjugate. (PubMed, Oncologist)
    The epidermal growth factor receptor-targeted antibody-nanocell conjugate E-EDV-D682 provides tumor-targeted chemotherapy in the form of its anthracycline metabolite PNU159682 (nemorubicin) cargo and is currently being studied in combination with immunomodulatory EDVs delivering the adjuvant α-galactosyl ceramide (GC)...Under the initial single-patient Investigational New Drug (spIND) protocol, the patient received N-803, PD-L1 t-haNK cells, and the albumin doxorubicin conjugate aldoxorubicin for ~27 months...Due to progression, a second spIND protocol was designed whereby the patient received E-EDV-D682 plus EDV-GC for more than 24 months, which resulted in stable disease and the patient's continued survival at the time this report was written. The patient's extended survival despite the dire prognosis associated with recurrent mPC points to the merits of this temporal combination regimen in overcoming immuno-chemo resistance with enhanced immune activity required for tumor response and extended survival.
    Journal
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule) • IL15 (Interleukin 15)
    |
    Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK • aldoxorubicin (INNO-206)
    3ms
    QUILT 3.064: QUILT-3.064: PD-L1 t-haNK In Subjects With Locally Advanced Or Metastatic Solid Cancers (clinicaltrials.gov)
    P1, N=16, Active, not recruiting, ImmunityBio, Inc. | Trial primary completion date: Jun 2024 --> Oct 2024
    Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1.t-haNK
    3ms
    QUILT-88: Combination Immunotherapy Plus Standard-of-Care Chemotherapy Versus Standard-of-Care Chemotherapy for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer (clinicaltrials.gov)
    P2, N=328, Active, not recruiting, ImmunityBio, Inc. | Trial primary completion date: Jun 2024 --> Oct 2024
    Trial primary completion date • Metastases
    |
    gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • cyclophosphamide • leucovorin calcium • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK • aldoxorubicin (INNO-206)
    3ms
    QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors (clinicaltrials.gov)
    P2, N=147, Active, not recruiting, ImmunityBio, Inc. | Phase classification: P2b --> P2 | Trial completion date: Dec 2024 --> Dec 2030 | Trial primary completion date: May 2024 --> Aug 2029
    Phase classification • Trial completion date • Trial primary completion date • Checkpoint inhibition
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MSI (Microsatellite instability)
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tecentriq (atezolizumab) • Imfinzi (durvalumab) • Bavencio (avelumab) • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK
    4ms
    N-803 and PD-L1 t-haNK Combined With Bevacizumab for Recurrent or Progressive Glioblastoma (clinicaltrials.gov)
    P2, N=20, Recruiting, ImmunityBio, Inc. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha)
    |
    Avastin (bevacizumab) • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK
    5ms
    QUILT-3.058: A Study of Sacituzumab With Chemoimmunotherapy to Treat Advanced Triple-Negative Breast Cancer After Prior Therapies (clinicaltrials.gov)
    P1/2, N=3, Terminated, ImmunityBio, Inc. | Phase classification: P1b/2 --> P1/2
    Phase classification • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    cyclophosphamide • Trodelvy (sacituzumab govitecan-hziy) • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK
    8ms
    QUILT-505: PD-L1 t-haNK, N-803 IL-15sa and Cetuximab for Recurrent, Metastatic HNSCC (clinicaltrials.gov)
    P2, N=25, Recruiting, Glenn J. Hanna | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    Erbitux (cetuximab) • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK
    9ms
    QUILT 3.064: QUILT-3.064: PD-L1 t-haNK In Subjects With Locally Advanced Or Metastatic Solid Cancers (clinicaltrials.gov)
    P1, N=16, Active, not recruiting, ImmunityBio, Inc. | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Sep 2023 --> Jun 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    PD-L1.t-haNK
    9ms
    QUILT-505: PD-L1 t-haNK, N-803 IL-15sa and Cetuximab for Recurrent, Metastatic HNSCC (clinicaltrials.gov)
    P2, N=25, Not yet recruiting, Glenn J. Hanna
    New P2 trial • Metastases
    |
    Erbitux (cetuximab) • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK
    10ms
    QUILT-88: Combination Immunotherapy Plus Standard-of-Care Chemotherapy Versus Standard-of-Care Chemotherapy for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer (clinicaltrials.gov)
    P2, N=328, Active, not recruiting, ImmunityBio, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • cyclophosphamide • leucovorin calcium • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK • aldoxorubicin (INNO-206)
    11ms
    N-803 and PD-L1 t-haNK Combined With Bevacizumab for Recurrent or Progressive Glioblastoma (clinicaltrials.gov)
    P2, N=20, Not yet recruiting, ImmunityBio, Inc. | Trial completion date: Dec 2029 --> Dec 2030 | Initiation date: Nov 2023 --> Feb 2024 | Trial primary completion date: Dec 2028 --> Dec 2029
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha)
    |
    Avastin (bevacizumab) • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK
    12ms
    Pembrolizumab + N-803 Alone or in Combination With PD-L1 t-haNK Cells for Resectable Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, National Cancer Institute (NCI)
    New P2 trial
    |
    Keytruda (pembrolizumab) • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK
    1year
    N-803 and PD-L1 t-haNK Combined With Bevacizumab for Recurrent or Progressive Glioblastoma (clinicaltrials.gov)
    P2, N=20, Not yet recruiting, ImmunityBio, Inc.
    New P2 trial
    |
    PD-L1 (Programmed death ligand 1) • IL6 (Interleukin 6)
    |
    Avastin (bevacizumab) • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK
    1year
    QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors (clinicaltrials.gov)
    P2b, N=147, Active, not recruiting, ImmunityBio, Inc. | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: May 2023 --> May 2024
    Trial completion date • Trial primary completion date • Checkpoint inhibition
    |
    PD-L1 (Programmed death ligand 1) • 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) • Bavencio (avelumab) • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK
    over1year
    QUILT-3.058: A Study of Sacituzumab With Chemoimmunotherapy to Treat Advanced Triple-Negative Breast Cancer After Prior Therapies (clinicaltrials.gov)
    P1b/2, N=3, Terminated, ImmunityBio, Inc. | N=79 --> 3 | Trial completion date: Oct 2028 --> Jan 2023 | Active, not recruiting --> Terminated | Trial primary completion date: Oct 2024 --> Jan 2023; Study not meeting recruitment goals
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 overexpression • HER-2 amplification • PGR expression
    |
    cyclophosphamide • Trodelvy (sacituzumab govitecan-hziy) • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK
    over2years
    QUILT-3.058: A Study of Sacituzumab With Chemoimmunotherapy to Treat Advanced Triple-Negative Breast Cancer After Prior Therapies (clinicaltrials.gov)
    P1b/2, N=79, Active, not recruiting, ImmunityBio, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 overexpression • HER-2 amplification • PGR expression
    |
    cyclophosphamide • Trodelvy (sacituzumab govitecan-hziy) • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK
    almost3years
    Immunotherapy Combination: Irradiated PD-L1 CAR-NK Cells Plus Pembrolizumab Plus N-803 for Subjects With Recurrent/Metastatic Gastric or Head and Neck Cancer (clinicaltrials.gov)
    P2, N=55, Recruiting, National Cancer Institute (NCI) | Suspended --> Recruiting
    Enrollment open
    |
    PD-L1 (Programmed death ligand 1)
    |
    HER-2 positive
    |
    Keytruda (pembrolizumab) • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK
    almost3years
    Immunotherapy Combination: Irradiated PD-L1 CAR-NK Cells Plus Pembrolizumab Plus N-803 for Subjects With Recurrent/Metastatic Gastric or Head and Neck Cancer (clinicaltrials.gov)
    P2, N=55, Suspended, National Cancer Institute (NCI) | Recruiting --> Suspended
    Trial suspension
    |
    PD-L1 (Programmed death ligand 1)
    |
    HER-2 positive
    |
    Keytruda (pembrolizumab) • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK
    3years
    Immunotherapy Combination: Irradiated PD-L1 CAR-NK Cells Plus Pembrolizumab Plus N-803 for Subjects With Recurrent/Metastatic Gastric or Head and Neck Cancer (clinicaltrials.gov)
    P2, N=55, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting
    Enrollment open
    |
    PD-L1 (Programmed death ligand 1)
    |
    HER-2 positive
    |
    Keytruda (pembrolizumab) • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK
    3years
    QUILT-3.058: A Study of Sacituzumab With Chemoimmunotherapy to Treat Advanced Triple-Negative Breast Cancer After Prior Therapies (clinicaltrials.gov)
    P1b/2, N=79, Recruiting, ImmunityBio, Inc. | Not yet recruiting --> Recruiting
    Clinical • Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HER-2 overexpression • HER-2 amplification • PGR expression
    |
    cyclophosphamide • Trodelvy (sacituzumab govitecan-hziy) • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK
    3years
    QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors (clinicaltrials.gov)
    P2b, N=145, Active, not recruiting, ImmunityBio, Inc. | Trial completion date: Aug 2021 --> Dec 2023 | Trial primary completion date: Jun 2021 --> May 2023
    Clinical • Trial completion date • Trial primary completion date • Checkpoint inhibition
    |
    PD-L1 (Programmed death ligand 1) • 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
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tecentriq (atezolizumab) • Imfinzi (durvalumab) • Bavencio (avelumab) • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK
    over3years
    QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors (clinicaltrials.gov)
    P2b, N=145, Active, not recruiting, ImmunityBio, Inc. | Recruiting --> Active, not recruiting | N=636 --> 145
    Clinical • Enrollment closed • Enrollment change • Checkpoint inhibition
    |
    PD-L1 (Programmed death ligand 1) • 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
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tecentriq (atezolizumab) • Imfinzi (durvalumab) • Bavencio (avelumab) • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK
    over3years
    Immunotherapy Combination: Irradiated PD-L1 CAR-NK Cells Plus Pembrolizumab Plus N-803 for Subjects With Recurrent/Metastatic Gastric or Head and Neck Cancer (clinicaltrials.gov)
    P2, N=55, Not yet recruiting, National Cancer Institute (NCI)
    Clinical • New P2 trial
    |
    PD-L1 (Programmed death ligand 1)
    |
    HER-2 positive
    |
    Keytruda (pembrolizumab) • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK
    4years
    QUILT 3.064: PD-L1 t-haNK In Subjects With Locally Advanced Or Metastatic Solid Cancers (clinicaltrials.gov)
    P1, N=16, Active, not recruiting, NantKwest, Inc. | Recruiting --> Active, not recruiting
    Clinical • Enrollment closed
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    PD-L1.t-haNK
    over4years
    QUILT-3.055: A Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment With Immune Checkpoint Inhibitors (clinicaltrials.gov)
    P2b, N=611, Recruiting, Altor BioScience | Trial completion date: Aug 2020 --> Aug 2021 | Trial primary completion date: Jun 2020 --> Jun 2021
    Clinical • Trial completion date • Trial primary completion date • Combination therapy • Checkpoint inhibition • MSi-H Biomarker • PD(L)-1 Biomarker
    |
    PD-L1 (Programmed death ligand 1) • 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
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tecentriq (atezolizumab) • Imfinzi (durvalumab) • Bavencio (avelumab) • Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK
    over4years
    PD-L1 targeting high-affinity NK (t-haNK) cells induce direct antitumor effects and target suppressive MDSC populations. (PubMed, J Immunother Cancer)
    These studies demonstrate the antitumor efficacy of PD-L1 t-haNK cells and provide a rationale for the potential use of these cells in clinical studies.
    Clinical • Journal • PD(L)-1 Biomarker
    |
    PD-L1 (Programmed death ligand 1)
    |
    PD-L1 expression
    |
    Anktiva (nogapendekin alfa inbakicept-pmln) • PD-L1.t-haNK
    over4years
    [VIRTUAL] Quilt-3.064: An open-label phase I study of PD-L1 t-haNK in subjects with locally advanced or metastatic solid cancers. (ASCO 2020)
    Enrollment into Cohort 2 began December 2019. Research Funding: NantKwest
    Clinical • P1 data • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • FCGR3A (Fc Fragment Of IgG Receptor IIIa)
    |
    PD-L1 expression
    |
    PD-L1.t-haNK