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    DRUG:

    GDA-201

    i
    Other names: GDA-201, NAM NK cells, nicotinamide expanded haploidentical or mismatched related donor natural killer cells
    Associations

    News

    Trials
    Company:
    Gamida Cell
    Drug class:
    NK cell stimulant
    Related drugs:
    Associations

    News

    Trials
    14d
    Evaluation of Safety and Efficacy of Allo GDA-201 NK Cells in Patients With Relapsed/Refractory B Cell NHL (clinicaltrials.gov)
    P1/2, N=13, Terminated, Gamida Cell ltd | N=99 --> 13 | Trial completion date: Mar 2025 --> Apr 2024 | Recruiting --> Terminated | Trial primary completion date: Aug 2024 --> Apr 2024; Study terminated by Sponsor.
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
    |
    GDA-201
    10ms
    Nicotinamide enhances natural killer cell function and yields remissions in patients with non-Hodgkin lymphoma. (PubMed, Sci Transl Med)
    Cellular therapy with GDA-201 and rituximab was well tolerated and yielded an overall response rate of 74% in 19 patients with advanced NHL. GDA-201 cells were detected for up to 14 days in blood, bone marrow, and tumor tissues and maintained a favorable metabolic profile. The safety and efficacy of GDA-201 in this study support further development as a cancer therapy.
    Journal
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    IL15 (Interleukin 15)
    |
    Rituxan (rituximab) • GDA-201
    over1year
    Tumor Microenvironment Spatial Analysis after Adoptive NK Cell Therapy for Lymphoma Revealed Cross-Talk with Adaptive T-Cell Immunity (TCT-ASTCT-CIBMTR 2023)
    All patients received lymphodepleting chemotherapy followed by 2 infusions of GDA-201 at days 0 and 2 combined with rituximab and low dose IL2. Overall, our findings from multiplexed spatial profiling support a model in which adoptive NK cell infusions trigger profound immune microenvironment changes which support the influx of host T cells. This occurs early post GDA-201 infusion concurrent with limited blood compartment persistence. Our findings suggest cross-talk with the adaptive arm of the immune system and effective tumor elimination.
    IO biomarker
    |
    CD8 (cluster of differentiation 8) • IL2RA (Interleukin 2 receptor, alpha) • CD4 (CD4 Molecule) • IL15 (Interleukin 15) • IL7 (Interleukin 7)
    |
    Rituxan (rituximab) • GDA-201
    over1year
    Gda-201: A Cryopreserved, Readily Available Formulation of Nicotinamide-Enabled Natural Killer Cells, Shows Increased Potency and Enhanced Cytotoxicity (TCT-ASTCT-CIBMTR 2023)
    Cells maintained expression of CD56 and CD16 and expressed high levels of the homing and retention marker CD62L. Cryopreserved GDA-201 showed high cytotoxicity and enhanced potency as detected by intracellular secretion of IFN-
    IO biomarker
    |
    NCAM1 (Neural cell adhesion molecule 1)
    |
    NCAM1 expression
    |
    GDA-201
    over1year
    Ph I Trial of NAM NK Cells and IL-2 for Adult Pts With MM and NHL (clinicaltrials.gov)
    P1, N=39, Completed, Masonic Cancer Center, University of Minnesota | Recruiting --> Completed | N=24 --> 39
    Trial completion • Enrollment change
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 positive • CD20 expression
    |
    cyclophosphamide • GDA-201
    over1year
    GDA-501: Engineered NAM-NK cells with HER2-CAR expression demonstrate increased cytotoxicity against HER2-expressing solid tumors (SITC 2022)
    Methods HER2-CAR-NK cells were developed based on a single-chain variable fragment (scFv) of the widely used humanized monoclonal antibody trastuzumab. Informed consent has been approved by the ECs. The Israeli template of informed consent is in used and it includes study specific information (e.g. study goal, design, method, duration, risks, etc.).
    IO biomarker
    |
    HER-2 (Human epidermal growth factor receptor 2) • TNFA (Tumor Necrosis Factor-Alpha) • LAMP1 (Lysosomal Associated Membrane Protein 1)
    |
    HER-2 expression • HER-2 elevation
    |
    Herceptin (trastuzumab) • GDA-501 • GDA-201
    over2years
    Transcriptional and Metabolic Profiling of Nicotinamide-Enhanced Natural Killer (NAM-NK) Cells (GDA-201) (ASH 2021)
    Moreover, NAM increases cellular metabolic fitness, energy charge, and efficiency of glucose consumption, potentially imparting a protective effect against oxidative stress in the tumor microenvironment. These data offer insight into the mechanism of improved persistence, proliferation, and cytotoxicity observed in in vivo and clinical studies of GDA-201.
    IO biomarker
    |
    MDM2 (E3 ubiquitin protein ligase) • LAG3 (Lymphocyte Activating 3) • CDK4 (Cyclin-dependent kinase 4) • IL2RA (Interleukin 2 receptor, alpha) • CD44 (CD44 Molecule) • FOXP1 (Forkhead Box P1) • CALR (Calreticulin) • RPS6 (Ribosomal Protein S6) • STAT1 (Signal Transducer And Activator Of Transcription 1) • CD40LG (CD40 ligand) • CXCR3 (C-X-C Motif Chemokine Receptor 3) • GATA3 (GATA binding protein 3) • HSPH1 (Heat Shock Protein Family H (Hsp110) Member 1) • CD86 (CD86 Molecule) • HSP90AA1 (Heat Shock Protein 90 Alpha Family Class A Member 1Heat Shock Protein 90 Alpha Family Class A Member 1) • PABPC1 (Poly(A) Binding Protein Cytoplasmic 1)
    |
    GDA-201
    over2years
    Gda-201, a Novel Metabolically Enhanced Allogeneic Natural Killer (NK) Cell Product Yields High Remission Rates in Patients with Relapsed/Refractory Non-Hodgkin Lymphoma (NHL): 2-Year Survival and Correlation with Cytokine IL7 (ASH 2021)
    Pts with R/R B-cell NHL received lymphodepleting (LD) chemotherapy with cyclophosphamide (400mg/m 2 IV x 3d) and fludarabine (30 mg/m 2 /d IV x 3d), followed by GDA-201 (days 0 and 2) and low-dose IL-2 (6 million units sc x 3 doses at days 0,2,4). Cellular therapy using GDA-201 with rituximab is well-tolerated, and demonstrated significant clinical activity in heavily pre-treated pts with advanced NHL. A cytokine surge following LD chemotherapy appears to be associated with clinical activity. Phase II studies in aggressive and indolent NHL cohorts are planned.
    Clinical • IO biomarker
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    SELL (Selectin L)
    |
    Rituxan (rituximab) • cyclophosphamide • fludarabine IV • GDA-201
    almost3years
    Ph I Trial of NAM NK Cells and IL-2 for Adult Pts With MM and NHL (clinicaltrials.gov)
    P1, N=24, Recruiting, Masonic Cancer Center, University of Minnesota | Suspended --> Recruiting
    Enrollment open
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 positive • CD20 expression
    |
    GDA-201
    over3years
    Ph I Trial of NAM NK Cells and IL-2 for Adult Pts With MM and NHL (clinicaltrials.gov)
    P1, N=24, Suspended, Masonic Cancer Center, University of Minnesota | Recruiting --> Suspended
    Clinical • Trial suspension
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 positive • CD20 expression
    |
    GDA-201
    over3years
    Ph I Trial of NAM NK Cells and IL-2 for Adult Pts With MM and NHL (clinicaltrials.gov)
    P1, N=24, Recruiting, Masonic Cancer Center, University of Minnesota | Trial completion date: Mar 2021 --> Sep 2022 | Trial primary completion date: Sep 2020 --> Sep 2022
    Clinical • Trial completion date • Trial primary completion date
    |
    CD20 (Membrane Spanning 4-Domains A1)
    |
    CD20 positive • CD20 expression
    |
    GDA-201