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.

8 months ago

Enrollment change • Trial completion date • Trial termination • Trial primary completion date

GDA-201

over1year

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.

over 1 year ago

Journal

IL15 (Interleukin 15)

Rituxan (rituximab) • GDA-201

2years

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.

2 years ago

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

2years

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-

2 years ago

IO biomarker

NCAM1 (Neural cell adhesion molecule 1)

NCAM1 expression

GDA-201

2years

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

2 years ago

Trial completion • Enrollment change

CD20 (Membrane Spanning 4-Domains A1)

CD20 positive • CD20 expression

cyclophosphamide • GDA-201

2years

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.).

2 years ago

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

3years

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.

3 years ago

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

3years

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.

3 years ago

Clinical • IO biomarker

SELL (Selectin L)

Rituxan (rituximab) • cyclophosphamide • fludarabine IV • 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 | Suspended --> Recruiting

over 3 years ago

Enrollment open

CD20 (Membrane Spanning 4-Domains A1)

CD20 positive • CD20 expression

GDA-201

almost4years

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

almost 4 years ago

Clinical • Trial suspension

CD20 (Membrane Spanning 4-Domains A1)

CD20 positive • CD20 expression

GDA-201

4years

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

4 years ago

Clinical • Trial completion date • Trial primary completion date

CD20 (Membrane Spanning 4-Domains A1)

CD20 positive • CD20 expression

GDA-201