- |||||||||| Enrollment change, Trial completion date, Trial withdrawal, Trial primary completion date, Metastases: QUILT-3.072: NANT Hepatocellular Carcinoma (HCC) Vaccine (clinicaltrials.gov) - Aug 28, 2019
P1/2, N=0, Withdrawn, N=1064 --> 0 | Not yet recruiting --> Withdrawn N=382 --> 0 | Trial completion date: Dec 2022 --> Aug 2019 | Active, not recruiting --> Withdrawn | Trial primary completion date: Jul 2020 --> Aug 2019
- |||||||||| Empliciti (elotuzumab) / AbbVie, BMS
Trial completion date, Trial primary completion date: 2015-10: Expanded Natural Killer Cells and Elotuzumab for High-Risk Myeloma Post- Autologous Stem Cell Transplant (ASCT) (clinicaltrials.gov) - Aug 22, 2019 P2, N=10, Not yet recruiting, These findings indicate that ALT-803 can enhance ADCC activity mediated by NEO-201, by modulating NK activation and cytotoxicity, suggesting a possible clinical use of ALT-803 in combination with NEO-201 for the treatment of human carcinomas. Trial completion date: Aug 2019 --> Aug 2021 | Trial primary completion date: Aug 2019 --> Aug 2021
- |||||||||| Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Enrollment closed, Trial initiation date, Combination therapy, Checkpoint inhibition: QUILT-3.063: A Study of N-803, haNK and Avelumab in Patients With Merkel Cell Carcinoma That Has Progressed After Checkpoint Therapy (clinicaltrials.gov) - Aug 20, 2019 P2, N=43, Active, not recruiting, Trial completion date: Aug 2019 --> Aug 2021 | Trial primary completion date: Aug 2019 --> Aug 2021 Not yet recruiting --> Active, not recruiting | Initiation date: Jul 2019 --> Mar 2019
- |||||||||| Erbitux (cetuximab) / Eli Lilly, EMD Serono, ALT-803 / Altor BioScience, NantKwest
Journal: An IL-15-based superagonist ALT-803 enhances the NK cell response to cetuximab-treated squamous cell carcinoma of the head and neck. (Pubmed Central) - Aug 15, 2019 Administration of both cetuximab and ALT-803 to mice harboring Cal27 SCCHN tumors resulted in significantly decreased tumor volume when compared to controls and compared to single-agent treatment alone. Overall, the present data suggest that cetuximab treatment in combination with ALT-803 in patients with EGFR-positive SCCHN may result in significant NK cell activation and have important anti-tumor activity.
- |||||||||| Rituxan (rituximab) / Roche, Biogen
REGULATION OF THE FUNCTIONS OF EXPANDED NATURAL KILLER (NK) CELLS BY N-820, AN IL-15 SUPERAGONIST WITH 4 SINGLE-CHAIN ANTI-CD20 ANTIBODY DOMAINS AGAINST BURKITT LYMPHOMA (BL) (Poster Area) - Aug 7, 2019 - Abstract #SIOP2019SIOP_1499; N-820 was generated by fusing N-803 (ALT-803, IL-15 superagonist) to four single-chains of the tumor-targeting monoclonal antibody, rituximab (Liu/Wong, et al, JBC , 2016). N-820 significantly enhanced exPBNK cytotoxicity, IFN-g, granzyme B, GM-CSF release from exPBNK, inhibited CCL22 release from BL and increased anti-tumor activity against BL xenografted NSG mice.
- |||||||||| Anktiva (inbakicept) / ImmunityBio
Journal: Glycolytic requirement for NK cell cytotoxicity and cytomegalovirus control. (Pubmed Central) - Aug 1, 2019 Consistent with this, treatment of a patient with ALT-803 for recurrent CMV reactivation after hematopoietic cell transplant was associated with clearance of viremia. These studies demonstrate that NK cell-mediated control of viral infection requires glucose metabolism and that IL-15 treatment in vivo can reduce this requirement and may be effective as an antiviral therapy.
- |||||||||| Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Enrollment open, Enrollment change, Trial completion date, Trial primary completion date, Combination therapy: QUILT-2.005: A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer (clinicaltrials.gov) - Jul 23, 2019 P1/2, N=596, Recruiting, These studies demonstrate that NK cell-mediated control of viral infection requires glucose metabolism and that IL-15 treatment in vivo can reduce this requirement and may be effective as an antiviral therapy. Active, not recruiting --> Recruiting | N=256 --> 596 | Trial completion date: Oct 2019 --> Oct 2021 | Trial primary completion date: Jul 2019 --> Jul 2021
- |||||||||| doxycycline / generics
Journal: Regulatory effects of Interleukin (IL)-15 on allergen-induced airway obstruction. (Pubmed Central) - Jul 17, 2019 Active, not recruiting --> Recruiting | N=256 --> 596 | Trial completion date: Oct 2019 --> Oct 2021 | Trial primary completion date: Jul 2019 --> Jul 2021 We report our novel finding that IL-15 has a potent inhibitory effect on the airway obstruction that occurs in response to environmental allergens.
- |||||||||| Trial completion date, Trial primary completion date: QUILT-3.080: NANT Pancreatic Cancer Vaccine (clinicaltrials.gov) - Jul 15, 2019
P1b/2, N=173, Active, not recruiting, Trial primary completion date: May 2019 --> Dec 2019 Trial completion date: May 2020 --> Dec 2019 | Trial primary completion date: May 2019 --> Dec 2019
- |||||||||| Enrollment closed, Metastases: QUILT-3.071: QUILT 3.071: NANT Colorectal Cancer (CRC) Vaccine (clinicaltrials.gov) - May 17, 2019
P1b/2, N=332, Active, not recruiting, This immunostimulatory IL-15 superagonist warrants further investigation to augment anti-tumor immunity alone and combined with other immunotherapies. Recruiting --> Active, not recruiting
- |||||||||| Enrollment closed: QUILT-3.080: NANT Pancreatic Cancer Vaccine (clinicaltrials.gov) - May 13, 2019
P1b/2, N=173, Active, not recruiting, Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2018 --> May 2019 Recruiting --> Active, not recruiting
- |||||||||| Opdivo (nivolumab) / Ono Pharma, BMS, Anktiva (inbakicept) / ImmunityBio
Clinical, P1 data, Journal, Combination therapy: ALT-803, an IL-15 superagonist, in combination with nivolumab in patients with metastatic non-small cell lung cancer: a non-randomised, open-label, phase 1b trial. (Pubmed Central) - Apr 11, 2019 P1/2 ALT-803 in combination with nivolumab can be safely administered in an outpatient setting. The promising clinical activity observed with the addition of ALT-803 to the regimen of patients with PD-1 monoclonal antibody relapsed and refractory disease shows evidence of anti-tumour activity for a new class of agents in NSCLC.
- |||||||||| Anktiva (inbakicept) / NantWorks
Journal: An IL-15 superagonist/IL-15Rα fusion complex protects and rescues NK cell-cytotoxic function from TGF-β1-mediated immunosuppression. (Pubmed Central) - Mar 2, 2019 An interleukin (IL)-15 superagonist/IL-15 receptor α fusion complex (IL-15SA/IL-15RA; ALT-803) activates the IL-15 receptor on CD8 T cells and NK cells, and has shown significant anti-tumor activity in several in vivo studies...IL-15SA/IL-15RA blocked Smad2/3-induced transcription, resulting in the rescue of NK cell-cytotoxic function from TGF-β1-induced suppression. These findings suggest that in addition to increasing NK cell function via promoting the IL-15 signaling pathway, IL-15SA/IL-15RA can function as an inhibitor of TGF-β1 signaling, providing a potential remedy for NK cell dysfunction in the immunosuppressive tumor microenvironment.
- |||||||||| PD-L1.t-haNK / ImmunityBio, Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Enrollment change, Trial completion date, Trial initiation date, Trial primary completion date, Checkpoint inhibition, MSi-H Biomarker, PD(L)-1 Biomarker: QUILT-3.055: a Study of Combination Immunotherapies in Patients Who Have Previously Received Treatment with Immune Checkpoint Inhibitors (clinicaltrials.gov) - Feb 8, 2019 P2b, N=611, Recruiting, These findings suggest that in addition to increasing NK cell function via promoting the IL-15 signaling pathway, IL-15SA/IL-15RA can function as an inhibitor of TGF-β1 signaling, providing a potential remedy for NK cell dysfunction in the immunosuppressive tumor microenvironment. N=105 --> 611 | Trial completion date: Aug 2022 --> Aug 2020 | Initiation date: Jun 2018 --> Dec 2018 | Trial primary completion date: May 2021 --> Jun 2020
- |||||||||| Anktiva (inbakicept) / NantWorks
Journal, PD(L)-1 Biomarker, IO biomarker: The multi-functionality of N-809, a novel fusion protein encompassing anti-PD-L1 and the IL-15 superagonist fusion complex. (Pubmed Central) - Feb 5, 2019 This molecule comprises the IL-15/IL15Rα superagonist complex containing the Fc-domain of IgG1 (N-803, formerly designated as ALT-803) fused to two single chain anti-PD-L1 domains...Similarly, the highest level of ADCC was seen when both NK cells (from donors or cancer patients) and tumor cells were exposed to N-809. These studies thus demonstrate the multi-functionality of this novel agent.
|