- |||||||||| bintrafusp alfa (M7824) / EMD Serono, epacadostat (INCB024360) / Incyte, Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Enrollment closed, Enrollment change: Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1) (clinicaltrials.gov) - Apr 17, 2024 P1/2, N=53, Active, not recruiting, Evaluation of tumor and patient characteristics will be critical to define if there are those who may benefit from N-803 plus pembrolizumab. Recruiting --> Active, not recruiting | N=113 --> 53
- |||||||||| Review, Journal: Revolutionizing Treatment: Breakthrough Approaches for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer. (Pubmed Central) - Apr 13, 2024
Other, less researched therapeutic possibilities are also included, namely: N-803 immunotherapy, TAR-200 and TAR-210 intravesical delivery systems and combined Cabazitaxel, Gemcitabine and Cisplatin chemotherapy. Conservative treatment and delaying radical cystectomy would greatly benefit patients' quality of life; it is undoubtedly the future of BCG-unresponsive NMIBC.
- |||||||||| bintrafusp alfa (M7824) / EMD Serono, Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Enrollment change, Trial completion date, Trial withdrawal, Trial primary completion date, Combination therapy: N-803 Alone or in Combination With BN-Brachyury Vaccine or Bintrafusp Alfa (M7824) for Participants With Castration Resistant Prostate Cancer (clinicaltrials.gov) - Apr 4, 2024 P2, N=0, Withdrawn, Recruiting --> Active, not recruiting N=28 --> 0 | Trial completion date: Aug 2026 --> Apr 2024 | Not yet recruiting --> Withdrawn | Trial primary completion date: Nov 2024 --> Apr 2024
- |||||||||| CD19.t-haNK / ImmunityBio, Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Trial completion date, Trial primary completion date, Combination therapy: Study for Subjects With Relapsed/Refractory Non- Hodgkin Lymphoma (clinicaltrials.gov) - Jan 28, 2024 P1, N=20, Not yet recruiting, Trial completion date: Jul 2024 --> Apr 2026 | Trial primary completion date: Jul 2024 --> Oct 2025 Trial completion date: Sep 2026 --> Mar 2027 | Trial primary completion date: Sep 2024 --> Mar 2026
- |||||||||| Tri-Ad5 / ImmunityBio, Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Phase classification: Testing a Combination of Vaccines for Cancer Prevention in Lynch Syndrome (clinicaltrials.gov) - Jan 23, 2024 P2, N=186, Recruiting, Trial completion date: Sep 2026 --> Mar 2027 | Trial primary completion date: Sep 2024 --> Mar 2026 Phase classification: P2b --> P2
- |||||||||| CIML NK - Dana / Farber Cancer Institute
Trial completion date, Trial primary completion date, Combination therapy, Metastases, Immune cell: CIML NK Cell in Head & Neck Cancer (clinicaltrials.gov) - Jan 17, 2024 P1, N=25, Recruiting, Recruiting --> Active, not recruiting Trial completion date: Mar 2024 --> Jul 2024 | Trial primary completion date: Jan 2024 --> Jun 2024
- |||||||||| PD-L1.t-haNK / ImmunityBio, Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Trial completion date, Trial initiation date, Trial primary completion date: N-803 and PD-L1 t-haNK Combined With Bevacizumab for Recurrent or Progressive Glioblastoma (clinicaltrials.gov) - Dec 18, 2023 P2, N=20, Not yet recruiting, The overall stability of PROs scores taken together with the efficacy findings, indicate a favorable risk/benefit ratio and quality of life following N-803 plus BCG. Trial completion date: Dec 2029 --> Dec 2030 | Initiation date: Nov 2023 --> Feb 2024 | Trial primary completion date: Dec 2028 --> Dec 2029
- |||||||||| Anktiva (inbakicept) / ImmunityBio
IL15 (N-803) and IL21 (oHSV-21) Significantly Enhance ROR1 CAR NK Cells Against Pediatric Neuroblastoma () - Dec 11, 2023 - Abstract #TCTASTCTCIBMTR2024TCT_ASTCT_CIBMTR_1267; The N-803 combined with dinutuximab and exPBNK cells significantly extended the survival of NB xenografts (Chu/Cairo, et al, JITC...C021 was generated by modifying C134 to express human IL21 gene... Our data demonstrated IL15 or IL21 based novel cytokine therapy (N-803 or C021) significantly enhanced the anti-tumor efficacy of ROR1 CAR NK targeting NB in vitro and in vivo (Funded by U54 CA232561).
- |||||||||| bintrafusp alfa (M7824) / EMD Serono, epacadostat (INCB024360) / Incyte, Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Trial completion date, Trial primary completion date: Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1) (clinicaltrials.gov) - Dec 10, 2023 P1/2, N=113, Recruiting, Our data demonstrated IL15 or IL21 based novel cytokine therapy (N-803 or C021) significantly enhanced the anti-tumor efficacy of ROR1 CAR NK targeting NB in vitro and in vivo (Funded by U54 CA232561). Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
- |||||||||| CIML NK - Dana / Farber Cancer Institute, Anktiva (inbakicept) / ImmunityBio, Yervoy (ipilimumab) / Ono Pharma, BMS
CTLA-4 Blockade Leads to Enrichment of Active CD56dimCD16+ NK Cells and Depletion of Regulatory T Cells Following Infusion of Haploidentical Donor Memory-like Natural Killer Cells Plus IL-15 Superagonist in a Phase 1 Trial (Stars at Night B2 & B3 (Ballroom Level, Henry B. Gonzalez Convention Center); in-person) - Dec 5, 2023 - Abstract #TCTASTCTCIBMTR2024TCT_ASTCT_CIBMTR_702; P1 We, therefore, hypothesized the use of CTLA-4 blockade with ipilimumab (IPI) would deplete Tregs in vivo and thus allow enhanced proliferation, activation, and anti-tumor responses of the adoptively transferred CIML NK cells...All patients received lymphodepletion with fludarabine (25 mg/m2 x 5 days) and cyclophosphamide (60 mg/kg x 2 days) and haploidentical CIML NK cell infusion (5-10 x 106 cells/kg) followed by IL-15 superagonist (N-803) (15 mcg/kg subcutaneously) starting on day +1 every 21-days (4x)...The use of IPI was associated with a relative depletion of Tregs with concurrent expansion of CD56dimCD16+ NK cells that had enrichment of proliferative (MYC), metabolically active (mTORC1), and cytokine reactive (TNFa) gene sets. Further work is required to elucidate the mechanism by which IPI exposure is associated with the expansion of specific subsets of CIML NK cells.
- |||||||||| teropavimab (GS-5423) / Rockefeller University, Gilead, zinlirvimab (GS-2872) / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead
Trial primary completion date: 3BNC117-LS and 10-1074-LS Plus N-803 (bNAb+N-803) (clinicaltrials.gov) - Oct 24, 2023 P1, N=36, Recruiting, Trial primary completion date: Nov 2023 --> Nov 2024 Trial primary completion date: Dec 2024 --> Dec 2025
- |||||||||| CIML NK - Dana / Farber Cancer Institute
Trial primary completion date, Combination therapy, Metastases, Immune cell: CIML NK Cell in Head & Neck Cancer (clinicaltrials.gov) - Oct 17, 2023 P1, N=25, Recruiting, Trial primary completion date: Dec 2024 --> Dec 2025 Trial primary completion date: Sep 2023 --> Jan 2024
- |||||||||| Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Targeted mRNA?LNP encoding IL?15 superagonist complex achieves a delicate balance between efficacy and toxicity in cancer therapy () - Oct 15, 2023 - Abstract #ESGCT2023ESGCT_620; Further investigation revealed that the anti?tumor effect was mainly mediated through the promotion of proliferation and activation of CD8+ T cells and NK cells. This finding highlights a promising strategy for cytokine?based cancer therapy, achieving a favorable balance between efficacy and safety through the mRNA?LNP platform.Key words: Interleukin?15; mRNA?LNP; Lung?targeted delivery; Melanoma metastasis; Cytokines therapy
- |||||||||| Anktiva (inbakicept) / ImmunityBio
Review, Journal: IL-15 and N-803 for HIV Cure Approaches. (Pubmed Central) - Sep 28, 2023 They have been shown to reactivate latent HIV and enhance immune effector function, both of which are potentially required for effective reduction of latent reservoirs. In here, we present a comprehensive literature review of the different in vitro, ex vivo, and in vivo studies conducted to date that are aimed at targeting HIV reservoirs using IL-15 and N-803.
- |||||||||| Anktiva (inbakicept) / ImmunityBio
Characterization of the anti-tumor activity of memory cytokine enriched NK cells against tumors with neuroendocrine features (Exhibit Hall B) - Sep 27, 2023 - Abstract #SITC2023SITC_722; Studies suggest that a lack of response to ICB is partially attributable to low expression of MHC-class I. In a recent report, our group found that the lack of MHC-class I can be utilized to enable targeting by NK cells stimulated with an IL-15 cytokine superagonist (N-803)...In the future, we aim to expand evaluation of the efficacy of M-ceNK to target additional tumor types that are refractory to ICB. Additional studies are ongoing to determine the contribution of low MHC-class I or other tumor ligands to the mechanism of action enabling lysis by M-ceNK in the context of NE tumor models.
- |||||||||| 10-1074 / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead, VRC07-523LS / National Institute of Allergy and Infectious Diseases, IAVI, TaiMed Biologics
Trial completion date, Trial primary completion date: Safety, Tolerability, and Efficacy of IL-15 Superagonist (N-803) With and Without Combination Broadly Neutralizing Antibodies to Induce HIV-1 Control During Analytic Treatment Interruption (clinicaltrials.gov) - Sep 11, 2023 P1, N=46, Recruiting, Additional studies are ongoing to determine the contribution of low MHC-class I or other tumor ligands to the mechanism of action enabling lysis by M-ceNK in the context of NE tumor models. Trial completion date: Nov 2024 --> Apr 2026 | Trial primary completion date: Jan 2024 --> Oct 2025
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