- |||||||||| Anktiva (inbakicept) / ImmunityBio
Enrollment closed, Enrollment change, Trial completion date: Relapse Prophylaxis With N-803 for AML and MDS Pts Following Allo HSCT (clinicaltrials.gov) - Feb 28, 2022 P2, N=20, Active, not recruiting, No abstract available Recruiting --> Active, not recruiting | N=60 --> 20 | Trial completion date: Jan 2022 --> Jan 2023
- |||||||||| teropavimab (GS-5423) / Rockefeller University, Gilead, zinlirvimab (GS-2872) / National Institute of Allergy and Infectious Diseases, Rockefeller University, Gilead
New P1 trial: 3BNC117-LS and 10-1074-LS Plus N-803 (bNAb+N-803) (clinicaltrials.gov) - Feb 17, 2022 P1, N=36, Not yet recruiting,
- |||||||||| Anktiva (inbakicept) / ImmunityBio
Review, Journal: Therapeutic Potential of IL-15 and N-803 in HIV/SIV Infection. (Pubmed Central) - Feb 12, 2022 N-803 has also been evaluated in "shock and kill" strategies due to its potential to reverse latency (shock) and enhance antiviral immunity (kill). This review examines the current literature about the effects of IL-15 and N-803 on innate and cellular immunity, viral burden, and latency reversal in the context of HIV/SIV, and their therapeutic potential both alone and combined with additional interventions such as antiretroviral therapy (ART) and vaccination.
- |||||||||| bempegaldesleukin (NKTR-214) / Nektar Therap, BMS, Ono Pharma, Anktiva (inbakicept) / ImmunityBio, pegilodecakin (LY3500518) / Eli Lilly
Review, Journal: Cytokines in the Treatment of Melanoma. (Pubmed Central) - Jan 29, 2022 The safety and the anti-tumor activity of newly engineered cytokines including PEGylated IL-2 (NKTR-214), PEGylated IL-10 (AM0010), and IL-15 super agonist (ALT-803) have been evaluated in clinical trials with encouraging clinical activity and acceptable safety profile, both as single agents and in combination with immuno-oncology agents. A greater understanding of the mechanisms of action and effective dosing of these newly engineered cytokine together with determination of optimum combination therapy regimens may yield greater clinical benefits in the future.
- |||||||||| CIML NK cells / Washington University School of Medicine in St. Louis
Trial completion date, Trial primary completion date: Cytokine-induced Memory-like NK Cells in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) (clinicaltrials.gov) - Jan 28, 2022 P1/2, N=140, Recruiting, A greater understanding of the mechanisms of action and effective dosing of these newly engineered cytokine together with determination of optimum combination therapy regimens may yield greater clinical benefits in the future. Trial completion date: Sep 2028 --> Sep 2029 | Trial primary completion date: Sep 2023 --> Sep 2024
- |||||||||| 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) - Jan 25, 2022 P1/2, N=113, Recruiting, Trial completion date: Sep 2028 --> Sep 2029 | Trial primary completion date: Sep 2023 --> Sep 2024 Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023
- |||||||||| 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) - Jan 12, 2022 P1, N=46, Recruiting, Our results provide the rationale for the development of a clinical trial of N-803 in combination with dinutuximab and ex vivo exPBNK cells in patients with recurrent or metastatic GD2 solid tumors. Trial completion date: Aug 2023 --> Nov 2024 | Trial primary completion date: Sep 2022 --> Jan 2024
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Trial suspension, Metastases: 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) - Dec 28, 2021 P2, N=55, Suspended, Durable responses were noted in both cohorts and the therapy resulted in significant avoidance of cystectomy with a cystectomy free rate of 92% and a 24 month cancer specific survival of 99.5% Given the observed strong efficacy and favorable AE profile and mode of administration, N-803 represents a significant advance in the treatment option compared to existing therapies for BCG unresponsive CIS and Papillary NMIBC. Recruiting --> Suspended
- |||||||||| docetaxel / Generic mfg.
Journal, Tumor Mutational Burden, PD(L)-1 Biomarker, IO biomarker: Differential combination immunotherapy requirements for inflamed (warm) tumors versus T cell excluded (cool) tumors: engage, expand, enable, and evolve. (Pubmed Central) - Dec 17, 2021 Suspended --> Recruiting | N=14 --> 80 The hexatherapy regimen is a strategic combination of immuno-oncology agents that can engage, expand, enable, and evolve the immune response and can provide therapeutic benefits in both MC38-CEA (warm) and 4T1 (cool) tumor models.
- |||||||||| Anktiva (inbakicept) / ImmunityBio
Journal, IO biomarker: Therapy of Established Tumors with Rationally Designed Multiple Agents Targeting Diverse Immune-Tumor Interactions: Engage, Expand, Enable. (Pubmed Central) - Dec 16, 2021 To target these distinct phenomena, we strategically chose five clinical-stage immuno-oncology agents, namely, (i) a tumor antigen-targeting adenovirus-based vaccine (Ad-CEA) and an IL15 superagonist (N-803) to activate tumor-specific T cells, (ii) OX40 and GITR agonists to expand and enhance the activated effector populations, and (iii) an IDO inhibitor (IDOi) to enable effector-cell activity in the TME...The pentatherapy combination also inhibited tumor growth and metastatic formation in 4T1 and LL2-CEA murine tumor models. This study provides the rationale for the combination of multi-modal immunotherapy agents to engage, enhance, and enable adaptive antitumor immunity.
- |||||||||| bintrafusp alfa (M7824) / EMD Serono, epacadostat (INCB024360) / Incyte, Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Enrollment open, Enrollment change: Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1) (clinicaltrials.gov) - Dec 8, 2021 P1/2, N=113, Recruiting, This study provides the rationale for the combination of multi-modal immunotherapy agents to engage, enhance, and enable adaptive antitumor immunity. Suspended --> Recruiting | N=46 --> 113
- |||||||||| bintrafusp alfa (M7824) / EMD Serono, Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Enrollment closed, Trial completion date, Trial primary completion date, Combination therapy: Anti-PD-L1/TGF-beta Trap (M7824) Alone and in Combination With TriAd Vaccine and N-803 for Resectable Head and Neck Squamous Cell Carcinoma Not Associated With Human Papillomavirus Infection (clinicaltrials.gov) - Dec 6, 2021 P1/2, N=8, Active, not recruiting, Trial completion date: Dec 2022 --> May 2022 | Trial primary completion date: Dec 2021 --> Mar 2022 Suspended --> Active, not recruiting | Trial completion date: Dec 2022 --> Jun 2023 | Trial primary completion date: Aug 2022 --> Jun 2023
- |||||||||| Journal: Immunotherapy of high risk non-muscle invasive bladder cancer. (Pubmed Central) - Nov 6, 2021
While BCG is likely to remain a primary medication for high grade bladder cancer for the near future, BCG will likely be co-administered with immunomodulatory medications in some patients to enhance the medications effect in the future. Clinical trials are still ongoing and will demonstrate which of these multiple treatment options yield results worthy of a modification in our current treatment paradigm.
- |||||||||| Anktiva (inbakicept) / ImmunityBio
Cytokine-Induced Memory-like NK Cells Have a Distinct Single Cell Transcriptional Profile and Persist for Months in Adult and Pediatric Leukemia Patients after Adoptive Transfer (GWCC - Hall B5, Level 1) - Nov 5, 2021 - Abstract #ASH2021ASH_5523; P1/2, P2 To address this limitation, we conducted a clinical trial for rel/ref AML patients that added adoptive transfer of same-donor ML NK cells on day +7 of a reduced-intensity conditioning (RIC) MHC-haploidentical HCT, followed by 4 doses of IL-15 (N-803) over 2 weeks (NCT02782546)...Thus, ML NK cells possess a distinct transcriptional and surface proteomic profile and undergo in vivo differentiation while persisting within patients for at least 2 months. These findings reveal novel and unique aspects of the ML NK cell molecular program, as well as their prolonged functional persistence in vivo in patients, assisting in future clinical trial design.
- |||||||||| Cyramza (ramucirumab) / Eli Lilly, Anktiva (inbakicept) / ImmunityBio, Tecentriq (atezolizumab) / Roche
Enrollment change, Trial withdrawal, Checkpoint inhibition, Checkpoint block: RAN: Ramucirumab, Atezolizumab and N-803 After Progression on Any Immune Checkpoint Blocker in NSCLC (clinicaltrials.gov) - Nov 4, 2021 P2, N=0, Withdrawn, These findings reveal novel and unique aspects of the ML NK cell molecular program, as well as their prolonged functional persistence in vivo in patients, assisting in future clinical trial design. N=21 --> 0 | Not yet recruiting --> Withdrawn
- |||||||||| Bavencio (avelumab) / EMD Serono, Pfizer, Abraxane (albumin-bound paclitaxel) / BMS, Otsuka, Anktiva (inbakicept) / ImmunityBio
Clinical, Journal: Complete response to avelumab and IL-15 superagonist N-803 with Abraxane in Merkel cell carcinoma: a case study. (Pubmed Central) - Oct 16, 2021 Abraxane was discontinued after the first CR on CT, and the patient continues on avelumab/N-803 treatment and maintains a CR. Combination of avelumab with low/moderate-dose chemotherapy and an immune enhancer such as N-803 may offer a viable treatment option for MCC patients for whom avelumab therapy alone was not effective.
- |||||||||| Anktiva (nogapendekin alfa inbakicept-pmln) / ImmunityBio
Enrollment change, Trial completion date, Trial termination, Trial primary completion 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) - Oct 8, 2021 P2, N=9, Terminated, Not yet recruiting --> Recruiting N=43 --> 9 | Trial completion date: Mar 2022 --> Oct 2021 | Recruiting --> Terminated | Trial primary completion date: Mar 2022 --> Oct 2021; Not meeting recruitment goal
- |||||||||| Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche, Anktiva (inbakicept) / ImmunityBio
Preclinical, Journal, IO biomarker: Novel cytokine-antibody fusion protein, N-820, to enhance the functions of ex vivo expanded natural killer cells against Burkitt lymphoma. (Pubmed Central) - Oct 7, 2021 N=43 --> 9 | Trial completion date: Mar 2022 --> Oct 2021 | Recruiting --> Terminated | Trial primary completion date: Mar 2022 --> Oct 2021; Not meeting recruitment goal Our results provide the rationale for the development of a clinical trial of N-820 alone or in combination with endogenous or ex vivo expanded NK cells in patients with CD20 B-NHL failing prior rituximab containing chemoimmunotherapy regimens.
|