- |||||||||| Breyanzi (lisocabtagene maraleucel) / BMS, avipendekin pegol (NKTR-255) / Nektar Therap
Enhanced CAR T (Cinema Corso) - May 4, 2025 - Abstract #ICML2025ICML_1083;
- |||||||||| avipendekin pegol (NKTR-255) / Nektar Therap
Chemokine engineering significantly enhanced migration and tumor infiltration of ex vivo-expanded natural killer cells in osteosarcoma (Section 37; Poster Board No: 3) - Mar 25, 2025 - Abstract #AACR2025AACR_3201; To evaluate NK cell tumor infiltration, we injected human NK cells with an IL-15 agonist, NKTR-255, and harvested and dissociated tumors 5-7 days after NK injection for flow cytometry analysis...Our in vitro and in vivo data demonstrated that secretion of CXCL9, -10, and -11 from OS significantly enhanced NK migration and NK infiltration into the OS TME. We are actively investigating the in vivo anti-tumor efficacy of expanded NK cells against CXCL9, -10, or -11-secreting disseminated OS tumors.
- |||||||||| avipendekin pegol (NKTR-255) / Nektar Therap
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: NKTR-255 vs Placebo Following CD19-directed CAR-T Therapy in Patients With Relapsed/Refractory Large B-cell Lymphoma (clinicaltrials.gov) - Feb 13, 2025 P2/3, N=15, Terminated, We are actively investigating the in vivo anti-tumor efficacy of expanded NK cells against CXCL9, -10, or -11-secreting disseminated OS tumors. N=400 --> 15 | Trial completion date: Jan 2029 --> Aug 2024 | Recruiting --> Terminated | Trial primary completion date: Jan 2027 --> May 2024; Sponsor decided to end the study
- |||||||||| Anti-MCAM CAR NK / New York Medical College, avipendekin pegol (NKTR-255) / Nektar Therap
Combinatorial Immunotherapy of Mcam Targeting Chimeric Antigen Receptor Modified Expanded Natural Killer Cells and IL-15 Agonist Against Neuroblastoma (HCC Ballroom C; In-Person) - Dec 19, 2024 - Abstract #TCTASTCTCIBMTR2025TCT_ASTCT_CIBMTR_1366; Combination with NKTR-255 further enhanced the anti-tumor effects of CAR NK cells (p < 0.001 compared to vehicle control, p < 0.05 compared to CAR NK), and further prolonged animal survival (100% vs 30% survival at day 126 compared to CAR NK, p < 0.05) (Fig 1D, E). Conclusions Our studies demonstrate that ex vivo expanded and modified anti-MCAM CAR NK cells alone and/or in combination with NKTR-255 are promising novel alternative therapeutic approaches to targeting MCAM high malignant NB.
- |||||||||| Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma, avipendekin pegol (NKTR-255) / Nektar Therap
Targeting Ewing Sarcoma By IL1RAP CAR Modified Ex-Vivo Expanded TGF? Imprinted NK Cells in Combination with IL-15 Agonist and Anti-GD2 Antibody (HCC 313 ABC; In-Person) - Dec 19, 2024 - Abstract #TCTASTCTCIBMTR2025TCT_ASTCT_CIBMTR_728; Conclusions Our data demonstrated enhanced anti-tumor efficacy of IL1RAP CAR NK/TGF?i-NK cells alone and combined with NKTR-255 and dinutuximab against ES in vitro and in vivo. These CAR engineered TGF?i NK cells in combination with NK function and persistence enhancing immune modulators constitute potential novel effective immunotherapies for patients with high-risk ES.
- |||||||||| C-TIL051 / AbelZeta Pharma
Enrollment open, Metastases: C-TIL051 in Non-Small Cell Lung Cancer (clinicaltrials.gov) - Mar 1, 2024 P1, N=20, Recruiting, Phase classification: P1b/2 --> P1/2 Not yet recruiting --> Recruiting
- |||||||||| C-TIL051 / AbelZeta Pharma
Trial completion date, Trial primary completion date, Metastases: C-TIL051 in Non-Small Cell Lung Cancer (clinicaltrials.gov) - Dec 31, 2023 P1, N=20, Not yet recruiting,
- |||||||||| Unituxin (dinutuximab) / United Therapeutics Corp, Ohara Pharma, NKTR-255 / Nektar Therap
Targeting Ewing Sarcoma By Genetically and Epigenetically Modified Ex-Vivo Expanded NK Cells in Combination with NKTR-255 and Dinutuximab (221 (Meeting Level, Henry B. Gonzalez Convention Center); in-person) - Dec 11, 2023 - Abstract #TCTASTCTCIBMTR2024TCT_ASTCT_CIBMTR_739; Conclusions Our data demonstrated enhanced anti-tumor efficacy of modified NK (IL1RAP CAR NK, TGF?i-NK, IL1RAP CAR CXCR2 NK) cells alone and combined with NKTR-255 and dinutuximab against ES in vitro. This provided a rationale for a preclinical evaluation of the anti-tumor effects of these modified NK cells combined with NKTR-255 and dinutuximab in vivo.
- |||||||||| C-TIL051 / AbelZeta Pharma
Trial initiation date, Metastases: C-TIL051 in Non-Small Cell Lung Cancer (clinicaltrials.gov) - Sep 15, 2023 P1, N=20, Not yet recruiting, Mechanisms studies of BL relapsed from the combination therapy are under investigation. Initiation date: Mar 2023 --> Dec 2023
- |||||||||| NKTR-255 / Nektar Therap
Trial completion, Enrollment change, Trial completion date, Combination therapy, Monotherapy: Study of NKTR 255 in Combination With Cetuximab in Solid Tumors (clinicaltrials.gov) - May 16, 2023 P1b/2, N=25, Completed, Not yet recruiting --> Recruiting | Initiation date: Apr 2023 --> Jan 2023 Active, not recruiting --> Completed | N=326 --> 25 | Trial completion date: Aug 2024 --> Mar 2023
- |||||||||| NKTR-255 / Nektar Therap
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: NKTR-255 in Relapsed/Refractory Multiple Myeloma & Non-Hodgkin Lymphoma (clinicaltrials.gov) - Apr 12, 2023 P1, N=30, Active, not recruiting, Active, not recruiting --> Completed | N=326 --> 25 | Trial completion date: Aug 2024 --> Mar 2023 Enrolling by invitation --> Active, not recruiting | N=118 --> 30 | Trial completion date: Oct 2023 --> Jun 2023 | Trial primary completion date: Mar 2023 --> Jun 2023
- |||||||||| NKTR-255 / Nektar Therap
Enrollment closed, Combination therapy, Monotherapy: Study of NKTR 255 in Combination With Cetuximab in Solid Tumors (clinicaltrials.gov) - Mar 17, 2023 P1b/2, N=326, Active, not recruiting, Enrolling by invitation --> Active, not recruiting | N=118 --> 30 | Trial completion date: Oct 2023 --> Jun 2023 | Trial primary completion date: Mar 2023 --> Jun 2023 Recruiting --> Active, not recruiting
- |||||||||| NKTR-255 / Nektar Therap
Early Results of a Phase I Study of CAR-T Cells + NKTR-255 (PEG-IL-15) in Adults with R/R ALL () - Dec 16, 2022 - Abstract #TCTASTCTCIBMTR2023TCT_ASTCT_CIBMTR_903; P1 NKTR-255 administered at 1.5mcg/kg following CAR-T cell therapy was safe and appeared to promote CAR expansion in CNS and peripheral blood. Dose escalation is ongoing; additional safety data and longitudinal correlative assessments, including qPCR and cytokine data, will be presented at the meeting.
- |||||||||| Bavencio (avelumab) / EMD Serono, Pfizer
JAVELIN Bladder Medley: a phase 2 trial of avelumab in combination with other antitumor drugs as first-line maintenance therapy for advanced urothelial carcinoma (Hall C) - Oct 5, 2022 - Abstract #SITC2022SITC_984; P2, P3 After 4-10 weeks from end of chemotherapy, 252 patients will be randomized 1:2:2:2 to avelumab 800 mg every 2 weeks as monotherapy (control) or combined with sacituzumab govitecan (anti-Trop2/topoisomerase inhibitor conjugate) 10 mg/kg on days 1 and 8 of 21-day cycles, M6223 (anti-TIGIT) 1600 mg every 2 weeks, or NKTR-255 (IL-15 agonist) 3 μg/kg every 4 weeks...Secondary endpoints include OS, objective response and duration of response based on investigator assessment (RECIST 1.1), and pharmacokinetics. The trial opened in June 2022 with sites planned to recruit in the US, Europe, Asia, and Australia.
- |||||||||| NKTR-255 / Nektar Therap
Enrollment status, Trial completion date, Trial primary completion date: NKTR-255 in Relapsed/Refractory Multiple Myeloma & Non-Hodgkin Lymphoma (clinicaltrials.gov) - Sep 14, 2022 P1, N=118, Enrolling by invitation, The trial opened in June 2022 with sites planned to recruit in the US, Europe, Asia, and Australia. Recruiting --> Enrolling by invitation | Trial completion date: Jan 2023 --> Oct 2023 | Trial primary completion date: Jun 2022 --> Mar 2023
- |||||||||| NKTR-255 / Nektar Therap
Targeting Ewing sarcoma (ES), Osteosarcoma (OS) and Neuroblastoma (NB) with Anti MCAM Chimeric Antigen Receptor (CAR) Modified Natural Killer (NK) Cells () - Apr 20, 2022 - Abstract #ASPHO2022ASPHO_611; NKTR-255 is an investigational IL-15Rα-dependent, polymer-conjugated, recombinant human IL- 15 agonist that retains the full spectrum of IL-15 biology, including expansion of NK cells (4,5)...Miyazaki, JITC, 2021 5. Robinson, JCI, 2021
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