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- || STK-009/SYNCAR-001 / Synthekine
Enrollment open, CAR T-Cell Therapy: Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects With Severe, Refractory Systemic Lupus Erythematosus (clinicaltrials.gov) - Sep 20, 2024
P1, N=42, Recruiting, Sponsor: Synthekine
Not yet recruiting --> Recruiting
- || STK-009/SYNCAR-001 / Synthekine
New P1 trial, CAR T-Cell Therapy: Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects With Severe, Refractory Systemic Lupus Erythematosus (clinicaltrials.gov) - Aug 9, 2024
P1, N=42, Not yet recruiting, Sponsor: Synthekine
- STK-009/SYNCAR-001 / Synthekine
Orthogonal IL-2/IL-2R? signaling selectively enhances and sustains a synthetic effector state via a novel mechanism and outperforms constitutive armoring approaches (Section 40) - Mar 5, 2024 - Abstract #AACR2024AACR_7710;
P1
This analysis also identified a novel mechanism by which STK-009/oR? signaling induces a superior synthetic effector state via transcriptional repression of the stress response/proteosome.These findings support the advantages of an orthogonal platform that selectively drives and sustains potent T cell effector function without safety concerns associated with constitutively expressed armored approaches.
- | STK-009/SYNCAR-001 / Synthekine
Trial primary completion date, CAR T-Cell Therapy: Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects With CD19+ Hematologic Malignancies (clinicaltrials.gov) - Feb 20, 2024
P1, N=36, Recruiting, Sponsor: Synthekine
signaling induces a superior synthetic effector state via transcriptional repression of the stress response/proteosome.These findings support the advantages of an orthogonal platform that selectively drives and sustains potent T cell effector function without safety concerns associated with constitutively expressed armored approaches. Trial primary completion date: Jun 2024 --> Jun 2026
- | STK-009/SYNCAR-001 / Synthekine
Trial completion date, Trial primary completion date, CAR T-Cell Therapy: Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects With CD19+ Hematologic Malignancies (clinicaltrials.gov) - Dec 31, 2023
P1, N=36, Recruiting, Sponsor: Synthekine
- || STK-009/SYNCAR-001 / Synthekine
Trial initiation date, CAR T-Cell Therapy: Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects With CD19+ Hematologic Malignancies (clinicaltrials.gov) - Nov 21, 2023
P1, N=36, Recruiting, Sponsor: Synthekine
Trial primary completion date: Jun 2024 --> Jun 2026 Initiation date: Feb 2023 --> Jun 2022
- STK-009/SYNCAR-001 / Synthekine
Engineered human IL-2/IL-2R (Exhibit Hall B) - Sep 27, 2023 - Abstract #SITC2023SITC_596;
P1
Importantly, STK-009 induced the expression of cytotoxic machinery, pro-survival, and proliferative genes in tumor-infiltrating SYNCAR-002 (figure 3). Conclusions These findings validate that the orthogonal IL-2 platform has the potential to improve the efficacy and durability of CAR T therapy for solid tumor targets such as GPC3 by selectively expanding CAR-T cells in vivo and activating CAR-T cells in a hostile tumor microenvironment.
- STK-009/SYNCAR-001 / Synthekine
A Phase 1 study to evaluate the safety and tolerability of a combination autologous CD19 CAR T cell therapy (SYNCAR-001) and orthogonal IL-2 (STK-009) in subjects with relapsed or refractory CD19 expressing hematologic malignancies (NCT05665062) (Section 46; Poster Board #13) - Mar 14, 2023 - Abstract #AACR2023AACR_4823;
P1
Secondary endpoints include assessments of response, pharmacokinetics, and immunogenicity. Exploratory endpoints include assessment of immune cell populations, and relevant gene/protein expression, as well as persistence, phenotype, and functionality of SYNCAR-001 in the peripheral blood and/or bone marrow in response to STK-009.
- || STK-009/SYNCAR-001 / Synthekine
New P1 trial, CAR T-Cell Therapy: Autologous CD19 CAR-T Cell Therapy (SYNCAR-001) + Orthogonal IL-2 (STK-009) in Subjects With CD19+ Hematologic Malignancies (clinicaltrials.gov) - Dec 27, 2022
P1, N=36, Recruiting, Sponsor: Synthekine
- STK-009/SYNCAR-001 / Synthekine
Engineered human IL-2/IL-2Rb orthogonal pairs selectively enhance anti-GPC3 CAR T cells to drive complete responses in solid epithelial tumor models (Section 35) - Mar 9, 2022 - Abstract #AACR2022AACR_4766;
STK-009 treatment resulted in significant expansion of SYNCAR-002 and drove infiltration of SYNCAR-002 into tumors. STK-009 treatment also induced intratumoral granzyme B+ and IFN-γ+ production by SYNCAR-002 indicating activation of effector T cell function.These findings validate that the orthogonal IL-2 platform has the potential to improve the efficacy and durability of CAR T therapy for solid tumor targets such as GPC3 by selectively expanding CAR-T cells in vivo, driving CAR-T cells into the tumor, and activating CAR-T cells in the tumor microenvironment.
- STK-009/SYNCAR-001 / Synthekine
[VIRTUAL] OrthoCARs: Engineered human IL-2/IL-2Rb orthogonal pairs selectively enhance CAR T cell antitumor efficacy by driving T cell expansion and fitness () - Mar 11, 2021 - Abstract #AACR2021AACR_610;
Pharmacokinetic analysis of STK-009 shows stable exposure with minimal clearance, demonstrating the selectivity of STK-009.These findings validate an orthogonal platform that selectively drives potent T cell effector functions of engineered cells without the toxicities mediated by NK cells or non-tumor specific T cells associated with high dose IL-2 therapy. These results demonstrate the ability of this orthogonal platform to improve the efficacy and durability of CARs.