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Article ; Online: Strategies to Implement a Competency Assessment Verification Program.

O'Neal, Julie / Fencl, Jennifer L

2021 Volume 113, Issue 5, Page(s) 455–463

Abstract: Professional role competence is an essential element of nursing practice and an integral component of providing safe perioperative patient care. In the health care setting, verifying professional role competence and managing the associated documentation ... ...

Abstract	Professional role competence is an essential element of nursing practice and an integral component of providing safe perioperative patient care. In the health care setting, verifying professional role competence and managing the associated documentation can be complex. Educators can use a variety of modalities (eg, flipped classrooms, gaming, podcasts) to present information in a manner that supports adult learning principles. When developing a competency assessment verification program, perioperative leaders should use a structured model to provide consistency; they also should partner with staff members and other key stakeholders (eg, surgeons, risk management personnel) to identify and prioritize ongoing competencies. The leaders and educators should identify competency verification methods, and leaders should designate qualified observers if needed. Documentation of competency activities should be stored in an easily accessible location. Implementing a standardized competency assessment verification program is a best practice that should result in improved patient outcomes.
MeSH term(s)	Clinical Competence ; Humans ; Professional Competence ; Program Evaluation
Language	English
Publishing date	2021-04-30
Publishing country	United States
Document type	Journal Article
ZDB-ID	603972-8
ISSN	1878-0369 ; 0001-2092
ISSN (online)	1878-0369
ISSN	0001-2092
DOI	10.1002/aorn.13370
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Article: The North Carolina-Republic of Moldova Nursing Collaborative.

Lekan, Deborah A / O'Neal, Julie V

Tar heel nurse

2018 Volume 78, Issue 4, Page(s) 12

MeSH term(s)	Humans ; International Cooperation ; International Educational Exchange ; Moldova ; North Carolina ; Nursing
Language	English
Publishing date	2018-11-07
Publishing country	United States
Document type	Journal Article
ISSN	0039-9620
ISSN	0039-9620
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Article ; Online: An "off-the-shelf" CD2 universal CAR-T therapy for T-cell malignancies.

Xiang, Jingyu / Devenport, Jessica M / Carter, Alun J / Staser, Karl W / Kim, Miriam Y / O' Neal, Julie / Ritchey, Julie K / Rettig, Michael P / Gao, Feng / Rettig, Garrett / Turk, Rolf / Lee, Byung Ha / Cooper, Matthew L / DiPersio, John F

Leukemia

2023 Volume 37, Issue 12, Page(s) 2448–2456

Abstract: T-cell malignancies are associated with frequent relapse and high morbidity, which is partly due to the lack of effective or targeted treatment options. To broaden the use of CAR-T cells in pan T-cell malignancies, we developed an allogeneic "universal" ... ...

Abstract	T-cell malignancies are associated with frequent relapse and high morbidity, which is partly due to the lack of effective or targeted treatment options. To broaden the use of CAR-T cells in pan T-cell malignancies, we developed an allogeneic "universal" CD2-targeting CAR-T cell (UCART2), in which the CD2 antigen is deleted to prevent fratricide, and the T-cell receptor is removed to prevent GvHD. UCART2 demonstrated efficacy against T-ALL and CTCL and prolonged the survival of tumor-engrafted NSG mice in vivo. To evaluate the impact of CD2 on CAR-T function, we generated CD19 CAR-T cells (UCART19) with or without CD2 deletion, single-cell secretome analysis revealed that CD2 deletion in UCART19 reduced frequencies of the effector cytokines (Granzyme-B and IFN-γ). We also observed that UCART19ΔCD2 had reduced anti-tumor efficacy compared to UCART19 in a CD19+NALM6 xenograft model. Of note is that the reduced efficacy resulting from CD2 deletion was reversed when combined with rhIL-7-hyFc, a long-acting recombinant human interleukin-7. Treatment with rhIL-7-hyFc prolonged UCART2 persistence and increased survival in both the tumor re-challenge model and primary patient T-ALL model in vivo. Together, these data suggest that allogeneic fratricide-resistant UCART2, in combination with rhIL-7-hyFc, could be a suitable approach for treating T-cell malignancies.
MeSH term(s)	Humans ; Mice ; Animals ; T-Lymphocytes ; Receptors, Chimeric Antigen/genetics ; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma ; Neoplasm Recurrence, Local ; Immunotherapy, Adoptive/methods ; Receptors, Antigen, T-Cell ; Antigens, CD19
Chemical Substances	Receptors, Chimeric Antigen ; Receptors, Antigen, T-Cell ; Antigens, CD19
Language	English
Publishing date	2023-10-05
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	807030-1
ISSN	1476-5551 ; 0887-6924
ISSN (online)	1476-5551
ISSN	0887-6924
DOI	10.1038/s41375-023-02039-z
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Article ; Online: Liposomal phytohemagglutinin: In vivo T-cell activator as a novel pan-cancer immunotherapy.

Alhallak, Kinan / Sun, Jennifer / Muz, Barbara / Jeske, Amanda / O'Neal, Julie / Ritchey, Julie K / Achilefu, Samuel / DiPersio, John F / Azab, Abdel Kareem

Journal of cellular and molecular medicine

2022 Volume 26, Issue 3, Page(s) 940–944

Abstract: Immunotherapy is an attractive approach for treating cancer. T-cell engagers (TCEs) are a type of immunotherapy that are highly efficacious; however, they are challenged by weak T-cell activation and short persistence. Therefore, alternative solutions to ...

Abstract	Immunotherapy is an attractive approach for treating cancer. T-cell engagers (TCEs) are a type of immunotherapy that are highly efficacious; however, they are challenged by weak T-cell activation and short persistence. Therefore, alternative solutions to induce greater activation and persistence of T cells during TCE immunotherapy is needed. Methods to activate T cells include the use of lectins, such as phytohemagglutinin (PHA). PHA has not been used to activate T cells in vivo, for immunotherapy, due to its biological instability and toxicity. An approach to overcome the limitations of PHA while also preserving its function is needed. In this study, we report a liposomal PHA which increased PHA stability, reduced toxicity and performed as an immunotherapeutic that is able to activate T cells for the use in future cancer immunotherapies to circumvent current obstacles in immunosuppression and T-cell exhaustion.
MeSH term(s)	Humans ; Immunotherapy/methods ; Lymphocyte Activation ; Neoplasms/therapy ; Phytohemagglutinins/pharmacology ; T-Lymphocytes
Chemical Substances	Phytohemagglutinins
Language	English
Publishing date	2022-01-11
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	2074559-X
ISSN	1582-4934 ; 1582-4934 ; 1582-1838
ISSN (online)	1582-4934
ISSN	1582-4934 ; 1582-1838
DOI	10.1111/jcmm.16885
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Article ; Online: Development of [

Ghai, Anchal / Zheleznyak, Alexander / Mixdorf, Matt / O'Neal, Julie / Ritchey, Julie / Rettig, Michael / DiPersio, John / Shokeen, Monica / Achilefu, Samuel

European journal of nuclear medicine and molecular imaging

2020 Volume 48, Issue 5, Page(s) 1302–1311

Abstract: Purpose: Multiple myeloma (MM) is a bone marrow malignancy that remains mostly incurable. Elotuzumab is an FDA-approved therapeutic monoclonal antibody targeted to the cell surface glycoprotein CS1, which is overexpressed in MM cells. Identifying ... ...

Abstract	Purpose: Multiple myeloma (MM) is a bone marrow malignancy that remains mostly incurable. Elotuzumab is an FDA-approved therapeutic monoclonal antibody targeted to the cell surface glycoprotein CS1, which is overexpressed in MM cells. Identifying patients who will respond to CS1-targeted treatments such as elotuzumab requires the development of a companion diagnostic to assess the presence of CS1. Here, we evaluated [ Methods: Conjugation of desferrioxamine-p-benzyl-isothiocyanate (DFO-Bz-NCS) to elotuzumab enabled zirconium-89 radiolabeling. MM.1S-CG cells were intravenously injected in NOD SCID gamma (NSG) mice. Small animal PET imaging with [ Results: [ Conclusion: These data demonstrate the feasibility of [
MeSH term(s)	Animals ; Antibodies, Monoclonal, Humanized ; Cell Line, Tumor ; Humans ; Mice ; Mice, SCID ; Multiple Myeloma/diagnostic imaging ; Positron-Emission Tomography ; Tissue Distribution ; Zirconium
Chemical Substances	Antibodies, Monoclonal, Humanized ; elotuzumab (1351PE5UGS) ; Zirconium (C6V6S92N3C)
Language	English
Publishing date	2020-11-11
Publishing country	Germany
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, U.S. Gov't, Non-P.H.S.
ZDB-ID	8236-3
ISSN	1619-7089 ; 0340-6997 ; 1619-7070
ISSN (online)	1619-7089
ISSN	0340-6997 ; 1619-7070
DOI	10.1007/s00259-020-05097-y
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Zs.A 1227: Show issues

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Article ; Online: Anti-myeloma efficacy of CAR-iNKT is enhanced with a long-acting IL-7, rhIL-7-hyFc.

O'Neal, Julie / Cooper, Matthew L / Ritchey, Julie K / Gladney, Susan / Niswonger, Jessica / González, L Sofía / Street, Emily / Haas, Gabriel J / Carter, Alun / Amayta, Parmeshwar N / Gao, Feng / Lee, Byung Ha / Choi, Donghoon / Berrien-Elliott, Melissa / Zhou, Alice / Fehniger, Todd A / Rettig, Mike P / DiPersio, John F

Blood advances

2023 Volume 7, Issue 20, Page(s) 6009–6022

Abstract: Multiple myeloma (MM), a malignancy of mature plasma cells, remains incurable. B-cell maturation antigen (BCMA) is the lead protein target for chimeric antigen receptor (CAR) therapy because of its high expression in most MM, with limited expression in ... ...

Abstract	Multiple myeloma (MM), a malignancy of mature plasma cells, remains incurable. B-cell maturation antigen (BCMA) is the lead protein target for chimeric antigen receptor (CAR) therapy because of its high expression in most MM, with limited expression in other cell types, resulting in favorable on-target, off tumor toxicity. The response rate to autologous BCMA CAR-T therapy is high; however, it is not curative and is associated with risks of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome. Outcomes in patients treated with BCMA CAR-T cells (CAR-Ts) may improve with allogeneic CAR T-cell therapy, which offer higher cell fitness and reduced time to treatment. However, to prevent the risk of graft-versus-host disease (GVHD), allogenic BCMA CAR-Ts require genetic deletion of the T-cell receptor (TCR), which has potential for unexpected functional or phenotype changes. Invariant natural killer T cells (iNKTs) have an invariant TCR that does not cause GVHD and, as a result, can be used in an allogeneic setting without the need for TCR gene editing. We demonstrate significant anti-myeloma activity of BCMA CAR-iNKTs in a xenograft mouse model of myeloma. We found that a long-acting interleukin-7 (IL-7), rhIL-7-hyFc, significantly prolonged survival and reduced tumor burden in BCMA CAR-iNKT-treated mice in both primary and re-challenge settings. Furthermore, in CRS in vitro assays, CAR-iNKTs induced less IL-6 than CAR-Ts, suggesting a reduced likelihood of CAR-iNKT therapy to induce CRS in patients. These data suggest that BCMA CAR-iNKTs are potentially a safer, effective alternative to BCMA CAR-Ts and that BCMA CAR-iNKT efficacy is further potentiated with rhIL-7-hyFc.
MeSH term(s)	Humans ; Animals ; Mice ; Multiple Myeloma/genetics ; Interleukin-7 ; Receptors, Chimeric Antigen/metabolism ; B-Cell Maturation Antigen ; Receptors, Antigen, T-Cell/genetics ; Graft vs Host Disease/etiology ; Graft vs Host Disease/prevention & control
Chemical Substances	efineptakin alfa (3K3WC6MT6P) ; Interleukin-7 ; cell-associated neurotoxicity ; Receptors, Chimeric Antigen ; B-Cell Maturation Antigen ; Receptors, Antigen, T-Cell
Language	English
Publishing date	2023-07-01
Publishing country	United States
Document type	Journal Article
ZDB-ID	2915908-8
ISSN	2473-9537 ; 2473-9529
ISSN (online)	2473-9537
ISSN	2473-9529
DOI	10.1182/bloodadvances.2023010032
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Article ; Online: Ablation of VLA4 in multiple myeloma cells redirects tumor spread and prolongs survival.

Hathi, Deep / Chanswangphuwana, Chantiya / Cho, Nicholas / Fontana, Francesca / Maji, Dolonchampa / Ritchey, Julie / O'Neal, Julie / Ghai, Anchal / Duncan, Kathleen / Akers, Walter J / Fiala, Mark / Vij, Ravi / DiPersio, John F / Rettig, Michael / Shokeen, Monica

Scientific reports

2022 Volume 12, Issue 1, Page(s) 30

Abstract: Multiple myeloma (MM) is a cancer of bone marrow (BM) plasma cells, which is increasingly treatable but still incurable. In 90% of MM patients, severe osteolysis results from pathological interactions between MM cells and the bone microenvironment. ... ...

Abstract	Multiple myeloma (MM) is a cancer of bone marrow (BM) plasma cells, which is increasingly treatable but still incurable. In 90% of MM patients, severe osteolysis results from pathological interactions between MM cells and the bone microenvironment. Delineating specific molecules and pathways for their role in cancer supportive interactions in the BM is vital for developing new therapies. Very Late Antigen 4 (VLA4, integrin α
MeSH term(s)	Animals ; Bone Marrow/metabolism ; Fluorescent Dyes/chemistry ; Fluorescent Dyes/metabolism ; Green Fluorescent Proteins/chemistry ; Green Fluorescent Proteins/genetics ; Green Fluorescent Proteins/metabolism ; Humans ; Integrin alpha4beta1/chemistry ; Integrin alpha4beta1/genetics ; Integrin alpha4beta1/metabolism ; Mice ; Mice, Inbred C57BL ; Mice, Knockout ; Microscopy, Confocal ; Multiple Myeloma/chemistry ; Multiple Myeloma/genetics ; Multiple Myeloma/metabolism
Chemical Substances	Fluorescent Dyes ; Integrin alpha4beta1 ; Green Fluorescent Proteins (147336-22-9)
Language	English
Publishing date	2022-01-07
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-021-03748-0
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Article ; Online: A long-acting interleukin-7, rhIL-7-hyFc, enhances CAR T cell expansion, persistence, and anti-tumor activity.

Kim, Miriam Y / Jayasinghe, Reyka / Devenport, Jessica M / Ritchey, Julie K / Rettig, Michael P / O'Neal, Julie / Staser, Karl W / Kennerly, Krista M / Carter, Alun J / Gao, Feng / Lee, Byung Ha / Cooper, Matthew L / DiPersio, John F

Nature communications

2022 Volume 13, Issue 1, Page(s) 3296

Abstract: Chimeric antigen receptor (CAR) T cell therapy is routinely used to treat patients with refractory hematologic malignancies. However, a significant proportion of patients experience suboptimal CAR T cell cytotoxicity and persistence that can permit tumor ...

Abstract	Chimeric antigen receptor (CAR) T cell therapy is routinely used to treat patients with refractory hematologic malignancies. However, a significant proportion of patients experience suboptimal CAR T cell cytotoxicity and persistence that can permit tumor cell escape and disease relapse. Here we show that a prototype pro-lymphoid growth factor is able to enhance CAR T cell efficacy. We demonstrate that a long-acting form of recombinant human interleukin-7 (IL-7) fused with hybrid Fc (rhIL-7-hyFc) promotes proliferation, persistence and cytotoxicity of human CAR T cells in xenogeneic mouse models, and murine CAR T cells in syngeneic mouse models, resulting in long-term tumor-free survival. Thus, rhIL-7-hyFc represents a tunable clinic-ready adjuvant for improving suboptimal CAR T cell activity.
MeSH term(s)	Animals ; Cell Proliferation ; Humans ; Interleukin-7/pharmacology ; Mice ; Neoplasms ; Receptors, Chimeric Antigen ; Recombinant Fusion Proteins ; T-Lymphocytes
Chemical Substances	Interleukin-7 ; Receptors, Chimeric Antigen ; Recombinant Fusion Proteins ; efineptakin alfa (3K3WC6MT6P)
Language	English
Publishing date	2022-06-13
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, N.I.H., Extramural
ZDB-ID	2553671-0
ISSN	2041-1723 ; 2041-1723
ISSN (online)	2041-1723
ISSN	2041-1723
DOI	10.1038/s41467-022-30860-0
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Article ; Online: CS1 CAR-T targeting the distal domain of CS1 (SLAMF7) shows efficacy in high tumor burden myeloma model despite fratricide of CD8+CS1 expressing CAR-T cells.

O'Neal, Julie / Ritchey, Julie K / Cooper, Matthew L / Niswonger, Jessica / Sofía González, L / Street, Emily / Rettig, Michael P / Gladney, Susan W / Gehrs, Leah / Abboud, Ramzi / Prior, Julie L / Haas, Gabriel J / Jayasinghe, Reyka G / Ding, Li / Ghobadi, Armin / Vij, Ravi / DiPersio, John F

Leukemia

2022 Volume 36, Issue 6, Page(s) 1625–1634

Abstract: Despite improvement in treatment options for myeloma patients, including targeted immunotherapies, multiple myeloma remains a mostly incurable malignancy. High CS1 (SLAMF7) expression on myeloma cells and limited expression on normal cells makes it a ... ...

Abstract	Despite improvement in treatment options for myeloma patients, including targeted immunotherapies, multiple myeloma remains a mostly incurable malignancy. High CS1 (SLAMF7) expression on myeloma cells and limited expression on normal cells makes it a promising target for CAR-T therapy. The CS1 protein has two extracellular domains - the distal Variable (V) domain and the proximal Constant 2 (C2) domain. We generated and tested CS1-CAR-T targeting the V domain of CS1 (Luc90-CS1-CAR-T) and demonstrated anti-myeloma killing in vitro and in vivo using two mouse models. Since fratricide of CD8 + cells occurred during production, we generated fratricide resistant CS1 deficient Luc90- CS1- CAR-T (ΔCS1-Luc90- CS1- CAR-T). This led to protection of CD8 + cells in the CAR-T cultures, but had no impact on efficacy. Our data demonstrate targeting the distal V domain of CS1 could be an effective CAR-T treatment for myeloma patients and deletion of CS1 in clinical production did not provide an added benefit using in vivo immunodeficient NSG preclinical models.
MeSH term(s)	Animals ; CD8-Positive T-Lymphocytes/pathology ; Humans ; Immunotherapy, Adoptive ; Mice ; Multiple Myeloma/pathology ; Receptors, Chimeric Antigen/metabolism ; Signaling Lymphocytic Activation Molecule Family/metabolism ; T-Lymphocytes/metabolism ; Tumor Burden ; Xenograft Model Antitumor Assays
Chemical Substances	Receptors, Chimeric Antigen ; SLAMF7 protein, human ; Signaling Lymphocytic Activation Molecule Family
Language	English
Publishing date	2022-04-14
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, N.I.H., Extramural
ZDB-ID	807030-1
ISSN	1476-5551 ; 0887-6924
ISSN (online)	1476-5551
ISSN	0887-6924
DOI	10.1038/s41375-022-01559-4
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Article ; Online: Nanoparticle T-cell engagers as a modular platform for cancer immunotherapy.

Alhallak, Kinan / Sun, Jennifer / Wasden, Katherine / Guenthner, Nicole / O'Neal, Julie / Muz, Barbara / King, Justin / Kohnen, Daniel / Vij, Ravi / Achilefu, Samuel / DiPersio, John F / Azab, Abdel Kareem

Leukemia

2021 Volume 35, Issue 8, Page(s) 2346–2357

Abstract: T-cell-based immunotherapy, such as CAR-T cells and bispecific T-cell engagers (BiTEs), has shown promising clinical outcomes in many cancers; however, these therapies have significant limitations, such as poor pharmacokinetics and the ability to target ... ...

Abstract	T-cell-based immunotherapy, such as CAR-T cells and bispecific T-cell engagers (BiTEs), has shown promising clinical outcomes in many cancers; however, these therapies have significant limitations, such as poor pharmacokinetics and the ability to target only one antigen on the cancer cells. In multiclonal diseases, these therapies confer the development of antigen-less clones, causing tumor escape and relapse. In this study, we developed nanoparticle-based bispecific T-cell engagers (nanoBiTEs), which are liposomes decorated with anti-CD3 monoclonal antibodies (mAbs) targeting T cells, and mAbs targeting the cancer antigen. We also developed a nanoparticle that targets multiple cancer antigens by conjugating multiple mAbs against multiple cancer antigens for T-cell engagement (nanoMuTEs). NanoBiTEs and nanoMuTEs have a long half-life of about 60 h, which enables once-a-week administration instead of continuous infusion, while maintaining efficacy in vitro and in vivo. NanoMuTEs targeting multiple cancer antigens showed greater efficacy in myeloma cells in vitro and in vivo, compared to nanoBiTEs targeting only one cancer antigen. Unlike nanoBiTEs, treatment with nanoMuTEs did not cause downregulation (or loss) of a single antigen, and prevented the development of antigen-less tumor escape. Our nanoparticle-based immuno-engaging technology provides a solution for the major limitations of current immunotherapy technologies.
MeSH term(s)	Animals ; Antibodies, Monoclonal/administration & dosage ; Antibodies, Monoclonal/immunology ; Antigens, Neoplasm/immunology ; Apoptosis ; Cell Proliferation ; Female ; Humans ; Immunotherapy/methods ; Mice ; Mice, Inbred NOD ; Mice, SCID ; Multiple Myeloma/immunology ; Multiple Myeloma/metabolism ; Multiple Myeloma/pathology ; Multiple Myeloma/therapy ; Nanoparticles/administration & dosage ; Nanoparticles/chemistry ; T-Lymphocytes/immunology ; Tumor Cells, Cultured ; Xenograft Model Antitumor Assays
Chemical Substances	Antibodies, Monoclonal ; Antigens, Neoplasm
Language	English
Publishing date	2021-01-21
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	807030-1
ISSN	1476-5551 ; 0887-6924
ISSN (online)	1476-5551
ISSN	0887-6924
DOI	10.1038/s41375-021-01127-2
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