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Article ; Online: Regulatory T-cell therapy for autoimmune and autoinflammatory diseases: The next frontier.

Esensten, Jonathan H / Muller, Yannick D / Bluestone, Jeffrey A / Tang, Qizhi

The Journal of allergy and clinical immunology

2018 Volume 142, Issue 6, Page(s) 1710–1718

Abstract: Forkhead box P3-expressing regulatory T (Treg) cells are essential for self-tolerance, with an emerging role in tissue repair and regeneration. Their ability to traffic to tissue and perform complex therapeutic tasks in response to the tissue ... ...

Abstract	Forkhead box P3-expressing regulatory T (Treg) cells are essential for self-tolerance, with an emerging role in tissue repair and regeneration. Their ability to traffic to tissue and perform complex therapeutic tasks in response to the tissue microenvironment make them an attractive candidate for drug development. Early experiences of Treg cell therapy in patients with graft-versus-host disease, type 1 diabetes, and organ transplantation have shown that it is feasible, safe, and potentially efficacious in some settings. Many ongoing trials in patients with a wide variety of diseases will further enhance our knowledge about the optimal approaches for Treg cell manufacturing and dosing. We review the current preclinical rationale supporting Treg cell therapy in a variety of disease settings ranging from tissue transplantation, autoimmune diseases, and non-immune-mediated inflammatory settings. We point out challenges in development of Treg cell therapy and speculate how synthetic biology can be used to enhance the feasibility and efficacy of Treg cell therapy for autoimmune and autoinflammatory diseases.
MeSH term(s)	Animals ; Autoimmune Diseases/therapy ; Humans ; Immunotherapy, Adoptive ; Inflammation/therapy ; T-Lymphocytes, Regulatory/immunology ; T-Lymphocytes, Regulatory/transplantation
Language	English
Publishing date	2018-10-25
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	121011-7
ISSN	1097-6825 ; 1085-8725 ; 0091-6749
ISSN (online)	1097-6825 ; 1085-8725
ISSN	0091-6749
DOI	10.1016/j.jaci.2018.10.015
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Article ; Online: Engineering Therapeutic T Cells: From Synthetic Biology to Clinical Trials.

Esensten, Jonathan H / Bluestone, Jeffrey A / Lim, Wendell A

Annual review of pathology

2016 Volume 12, Page(s) 305–330

Abstract: Engineered T cells are currently in clinical trials to treat patients with cancer, solid organ transplants, and autoimmune diseases. However, the field is still in its infancy. The design, and manufacturing, of T cell therapies is not standardized and is ...

Abstract	Engineered T cells are currently in clinical trials to treat patients with cancer, solid organ transplants, and autoimmune diseases. However, the field is still in its infancy. The design, and manufacturing, of T cell therapies is not standardized and is performed mostly in academic settings by competing groups. Reliable methods to define dose and pharmacokinetics of T cell therapies need to be developed. As of mid-2016, there are no US Food and Drug Administration (FDA)-approved T cell therapeutics on the market, and FDA regulations are only slowly adapting to the new technologies. Further development of engineered T cell therapies requires advances in immunology, synthetic biology, manufacturing processes, and government regulation. In this review, we outline some of these challenges and discuss the contributions that pathologists can make to this emerging field.
MeSH term(s)	Animals ; Autoimmune Diseases/immunology ; Autoimmune Diseases/therapy ; Cell- and Tissue-Based Therapy ; Clinical Trials as Topic ; Humans ; Neoplasms/immunology ; Neoplasms/therapy ; Synthetic Biology ; T-Lymphocytes/immunology
Language	English
Publishing date	2016-12-05
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2227429-7
ISSN	1553-4014 ; 1553-4006
ISSN (online)	1553-4014
ISSN	1553-4006
DOI	10.1146/annurev-pathol-052016-100304
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Article ; Online: Processing laboratory considerations for multi-center cellular therapy clinical trials: a report from the Consortium for Pediatric Cellular Immunotherapy.

Lindgren, Catherine / Leinbach, Ashley / Annis, Julie / Tanna, Jay / Zhang, Nan / Esensten, Jonathan H / Hanley, Patrick J

Cytotherapy

2020 Volume 23, Issue 2, Page(s) 157–164

Abstract: Cellular therapies first emerged as specialized therapies only available at a few "boutique" centers worldwide. To ensure broad access to these investigational therapies-regardless of geography, demographics and other factors-more and more academic ... ...

Abstract	``Cellular therapies first emerged as specialized therapies only available at a few "boutique" centers worldwide. To ensure broad access to these investigational therapies-regardless of geography, demographics and other factors-more and more academic clinical trials are becoming multi-center. Such trials are typically performed with a centralized manufacturing facility receiving the starting material and shipping the final product, either fresh or cryopreserved, to the patient's institution for infusion. As these academic multi-center trials increase in number, it is critical to have procedures and training programs in place to allow these sites that are remote from the production facility to successfully participate in these trials and satisfy regulatory compliance and patient safety best practices. Based on the collective experience of the Consortium for Pediatric Cellular Immunotherapy, the authors summarize the challenges encountered by institutions in shipping and receiving the starting material and final product as well as preparing the final product for infusion. The authors also discuss best practices implemented by each of the consortia institutions to overcome these challenges.
MeSH term(s)	Cell- and Tissue-Based Therapy ; Child ; Clinical Trials as Topic ; Cryopreservation ; Humans ; Immunotherapy ; Laboratories ; Manufacturing and Industrial Facilities
Language	English
Publishing date	2020-11-12
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2039821-9
ISSN	1477-2566 ; 1465-3249
ISSN (online)	1477-2566
ISSN	1465-3249
DOI	10.1016/j.jcyt.2020.09.013
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Article ; Online: Development of a robotic cluster for automated and scalable cell therapy manufacturing.

Melocchi, Alice / Schmittlein, Brigitte / Jones, Alexis L / Ainane, Yasmine / Rizvi, Ali / Chan, Darius / Dickey, Elaine / Pool, Kelsey / Harsono, Kenny / Szymkiewicz, Dorothy / Scarfogliero, Umberto / Bhatia, Varun / Sivanantham, Amlesh / Kreciglowa, Nadia / Hunter, Allison / Gomez, Miguel / Tanner, Adrian / Uboldi, Marco / Batish, Arpit /

Balcerek, Joanna / Kutova-Stoilova, Mariella / Paruthiyil, Sreenivasan / Acevedo, Luis A / Stadnitskiy, Rachel / Carmichael, Sabrina / Aulbach, Holger / Hewitt, Matthew / Jeu, Xavier De Mollerat Du / Robilant, Benedetta di / Parietti, Federico / Esensten, Jonathan H

Cytotherapy

2024

Abstract: Background aims: The production of commercial autologous cell therapies such as chimeric antigen receptor T cells requires complex manual manufacturing processes. Skilled labor costs and challenges in manufacturing scale-out have contributed to high ... ...

Abstract	Background aims: The production of commercial autologous cell therapies such as chimeric antigen receptor T cells requires complex manual manufacturing processes. Skilled labor costs and challenges in manufacturing scale-out have contributed to high prices for these products. Methods: We present a robotic system that uses industry-standard cell therapy manufacturing equipment to automate the steps involved in cell therapy manufacturing. The robotic cluster consists of a robotic arm and customized modules, allowing the robot to manipulate a variety of standard cell therapy instruments and materials such as incubators, bioreactors, and reagent bags. This system enables existing manual manufacturing processes to be rapidly adapted to robotic manufacturing, without having to adopt a completely new technology platform. Proof-of-concept for the robotic cluster's expansion module was demonstrated by expanding human CD8+ T cells. Results: The robotic cultures showed comparable cell yields, viability, and identity to those manually performed. In addition, the robotic system was able to maintain culture sterility. Conclusions: Such modular robotic solutions may support scale-up and scale-out of cell therapies that are developed using classical manual methods in academic laboratories and biotechnology companies. This approach offers a pathway for overcoming manufacturing challenges associated with manual processes, ultimately contributing to the broader accessibility and affordability for personalized immunotherapies.
Language	English
Publishing date	2024-03-15
Publishing country	England
Document type	Journal Article
ZDB-ID	2039821-9
ISSN	1477-2566 ; 1465-3249
ISSN (online)	1477-2566
ISSN	1465-3249
DOI	10.1016/j.jcyt.2024.03.010
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Article ; Online: Hospital-Based Donor Recruitment and Predonation Serologic Testing for COVID-19 Convalescent Plasma.

Balcerek, Joanna / Trejo, Evelin / Levine, Kendall / Couey, Paul / Kornberg, Zoe V / Rogine, Camille / Young, Charlotte / Li, P Jonathan / Shy, Brian R / Taylor, Jordan E / Bakhtary, Sara / Friedlander, Terence / Lynch, Kara L / Bern, Caryn / Esensten, Jonathan H

American journal of clinical pathology

2021 Volume 155, Issue 4, Page(s) 515–521

Abstract: Objectives: Serologic testing for antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in potential donors of coronavirus disease 2019 (COVID-19) convalescent plasma (CCP) may not be performed until after blood donation. A hospital- ...

Abstract	Objectives: Serologic testing for antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in potential donors of coronavirus disease 2019 (COVID-19) convalescent plasma (CCP) may not be performed until after blood donation. A hospital-based recruitment program for CCP may be an efficient way to identify potential donors prospectively. Methods: Patients who recovered from known or suspected COVID-19 were identified and recruited through medical record searches and public appeals in March and April 2020. Participants were screened with a modified donor history questionnaire and, if eligible, were asked for consent and tested for SARS-CoV-2 antibodies (IgG and IgM). Participants positive for SARS-CoV-2 IgG were referred for CCP collection. Results: Of 179 patients screened, 128 completed serologic testing and 89 were referred for CCP donation. IgG antibodies to SARS-CoV-2 were detected in 23 of 51 participants with suspected COVID-19 and 66 of 77 participants with self-reported COVID-19 confirmed by polymerase chain reaction (PCR). The anti-SARS-CoV-2 IgG level met the US Food and Drug Administration criteria for "high-titer" CCP in 39% of participants confirmed by PCR, as measured by the Ortho VITROS IgG assay. A wide range of SARS-CoV-2 IgG levels were observed. Conclusions: A hospital-based CCP donor recruitment program can prospectively identify potential CCP donors. Variability in SARS-CoV-2 IgG levels has implications for the selection of CCP units for transfusion.
MeSH term(s)	Adolescent ; Adult ; Aged ; Aged, 80 and over ; COVID-19/therapy ; COVID-19 Serological Testing/methods ; Female ; Hospitals ; Humans ; Immunization, Passive ; Linear Models ; Male ; Middle Aged ; San Francisco ; Tissue Donors ; Tissue and Organ Procurement/methods ; Tissue and Organ Procurement/organization & administration ; Young Adult
Language	English
Publishing date	2021-01-05
Publishing country	England
Document type	Journal Article
ZDB-ID	2944-0
ISSN	1943-7722 ; 0002-9173
ISSN (online)	1943-7722
ISSN	0002-9173
DOI	10.1093/ajcp/aqaa268
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Article ; Online: Selective decrease of donor-reactive T

Science translational medicine

2022 Volume 14, Issue 669, Page(s) eabo2628

Abstract: Promoting immune tolerance to transplanted organs can minimize the amount of immunosuppressive drugs that patients need to take, reducing lifetime risks of mortality and morbidity. Regulatory T cells ( ... ...

Abstract	Promoting immune tolerance to transplanted organs can minimize the amount of immunosuppressive drugs that patients need to take, reducing lifetime risks of mortality and morbidity. Regulatory T cells (T
MeSH term(s)	Humans ; Transplantation Tolerance ; Liver Transplantation/methods ; T-Lymphocytes, Regulatory ; Graft Rejection/prevention & control ; Living Donors
Language	English
Publishing date	2022-11-02
Publishing country	United States
Document type	Clinical Trial, Phase II ; Clinical Trial, Phase I ; Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2518854-9
ISSN	1946-6242 ; 1946-6234
ISSN (online)	1946-6242
ISSN	1946-6234
DOI	10.1126/scitranslmed.abo2628
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Article: Characteristics of High-Titer Convalescent Plasma and Antibody Dynamics After Administration in Patients With Severe Coronavirus Disease 2019.

Bainbridge, Emma D / Hsue, Priscilla Y / Esensten, Jonathan H / Lynch, Kara L / Hendrickson, Carolyn M / Doernberg, Sarah B / Fung, Monica / Chin-Hong, Peter / Di Germanio, Clara / Norris, Philip J / Simmons, Graham / Glidden, David V / Luetkemeyer, Anne F

Open forum infectious diseases

2021 Volume 8, Issue 8, Page(s) ofab385

Abstract: We characterized the antibody composition of coronavirus disease 2019 (COVID-19) convalescent plasma (CCP) and the immunologic responses of hospitalized COVID-19 patients after receiving CCP or nonimmune fresh frozen plasma. Despite selection of CCP with ...

Abstract	We characterized the antibody composition of coronavirus disease 2019 (COVID-19) convalescent plasma (CCP) and the immunologic responses of hospitalized COVID-19 patients after receiving CCP or nonimmune fresh frozen plasma. Despite selection of CCP with significantly higher total immunoglobulin G than recipients, neutralizing antibody levels did not differ between donor plasma and CCP recipients.
Language	English
Publishing date	2021-07-16
Publishing country	United States
Document type	Journal Article
ZDB-ID	2757767-3
ISSN	2328-8957
ISSN	2328-8957
DOI	10.1093/ofid/ofab385
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Article ; Online: CD28 Costimulation: From Mechanism to Therapy.

Esensten, Jonathan H / Helou, Ynes A / Chopra, Gaurav / Weiss, Arthur / Bluestone, Jeffrey A

Immunity

2016 Volume 44, Issue 5, Page(s) 973–988

Abstract: Ligation of the CD28 receptor on T cells provides a critical second signal alongside T cell receptor (TCR) ligation for naive T cell activation. Here, we discuss the expression, structure, and biochemistry of CD28 and its ligands. CD28 signals play a key ...

Abstract	Ligation of the CD28 receptor on T cells provides a critical second signal alongside T cell receptor (TCR) ligation for naive T cell activation. Here, we discuss the expression, structure, and biochemistry of CD28 and its ligands. CD28 signals play a key role in many T cell processes, including cytoskeletal remodeling, production of cytokines, survival, and differentiation. CD28 ligation leads to unique epigenetic, transcriptional, and post-translational changes in T cells that cannot be recapitulated by TCR ligation alone. We discuss the function of CD28 and its ligands in both effector and regulatory T cells. CD28 is critical for regulatory T cell survival and the maintenance of immune homeostasis. We outline the roles that CD28 and its family members play in human disease and we review the clinical efficacy of drugs that block CD28 ligands. Despite the centrality of CD28 and its family members and ligands to immune function, many aspects of CD28 biology remain unclear. Translation of a basic understanding of CD28 function into immunomodulatory therapeutics has been uneven, with both successes and failures. Such real-world results might stem from multiple factors, including complex receptor-ligand interactions among CD28 family members, differences between the mouse and human CD28 families, and cell-type specific roles of CD28 family members.
MeSH term(s)	Abatacept/therapeutic use ; Animals ; Autoimmune Diseases/genetics ; Autoimmune Diseases/immunology ; Autoimmune Diseases/therapy ; CD28 Antigens/genetics ; CD28 Antigens/immunology ; CD28 Antigens/metabolism ; CTLA-4 Antigen/antagonists & inhibitors ; Homeostasis ; Humans ; Immunotherapy/methods ; Immunotherapy/trends ; Lymphocyte Activation ; Mice ; Molecular Targeted Therapy ; Receptor Cross-Talk ; Receptors, Antigen, T-Cell/metabolism ; Signal Transduction ; T-Lymphocytes/immunology
Chemical Substances	CD28 Antigens ; CTLA-4 Antigen ; CTLA4 protein, human ; Receptors, Antigen, T-Cell ; Abatacept (7D0YB67S97)
Language	English
Publishing date	2016-05-18
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	1217235-2
ISSN	1097-4180 ; 1074-7613
ISSN (online)	1097-4180
ISSN	1074-7613
DOI	10.1016/j.immuni.2016.04.020
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Zs.MG 69: Show issues

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Article ; Online: Magnitude and Kinetics of Anti-Severe Acute Respiratory Syndrome Coronavirus 2 Antibody Responses and Their Relationship to Disease Severity.

Lynch, Kara L / Whitman, Jeffrey D / Lacanienta, Noreen P / Beckerdite, Erica W / Kastner, Shannon A / Shy, Brian R / Goldgof, Gregory M / Levine, Andrew G / Bapat, Sagar P / Stramer, Susan L / Esensten, Jonathan H / Hightower, Allen W / Bern, Caryn / Wu, Alan H B

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

2021 Volume 72, Issue 2, Page(s) 301–308

Abstract: Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection can be detected indirectly by measuring the host immune response. For some viruses, antibody concentrations correlate with host protection and viral neutralization, but ... ...

Abstract	Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection can be detected indirectly by measuring the host immune response. For some viruses, antibody concentrations correlate with host protection and viral neutralization, but in rare cases, antiviral antibodies can promote disease progression. Elucidation of the kinetics and magnitude of the SARS-CoV-2 antibody response is essential to understand the pathogenesis of coronavirus disease 2019 (COVID-19) and identify potential therapeutic targets. Methods: Sera (n = 533) from patients with real-time polymerase chain reaction-confirmed COVID-19 (n = 94 with acute infections and n = 59 convalescent patients) were tested using a high-throughput quantitative immunoglobulin M (IgM) and immunoglobulin G (IgG) assay that detects antibodies to the spike protein receptor binding domain and nucleocapsid protein. Individual and serial samples covered the time of initial diagnosis, during the disease course, and following recovery. We evaluated antibody kinetics and correlation between magnitude of the response and disease severity. Results: Patterns of SARS-CoV-2 antibody production varied considerably. Among 52 patients with 3 or more serial specimens, 44 (84.6%) and 42 (80.8%) had observed IgM and IgG seroconversion at a median of 8 and 10 days, respectively. Compared to those with milder disease, peak measurements were significantly higher for patients admitted to the intensive care unit for all time intervals between 6 and 20 days for IgM, and all intervals after 5 days for IgG. Conclusions: High-sensitivity assays with a robust dynamic range provide a comprehensive picture of host antibody response to SARS-CoV-2. IgM and IgG responses were significantly higher in patients with severe than mild disease. These differences may affect strategies for seroprevalence studies, therapeutics, and vaccine development.
MeSH term(s)	Antibodies, Viral ; Antibody Formation ; COVID-19 ; Humans ; Immunoglobulin M ; Kinetics ; SARS-CoV-2 ; Seroepidemiologic Studies ; Severity of Illness Index
Chemical Substances	Antibodies, Viral ; Immunoglobulin M
Language	English
Publishing date	2021-03-01
Publishing country	United States
Document type	Journal Article
ZDB-ID	1099781-7
ISSN	1537-6591 ; 1058-4838
ISSN (online)	1537-6591
ISSN	1058-4838
DOI	10.1093/cid/ciaa979
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Article ; Online: High-yield genome engineering in primary cells using a hybrid ssDNA repair template and small-molecule cocktails.

Nature biotechnology

2022 Volume 41, Issue 4, Page(s) 521–531

Abstract: Enhancing CRISPR-mediated site-specific transgene insertion efficiency by homology-directed repair (HDR) using high concentrations of double-stranded DNA (dsDNA) with Cas9 target sequences (CTSs) can be toxic to primary cells. Here, we develop single- ... ...

Abstract	Enhancing CRISPR-mediated site-specific transgene insertion efficiency by homology-directed repair (HDR) using high concentrations of double-stranded DNA (dsDNA) with Cas9 target sequences (CTSs) can be toxic to primary cells. Here, we develop single-stranded DNA (ssDNA) HDR templates (HDRTs) incorporating CTSs with reduced toxicity that boost knock-in efficiency and yield by an average of around two- to threefold relative to dsDNA CTSs. Using small-molecule combinations that enhance HDR, we could further increase knock-in efficiencies by an additional roughly two- to threefold on average. Our method works across a variety of target loci, knock-in constructs and primary human cell types, reaching HDR efficiencies of >80-90%. We demonstrate application of this approach for both pathogenic gene variant modeling and gene-replacement strategies for IL2RA and CTLA4 mutations associated with Mendelian disorders. Finally, we develop a good manufacturing practice (GMP)-compatible process for nonviral chimeric antigen receptor-T cell manufacturing, with knock-in efficiencies (46-62%) and yields (>1.5 × 10
MeSH term(s)	Humans ; CRISPR-Cas Systems/genetics ; DNA, Single-Stranded/genetics ; Genome ; Recombinational DNA Repair ; Mutation ; DNA ; Gene Editing ; DNA End-Joining Repair
Chemical Substances	DNA, Single-Stranded ; DNA (9007-49-2)
Language	English
Publishing date	2022-08-25
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	1311932-1
ISSN	1546-1696 ; 1087-0156
ISSN (online)	1546-1696
ISSN	1087-0156
DOI	10.1038/s41587-022-01418-8
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