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Characterization of HLH-Like Manifestations as a CRS Variant in Patients Receiving CD22 CAR T-Cells.

Daniel A Lichtenstein, Fiorella Schischlik, Lipei Shao, Seth M Steinberg, Bonnie Yates, Hao-Wei Wang, Yanyu Wang, Jon Inglefield, Alina Dulau Florea, Francesco Ceppi, Leandro C Hermida, Kate Stringaris, Kim Dunham, Philip John Homan, Parthav Jailwala, Justin Mateen Mirazee, Welles Robinson, Karen Chisholm, Constance M Yuan, Maryalice Stetler-Stevenson, Amanda K Ombrello, Jianjian Jin, Terry J Fry, Naomi Taylor, Steven L Highfill, Ping Jin, Rebecca A Gardner, Haneen Shalabi, Eytan Ruppin, David F Stroncek, Nirali N Shah,

CAR T-cell toxicities resembling hemophagocytic lymphohistiocytosis (HLH) occur in a subset of patients with cytokine release syndrome (CRS). As a variant of conventional CRS, a comprehensive characterization of CAR T-cell associated HLH (carHLH) and investigations into associated risk factors are lacking. In the context of 59 patients infused with CD22 ... Read more >>

Blood (Blood)
[2021, :]

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BK virus-specific T cells for immunotherapy of progressive multifocal leukoencephalopathy: an open-label, single-cohort pilot study.

Irene Cortese, Erin S Beck, Omar Al-Louzi, Joan Ohayon, Frances Andrada, Ikesinachi Osuorah, Jenifer Dwyer, B Jeanne Billioux, Nigar Dargah-Zada, Matthew K Schindler, Kyle Binder, Lauren Reoma, Gina Norato, Yoshimi Enose-Akahata, Bryan R Smith, Maria Chiara Monaco, Eugene O Major, Steven Jacobson, David Stroncek, Steven Highfill, Sandhya Panch, Daniel S Reich, John Barrett, Avindra Nath, Pawel Muranski,

<h4>Background</h4>Progressive multifocal leukoencephalopathy, a rare disease of the CNS caused by JC virus and occurring in immunosuppressed people, is typically fatal unless adaptive immunity is restored. JC virus is a member of the human polyomavirus family and is closely related to the BK virus. We hypothesised that use of partly ... Read more >>

Lancet Neurol (The Lancet. Neurology)
[2021, 20(8):639-652]

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Challenges and next steps in the advancement of immunotherapy: summary of the 2018 and 2020 National Cancer Institute workshops on cell-based immunotherapy for solid tumors.

Laura K Fogli, Rosemarie Aurigemma, Connie L Sommers, Anju Singh, Kasia Bourcier, Marc S Ernstoff, ,

Cell-based immunotherapies have had remarkable success in the clinic, specifically in the treatment of hematologic malignancies. However, these strategies have had limited efficacy in patients with solid tumors. To better understand the challenges involved, the National Cancer Institute (NCI) convened an initial workshop with immuno-oncology thought leaders in December 2018 ... Read more >>

J Immunother Cancer (Journal for immunotherapy of cancer)
[2021, 9(7):]

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Combined haploidentical and cord blood transplantation for refractory severe aplastic anaemia and hypoplastic myelodysplastic syndrome.

Richard W Childs, Xin Tian, Phuong Vo, Enkhtsetseg Purev, Ritesh R Kotecha, Mattias Carlsten, Joseph Clara, Willy A Flegel, Sharon D Adams, Hanh M Khuu, David F Stroncek, Lisa Cook, Tat'yana Worthy, Nancy L Geller, Brian Wells, Jennifer Wilder, Robert Reger, Georg Aue,

Umbilical cord blood (UCB) transplantation is a potentially curative treatment for patients with refractory severe aplastic anaemia (SAA), but has historically been associated with delayed engraftment and high graft failure and mortality rates. We conducted a prospective phase 2 trial to assess outcome of an allogeneic transplant regimen that co-infused ... Read more >>

Br J Haematol (British journal of haematology)
[2021, 193(5):951-960]

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Disease severity impacts plerixafor-mobilized stem cell collection in patients with sickle cell disease.

Alexis Leonard, Akshay Sharma, Naoya Uchida, David Stroncek, Sandhya R Panch, Kamille West, Eoghan Molloy, Thomas E Hughes, Sara Hauffe, Tiffani Taylor, Courtney Fitzhugh, Jane S Hankins, Megan Wilson, Shengdar Q Tsai, Mitchell J Weiss, Matthew Hsieh, John F Tisdale,

Recent studies suggest that plerixafor mobilization and apheresis in patients with sickle cell disease (SCD) is safe and can allow collection of sufficient CD34+ hematopoietic stem cell (HSC) collection for clinical gene therapy applications. However, the quantities of plerixafor-mobilized CD34+ cells vary between different SCD patients for unknown reasons. Twenty-three ... Read more >>

Blood Adv (Blood advances)
[2021, 5(9):2403-2411]

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Self-organized yolk sac-like organoids allow for scalable generation of multipotent hematopoietic progenitor cells from human induced pluripotent stem cells

Naritaka Tamaoki, Stefan Siebert, Takuya Maeda, Ngoc-Han Ha, Meghan Good, Yin Huang, Suman Kumar Vodnala, Juan J.Haro Mora, Uchida Naoya, John Tisdale, Colin Sweeney, Uimook Choi, Julie Brault, Sherry Koontz, Harry Malech, Yasuhiro Yamazaki, Risa Isonaka, David Goldstein, Masaki Kimura, Takanori Takebe, Jizhong Zou, David Stroncek, Pamela Robey, Michael Kruhlak, Nicholas Restifo, Raul Vizcardo,

The human definitive yolk sac is an important organ supporting the early developing embryo through nutrient supply and by facilitating the establishment of the embryonic circulatory system. However, the molecular and cellular biology of the human yolk sac remains largely obscure due to the lack of suitable in vitro models. ... Read more >>

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Shorter Interdonation Interval Contributes to Lower Cell Counts in Subsequent Stem Cell Donations.

Sandhya R Panch, Brent Logan, Jennifer A Sees, Stephanie Bo-Subait, Bipin Savani, Nirali N Shah, Jack W Hsu, Galen Switzer, Hillard M Lazarus, Paolo Anderlini, Peiman Hematti, Dennis Confer, Michael A Pulsipher, Bronwen E Shaw, David F Stroncek,

Approximately 7% of unrelated hematopoietic stem cell donors are asked to donate stem cells a subsequent time to the same or a different recipient. Recent studies have shown that donation-related symptoms for second donations are similar to those for the first donation. Little is known about differences in stem cell ... Read more >>

Transplant Cell Ther (Transplantation and cellular therapy)
[2021, 27(6):503.e1-503.e8]

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Long-Term Follow-Up of CD19-CAR T-Cell Therapy in Children and Young Adults With B-ALL.

Nirali N Shah, Daniel W Lee, Bonnie Yates, Constance M Yuan, Haneen Shalabi, Staci Martin, Pamela L Wolters, Seth M Steinberg, Eva H Baker, Cindy P Delbrook, Maryalice Stetler-Stevenson, Terry J Fry, David F Stroncek, Crystal L Mackall,

<h4>Purpose</h4>CD19 chimeric antigen receptor (CD19-CAR) T cells induce high response rates in children and young adults (CAYAs) with B-cell acute lymphoblastic leukemia (B-ALL), but relapse rates are high. The role for allogeneic hematopoietic stem-cell transplant (alloHSCT) following CD19-CAR T-cell therapy to improve long-term outcomes in CAYAs has not been examined.<h4>Methods</h4>We ... Read more >>

J Clin Oncol (Journal of clinical oncology : official journal of the American Society of Clinical Oncology)
[2021, 39(15):1650-1659]

Cited: 2 times

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A link between IL-23 and anti-CD4 autoantibody production in antiretroviral-treated HIV-infected individuals.

Zhenwu Luo, Min Li, Fuli Mi, Zhefeng Meng, Guoqiang Du, Lisa Martin, Hui Liu, Ping Jin, David Stroncek, Sonya L Heath, Wei Jiang,

Potential mechanisms of poor CD4+ T cell reconstitution after viral suppression with antiretroviral therapy (ART) in HIV disease have been extensively investigated. We recently discovered that anti-CD4 autoantibody plays a role in impaired CD4+ T cell recovery from ART in HIV-infected individuals with viral suppression, which accounts for a mechanism ... Read more >>

J Virol (Journal of virology)
[2021, :]

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Robust Antitumor Activity and Low Cytokine Production by Novel Humanized Anti-CD19 CAR T Cells.

Alka Dwivedi, Atharva Karulkar, Sarbari Ghosh, Srisathya Srinivasan, Bajarang Vasant Kumbhar, Ankesh Kumar Jaiswal, Atish Kizhakeyil, Sweety Asija, Afrin Rafiq, Sushant Kumar, Albeena Nisar, Deepali Pandit Patil, Minal Vivek Poojary, Hasmukh Jain, Shripad D Banavali, Steven L Highfill, David F Stroncek, Nirali N Shah, Terry J Fry, Gaurav Narula, Rahul Purwar,

Recent studies have described the remarkable clinical outcome of anti-CD19 chimeric antigen receptor (CAR) T cells in treating B-cell malignancies. However, over 50% of patients develop life-threatening toxicities associated with cytokine release syndrome which may limit its utilization in low-resource settings. To mitigate the toxicity, we designed a novel humanized ... Read more >>

Mol Cancer Ther (Molecular cancer therapeutics)
[2021, 20(5):846-858]

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TCR-engineered T cells targeting E7 for patients with metastatic HPV-associated epithelial cancers.

Nisha B Nagarsheth, Scott M Norberg, Andrew L Sinkoe, Sabina Adhikary, Thomas J Meyer, Justin B Lack, Andrew C Warner, Colleen Schweitzer, Stacey L Doran, Soumya Korrapati, Sanja Stevanović, Cornelia L Trimble, Jennifer A Kanakry, Mohammad Hadi Bagheri, Erin Ferraro, Stephanie H Astrow, Adrian Bot, William C Faquin, David Stroncek, Nikolaos Gkitsas, Steven Highfill, Christian S Hinrichs,

Genetically engineered T cell therapy can induce remarkable tumor responses in hematologic malignancies. However, it is not known if this type of therapy can be applied effectively to epithelial cancers, which account for 80-90% of human malignancies. We have conducted a first-in-human, phase 1 clinical trial of T cells engineered ... Read more >>

Nat Med (Nature medicine)
[2021, 27(3):419-425]

Cited: 4 times

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Establishment of a cell processing laboratory to support hematopoietic stem cell transplantation and chimeric antigen receptor (CAR)-T cell therapy.

Somnath Mukherjee, Opal Reddy, Sandhya Panch, David Stroncek,

Cell processing laboratories are an important part of cancer treatment centers. Cell processing laboratories began by supporting hematopoietic stem cell (HSC) transplantation programs. These laboratories adapted closed bag systems, centrifuges, sterile connecting devices and other equipment used in transfusion services/blood banks to remove red blood cells and plasma from marrow ... Read more >>

Transfus Apher Sci (Transfusion and apheresis science : official journal of the World Apheresis Association : official journal of the European Society for Haemapheresis)
[2021, 60(1):103066]

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Inhibition of adjuvant-induced TAM receptors potentiates cancer vaccine immunogenicity and therapeutic efficacy.

Diana Llopiz, Marta Ruiz, Leyre Silva, David Repáraz, Belén Aparicio, Josune Egea, Juan J Lasarte, Esther Redin, Alfonso Calvo, Matthew Angel, Jay A Berzofsky, David Stroncek, Pablo Sarobe,

Analyzing immunomodulatory elements operating during antitumor vaccination in prostate cancer patients and murine models we identified IL-10-producing DC as a subset with poorer immunogenicity and clinical efficacy. Inhibitory TAM receptors MER and AXL were upregulated on murine IL-10<sup>+</sup> DC. Thus, we analyzed conditions inducing these molecules and the potential benefit ... Read more >>

Cancer Lett (Cancer letters)
[2021, 499:279-289]

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Safe and efficient peripheral blood stem cell collection in patients with sickle cell disease using plerixafor.

Naoya Uchida, Alexis Leonard, David Stroncek, Sandhya R Panch, Kamille West, Eoghan Molloy, Thomas E Hughes, Sara Hauffe, Tiffani Taylor, Courtney Fitzhugh, Jane S Hankins, Megan Wilson, Akshay Sharma, Shengdar Q Tsai, Mitch J Weiss, Matthew Hsieh, John F Tisdale,

Haematologica (Haematologica)
[2020, 105(10):e497]

Cited: 7 times

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Human Mesenchymal Stromal Cell (MSC) Characteristics Vary Among Laboratories When Manufactured From the Same Source Material: A Report by the Cellular Therapy Team of the Biomedical Excellence for Safer Transfusion (BEST) Collaborative.

David F Stroncek, Ping Jin, David H McKenna, Minoko Takanashi, Magali J Fontaine, Shibani Pati, Richard Schäfer, Emily Peterson, Eric Benedetti, Jo-Anna Reems,

<h4>Background</h4>Culture-derived mesenchymal stromal cells (MSCs) exhibit variable characteristics when manufactured using different methods and different source materials. The purpose of this study was to assess the impact on MSC characteristics when different laboratories propagated MSCs from cultures initiated with BM aliquots derived from the same donor source material.<h4>Methods and methods</h4>Five ... Read more >>

Front Cell Dev Biol (Frontiers in cell and developmental biology)
[2020, 8:458]

Cited: 4 times

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Application of Droplet Digital PCR for the Detection of Vector Copy Number in Clinical CAR/TCR T-Cell Products

Alex Lu, Hui Liu, Rongye Shi, Yihua Cai, Jinxia Ma, Lipei Shao, Victor Rong, Nikolaos Gkitsas, Hong Lei, Steven Highfill, Sandhya Panch, David Stroncek, Ping Jin,

<h4>Background: </h4> Genetically engineered T cells have become an important therapy for B-cell malignancies. Measuring the efficiency of vector integration into the T cell genome is important for assessing the potency and safety of these cancer immunotherapies. <h4>Methods:</h4> A digital droplet polymerase chain reaction (ddPCR) assay was developed and evaluated ... Read more >>

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Application of droplet digital PCR for the detection of vector copy number in clinical CAR/TCR T cell products.

Alex Lu, Hui Liu, Rongye Shi, Yihua Cai, Jinxia Ma, Lipei Shao, Victor Rong, Nikolaos Gkitsas, Hong Lei, Steven L Highfill, Sandhya Panch, David F Stroncek, Ping Jin,

<h4>Background</h4>Genetically engineered T cells have become an important therapy for B-cell malignancies. Measuring the efficiency of vector integration into the T cell genome is important for assessing the potency and safety of these cancer immunotherapies.<h4>Methods</h4>A digital droplet polymerase chain reaction (ddPCR) assay was developed and evaluated for assessing the average ... Read more >>

J Transl Med (Journal of translational medicine)
[2020, 18(1):191]

Cited: 1 time

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CD4/CD8 T-Cell Selection Affects Chimeric Antigen Receptor (CAR) T-Cell Potency and Toxicity: Updated Results From a Phase I Anti-CD22 CAR T-Cell Trial.

Nirali N Shah, Steven L Highfill, Haneen Shalabi, Bonnie Yates, Jianjian Jin, Pamela L Wolters, Amanda Ombrello, Seth M Steinberg, Staci Martin, Cindy Delbrook, Leah Hoffman, Lauren Little, Anusha Ponduri, Haiying Qin, Haris Qureshi, Alina Dulau-Florea, Dalia Salem, Hao-Wei Wang, Constance Yuan, Maryalice Stetler-Stevenson, Sandhya Panch, Minh Tran, Crystal L Mackall, David F Stroncek, Terry J Fry,

<h4>Purpose</h4>Patients with B-cell acute lymphoblastic leukemia who experience relapse after or are resistant to CD19-targeted immunotherapies have limited treatment options. Targeting CD22, an alternative B-cell antigen, represents an alternate strategy. We report outcomes on the largest patient cohort treated with CD22 chimeric antigen receptor (CAR) T cells.<h4>Patients and methods</h4>We conducted ... Read more >>

J Clin Oncol (Journal of clinical oncology : official journal of the American Society of Clinical Oncology)
[2020, 38(17):1938-1950]

Cited: 40 times

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Transfusion support in patients with hematologic disease: Transfusions in special clinical circumstances.

Sandhya Panch, Bipin N Savani, David Stroncek,

Semin Hematol (Seminars in hematology)
[2020, 57(2):31-32]

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Author Correction: Safety and feasibility of anti-CD19 CAR T cells with fully human binding domains in patients with B-cell lymphoma.

Jennifer N Brudno, Norris Lam, Danielle Vanasse, Yueh-Wei Shen, Jeremy J Rose, John Rossi, Allen Xue, Adrian Bot, Nathalie Scholler, Lekha Mikkilineni, Mark Roschewski, Robert Dean, Raul Cachau, Philippe Youkharibache, Rashmika Patel, Brenna Hansen, David F Stroncek, Steven A Rosenberg, Ronald E Gress, James N Kochenderfer,

An amendment to this paper has been published and can be accessed via a link at the top of the paper. ... Read more >>

Nat Med (Nature medicine)
[2020, 26(5):803]

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Variations in novel cellular therapy products manufacturing.

Magali J Fontaine, Eileen Selogie, David Stroncek, David McKenna, Zbigniew M Szczepiorkowski, Minoko Takanashi, Henk Garritsen, John Girdlestone, Jo-Anna Reems, ,

<h4>Background aims</h4>At the frontier of transfusion medicine and transplantation, the field of cellular therapy is emerging. Most novel cellular therapy products are produced under investigational protocols with no clear standardization across cell processing centers. Thus, the purpose of this study was to uncover any variations in manufacturing practices for similar ... Read more >>

Cytotherapy (Cytotherapy)
[2020, 22(6):337-342]

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Advances in gene therapy for hematologic disease and considerations for transfusion medicine.

Opal L Reddy, Bipin N Savani, David F Stroncek, Sandhya R Panch,

As the list of regulatory agency-approved gene therapies grows, these products are now in the therapeutic spotlight with the potential to cure or dramatically alleviate several benign and malignant hematologic diseases. The mechanisms for gene manipulation are diverse, and include the use of a variety of cell sources and both ... Read more >>

Semin Hematol (Seminars in hematology)
[2020, 57(2):83-91]

Cited: 1 time

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Group O plasma as a media supplement for CAR-T cells and other adoptive T-cell therapies.

Randin C Nelson, Vicki Fellowes, Ping Jin, Hui Liu, Steven L Highfill, Jiaqiang Ren, James Szymanski, Willy A Flegel, David F Stroncek,

<h4>Background</h4>Most chimeric antigen receptor T (CAR-T) cells and other adoptive T-cell therapies (ACTs) are currently manufactured by ex vivo expansion of patient lymphocytes in culture media supplemented with human plasma from group AB donors. As lymphocytes do not express A or B antigens, the isoagglutinins of non-AB plasmas are unlikely ... Read more >>

Transfusion (Transfusion)
[2020, 60(5):1004-1014]

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Transfusion of Uncrossmatched Group O Erythrocyte-containing Products Does Not Interfere with Most ABO Typings.

Mark H Yazer, Philip C Spinella, Leilani Doyle, Richard M Kaufman, Robyn Dunn, John R Hess, Luiz Amorim Filho, Magali Fontaine, Birgit Gathof, Bryon Jackson, Michael F Murphy, Jeremiah Pasion, Jay S Raval, Kristin Rosinski, Jansen Seheult, Andrew W Shih, Jason Sperry, Julie Staves, Erin E Tuott, Alyssa Ziman, Darrell J Triulzi, ,

<h4>Background</h4>Group O erythrocytes and/or whole blood are used for urgent transfusions in patients of unknown blood type. This study investigated the impact of transfusing increasing numbers of uncrossmatched type O products on the recipient's first in-hospital ABO type.<h4>Methods</h4>This was a retrospective cohort study. Results of the first ABO type obtained ... Read more >>

Anesthesiology (Anesthesiology)
[2020, 132(3):525-534]

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Safety and feasibility of anti-CD19 CAR T cells with fully human binding domains in patients with B-cell lymphoma.

Jennifer N Brudno, Norris Lam, Danielle Vanasse, Yueh-Wei Shen, Jeremy J Rose, John Rossi, Allen Xue, Adrian Bot, Nathalie Scholler, Lekha Mikkilineni, Mark Roschewski, Robert Dean, Raul Cachau, Philippe Youkharibache, Rashmika Patel, Brenna Hansen, David F Stroncek, Steven A Rosenberg, Ronald E Gress, James N Kochenderfer,

Anti-CD19 chimeric antigen receptor (CAR)-expressing T cells are an effective treatment for B-cell lymphoma, but often cause neurologic toxicity. We treated 20 patients with B-cell lymphoma on a phase I, first-in-human clinical trial of T cells expressing the new anti-CD19 CAR Hu19-CD828Z (NCT02659943). The primary objective was to assess safety ... Read more >>

Nat Med (Nature medicine)
[2020, 26(2):270-280]

Cited: 35 times

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