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Article ; Online: CAR T-Cells for Cure in Pediatric B-ALL.

Gardner, Rebecca A / Shah, Nirali N

Journal of clinical oncology : official journal of the American Society of Clinical Oncology

2023 Volume 41, Issue 9, Page(s) 1646–1648

MeSH term(s)	Humans ; Child ; Receptors, Antigen, T-Cell/genetics ; Receptors, Chimeric Antigen ; T-Lymphocytes ; Immunotherapy, Adoptive ; Antigens, CD19
Chemical Substances	Receptors, Antigen, T-Cell ; Receptors, Chimeric Antigen ; Antigens, CD19
Language	English
Publishing date	2023-01-12
Publishing country	United States
Document type	Editorial ; Comment
ZDB-ID	604914-x
ISSN	1527-7755 ; 0732-183X
ISSN (online)	1527-7755
ISSN	0732-183X
DOI	10.1200/JCO.22.02345
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Zs.MO 650: Show issues

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Article ; Online: Chimeric Antigen Receptor T Cells for B-Cell Acute Lymphoblastic Leukemia.

Ceppi, Francesco / Gardner, Rebecca A

Cancer journal (Sudbury, Mass.)

2019 Volume 25, Issue 3, Page(s) 191–198

Abstract: Chimeric antigen receptor (CAR) T-cell therapy is transforming the landscape for treatment of B-lineage acute lymphoblastic leukemia (B-ALL). Chimeric antigen receptor T-cell therapy makes use of T cells that have been modified to target a cancer- ... ...

Abstract	Chimeric antigen receptor (CAR) T-cell therapy is transforming the landscape for treatment of B-lineage acute lymphoblastic leukemia (B-ALL). Chimeric antigen receptor T-cell therapy makes use of T cells that have been modified to target a cancer-specific cell surface antigen. There is currently 1 Food and Drug Administration-approved CD19-directed CAR T-cell therapy for relapsed/refractory B-ALL with numerous other CAR T-cell products under clinical investigation. This review covers the development of CAR T cells for B-ALL, citing the remarkable efficacy of inducing remissions in a very high-risk population of patients. However, following the first round of CAR T-cell trials targeting CD19 in B-ALL, it has been found that approximately 50% of patients who initially respond will ultimately recur. Current efforts in the field are focusing on the identification of targets beyond CD19 as well as advancing strategies to promote more durable remissions as work is ongoing to move this therapy upfront.
MeSH term(s)	Animals ; Antigens, Neoplasm/metabolism ; Biomarkers ; Cancer Vaccines ; Clinical Trials as Topic ; Humans ; Immunotherapy, Adoptive/adverse effects ; Immunotherapy, Adoptive/methods ; Precursor B-Cell Lymphoblastic Leukemia-Lymphoma/diagnosis ; Precursor B-Cell Lymphoblastic Leukemia-Lymphoma/etiology ; Precursor B-Cell Lymphoblastic Leukemia-Lymphoma/metabolism ; Precursor B-Cell Lymphoblastic Leukemia-Lymphoma/therapy ; Receptors, Antigen, T-Cell/genetics ; Receptors, Antigen, T-Cell/metabolism ; Receptors, Chimeric Antigen/genetics ; Receptors, Chimeric Antigen/metabolism ; T-Lymphocytes/immunology ; T-Lymphocytes/metabolism ; T-Lymphocytes/pathology ; Tumor Escape ; Vaccination
Chemical Substances	Antigens, Neoplasm ; Biomarkers ; Cancer Vaccines ; Receptors, Antigen, T-Cell ; Receptors, Chimeric Antigen
Language	English
Publishing date	2019-05-27
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2018400-1
ISSN	1540-336X ; 1528-9117 ; 1081-4442
ISSN (online)	1540-336X
ISSN	1528-9117 ; 1081-4442
DOI	10.1097/PPO.0000000000000375
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Zs.A 4470: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: How Many Tests Does It Take to Diagnose a Triple-Hit B-Lymphoblastic Lymphoma? (Hint, It's A Lot).

Das, Marie / Tsuchiya, Karen D / Bohling, Sandra D / Davis, Billy / Hwang, Samuel / Gardner, Rebecca A / Chisholm, Karen M

Pediatric and developmental pathology : the official journal of the Society for Pediatric Pathology and the Paediatric Pathology Society

2023 Volume 27, Issue 2, Page(s) 193–197

Abstract: B-lymphoblastic leukemia/lymphoma (B-ALL/LBL) is a precursor B-cell neoplasm that often harbors specific cytogenetic/molecular abnormalities with distinctive clinical, phenotypic, and prognostic characteristics. Subcategorization of B-ALL/LBL therefore ... ...

Abstract	B-lymphoblastic leukemia/lymphoma (B-ALL/LBL) is a precursor B-cell neoplasm that often harbors specific cytogenetic/molecular abnormalities with distinctive clinical, phenotypic, and prognostic characteristics. Subcategorization of B-ALL/LBL therefore requires extensive cytogenetic and/or molecular testing to determine the appropriate classification and therapeutic interventions for these patients. Herein, we present a case of a 17-year-old young woman diagnosed with B-LBL harboring not only an
MeSH term(s)	Female ; Humans ; Adolescent ; Proto-Oncogene Proteins c-myc/genetics ; Proto-Oncogene Proteins c-bcl-2/genetics ; Proto-Oncogene Proteins c-bcl-2/therapeutic use ; Lymphoma, B-Cell/diagnosis ; Lymphoma, B-Cell/genetics ; Lymphoma, B-Cell/drug therapy ; Prognosis ; Precursor Cell Lymphoblastic Leukemia-Lymphoma ; Gene Rearrangement
Chemical Substances	Proto-Oncogene Proteins c-myc ; Proto-Oncogene Proteins c-bcl-2
Language	English
Publishing date	2023-11-30
Publishing country	United States
Document type	Case Reports ; Journal Article
ZDB-ID	1463498-3
ISSN	1615-5742 ; 1093-5266
ISSN (online)	1615-5742
ISSN	1093-5266
DOI	10.1177/10935266231212337
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Zs.A 5063: Show issues

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Article ; Online: Development of a Safety Surveillance Plan for the Academic Medicine Sponsor Performing First-in-Human Cellular Therapy Clinical Trials: A Report from the Consortium for Pediatric Cellular Immunotherapy.

Adams, Cheri / Keller, Michael / Michlitsch, Jennifer G / Aguayo-Hiraldo, Paibel / Chen, Karin / Hossain, Mohammad Z / Davis, Ann / Park, Julie R / Verneris, Michael R / Gardner, Rebecca A

Transplantation and cellular therapy

2024 Volume 30, Issue 5, Page(s) 475–487

Abstract: Pharmacovigilance (PV), also known as drug safety, is the science of risk management involving the detection, assessment, understanding, and prevention of adverse effects related to a medication. This discipline has traditionally focused on the ... ...

Abstract	Pharmacovigilance (PV), also known as drug safety, is the science of risk management involving the detection, assessment, understanding, and prevention of adverse effects related to a medication. This discipline has traditionally focused on the postmarketing period, with less attention to early-phase clinical trials. However, during the immunotherapy and cellular therapy investigational stage, regulatory agencies are increasingly emphasizing the need to identify and characterize safety signals earlier in clinical development as part of a comprehensive safety surveillance plan. Compliance with PV and safety regulations are further heightened as cell and gene therapy (CGT) trials grow in complexity and scope owing to ever-changing and increasingly rigorous regulatory mandates. Based on this changing landscape, a critical aspect of early-phase trials of cellular products where significant safety events are anticipated is to ensure that every effort is made to protect clinical trial participants by maximizing attention to the risk-versus-benefit profile. This includes the development of robust plans for safety surveillance that provide a continual assessment of safety signals to enable safety reporting to regulatory bodies and the Food and Drug Administration, a regular analysis of aggregate safety data, and a plan to communicate safety findings. This report focuses on PV in early-phase clinical trials of first-in-human investigational products sponsored by academic centers in which the availability of PV resources and subject matter experts is limited. To more fully understand the challenges of CGT PV oversight within pediatric academic medical centers conducting early-phase clinical trials, a working group from institutions participating in the Consortium for Pediatric Cellular Immunotherapy composed of faculty and regulatory professionals was convened to compare experiences, identify best practices, and review published literature to identify commonalities and opportunities for alignment. Here we present guidelines on PV planning in early-phase CGT clinical trials occurring in academic medical centers and offer strategies to mitigate risk to trial participants. Standards to address regulatory requirements and governance for safety signal identification and risk assessment are discussed.
MeSH term(s)	Humans ; Cell- and Tissue-Based Therapy/standards ; Cell- and Tissue-Based Therapy/methods ; Immunotherapy/adverse effects ; Immunotherapy/legislation & jurisprudence ; Immunotherapy/methods ; Clinical Trials as Topic/legislation & jurisprudence ; Pharmacovigilance ; Product Surveillance, Postmarketing
Language	English
Publishing date	2024-03-04
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	3062231-1
ISSN	2666-6367
ISSN (online)	2666-6367
DOI	10.1016/j.jtct.2024.02.022
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Zs.A 5082: Show issues

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Article ; Online: Risk of T-cell Malignancy Following CAR T cells in Children, Adolescents and Young Adults.

Lamble, Adam J / Schultz, Liora M / Nguyen, Khanh / Hsieh, Emily M / McNerney, Kevin / Rouce, Rayne H / Gardner, Rebecca A / Ghorashian, Sara / Shah, Nirali N / Maude, Shannon L

Blood advances

2024

Language	English
Publishing date	2024-05-03
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.2024013243
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Zs.A 7153: Show issues

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Article: CD19-redirected chimeric antigen receptor-modified T cells: a promising immunotherapy for children and adults with B-cell acute lymphoblastic leukemia (ALL).

Tasian, Sarah K / Gardner, Rebecca A

Therapeutic advances in hematology

2015 Volume 6, Issue 5, Page(s) 228–241

Abstract: Relapsed and chemotherapy-refractory B-cell acute lymphoblastic leukemia (B-ALL) remain significant causes of cancer-associated morbidity and mortality for children and adults. Development of new molecularly targeted treatment strategies for patients ... ...

Abstract	Relapsed and chemotherapy-refractory B-cell acute lymphoblastic leukemia (B-ALL) remain significant causes of cancer-associated morbidity and mortality for children and adults. Development of new molecularly targeted treatment strategies for patients with high-risk B-ALL is thus a major preclinical and clinical priority. Adoptive cellular therapy with patient-derived human T cells genetically engineered to express CD19 redirected chimeric antigen receptors (CD19 CAR T cells) is one immunotherapeutic modality that has recently demonstrated remarkable efficacy in re-inducing remission in patients with multiply relapsed B-ALL. Investigative teams at several major cancer centers are currently conducting phase I clinical trials in children and/or adults with relapsed/refractory B-ALL to assess the safety and to identify the maximally tolerated dose of each group's CD19 CAR T-cell product. All groups have reported major clinical toxicities associated with CD19 CAR T-cell treatment, including cytokine release syndrome (CRS) and macrophage activation syndrome, neurologic dysfunction and aplasia of normal B lymphocytes, while CD19 CAR T cells persist in vivo. Toxicities have generally been transient or manageable with supportive care measures. Some patients with life-threatening CD19 CAR T-cell induced sequelae have received anti-cytokine receptor antibody treatment to diminish CRS symptoms and/or corticosteroids to terminate CAR T-cell proliferation. Remarkably, 67-90% of children and adults with B-ALL treated with CD19 CAR T cells in these trials have achieved morphologic leukemia remission with many patients also in molecular remission. The duration of CD19 CAR T cell persistence in vivo has varied appreciably among treated patients and likely reflects differences in the CD19 CAR constructs utilized at each institution. CD19-positive and CD19-negative B-ALL relapses after CD19 CAR T-cell treatment have occurred in some patients. Phase II trials to assess the efficacy of CD19 CAR T-cell immunotherapy in larger cohorts of patients with relapsed/refractory B-ALL are ongoing or planned.
Language	English
Publishing date	2015-08-24
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	2585183-4
ISSN	2040-6215 ; 2040-6207
ISSN (online)	2040-6215
ISSN	2040-6207
DOI	10.1177/2040620715588916
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Article ; Online: EEG Correlates of Delirium in Children and Young Adults With CD19-Directed CAR T Cell Treatment-Related Neurotoxicity.

Gust, Juliane / Annesley, Colleen E / Gardner, Rebecca A / Bozarth, Xiuhua

Journal of clinical neurophysiology : official publication of the American Electroencephalographic Society

2019 Volume 38, Issue 2, Page(s) 135–142

Abstract: Introduction: EEG patterns in chimeric antigen receptor T cell treatment-associated neurotoxicity (immune effector cell-associated neurotoxicity syndrome) have not yet been systematically studied. We tested the hypothesis that EEG background ... ...

Abstract	Introduction: EEG patterns in chimeric antigen receptor T cell treatment-associated neurotoxicity (immune effector cell-associated neurotoxicity syndrome) have not yet been systematically studied. We tested the hypothesis that EEG background abnormalities in immune effector cell-associated neurotoxicity syndrome correlate with clinical signs of neurotoxicity. In addition, we describe ictal and interictal EEG patterns to better understand the natural history of immune effector cell-associated neurotoxicity syndrome-associated seizures. Methods: EEGs were obtained in 19 of 100 subjects in a prospective cohort study of children and young adults undergoing CD19-directed chimeric antigen receptor T cell therapy. We classified the EEG background on a severity scale of 0 to 5 during 30-minute epochs. EEG grades were compared with neurotoxicity scored by Common Terminology Criteria for Adverse Events and Cornell Assessment of Pediatric Delirium scores. Descriptive analysis was conducted for ictal and interictal EEG abnormalities. Results: EEG background abnormality scores correlated well with Common Terminology Criteria for Adverse Events neurotoxicity scores (P = 0.0022) and Cornell Assessment of Pediatric Delirium scores (P = 0.0085). EEG was better able to differentiate the severity of coma patterns compared with the clinical scores. The EEG captured electroclinical seizures in 4 of 19 subjects, 3 of whom had additional electrographic-only seizures. Seizures most often arose from posterior head regions. Interictal epileptiform discharges were focal, multifocal, or lateralized periodic discharges. No seizures or interictal epileptiform abnormalities were seen in subjects without previous clinical seizures. Conclusions: Continuous EEG monitoring is high yield for seizure detection in high-risk chimeric antigen receptor T cell patients, and electrographic-only seizures are common. Increasing severity of EEG background abnormalities correlates with increasing neurotoxicity grade.
MeSH term(s)	Adolescent ; Antigens, CD19/adverse effects ; Child ; Child, Preschool ; Cohort Studies ; Delirium/diagnosis ; Delirium/etiology ; Delirium/physiopathology ; Electroencephalography/methods ; Female ; Humans ; Immunotherapy, Adoptive/adverse effects ; Male ; Monitoring, Physiologic/methods ; Neurotoxicity Syndromes/diagnosis ; Neurotoxicity Syndromes/physiopathology ; Prospective Studies ; Seizures/diagnosis ; Seizures/etiology ; Seizures/physiopathology ; Young Adult
Chemical Substances	Antigens, CD19 ; CD19 molecule, human
Language	English
Publishing date	2019-11-22
Publishing country	United States
Document type	Clinical Trial, Phase I ; Clinical Trial, Phase II ; Journal Article
ZDB-ID	605640-4
ISSN	1537-1603 ; 0736-0258
ISSN (online)	1537-1603
ISSN	0736-0258
DOI	10.1097/WNP.0000000000000669
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Article ; Online: CD19CAR T cells: From humble beginnings to cancer immunotherapy's poster child.

Gardner, Rebecca A / Jensen, Michael C

Cancer journal (Sudbury, Mass.)

2014 Volume 20, Issue 2, Page(s) 107–111

Abstract: The conceptual foundation and technical evolution of T-cell genetic engineering for the purpose of retargeting antigen specificity as a clinical immunotherapy modality in oncology have been decades in the making, with many laboratories providing ... ...

Abstract	The conceptual foundation and technical evolution of T-cell genetic engineering for the purpose of retargeting antigen specificity as a clinical immunotherapy modality in oncology have been decades in the making, with many laboratories providing important contributions to overall progress. The development of the component parts of this technology has required the amalgamation of divergent scientific disciplines including cellular immunology, lymphocyte signaling biology, molecular biology, vector virology, and practical improvements in T-cell culture systems. Together with advances in the understanding of clinical variables that facilitate persistent engraftment and expansion of adoptively transferred T cells, the field of CD19CAR research evolved as a logical venue for revealing proof-of-principle clinical antitumor activity. Indeed, the modality has definitively crossed the threshold from a preclinical model system to a therapeutic approach with demonstrable potent antileukemic efficacy in patients harboring advanced and refractory leukemias. The dramatic responses seen in CD19CAR T-cell clinical trials from multiple institutions does not signal an end to the evolution of CD19CAR T cells, as along with early clinical successes, new challenges have emerged that require further refinement of this nascent therapeutic platform.
MeSH term(s)	Antigens, CD19/genetics ; Antigens, CD19/immunology ; Antigens, CD19/therapeutic use ; Epitopes ; Genetic Engineering ; Humans ; Immunotherapy, Adoptive ; Neoplasms/immunology ; Neoplasms/therapy ; T-Lymphocytes/immunology
Chemical Substances	Antigens, CD19 ; Epitopes
Language	English
Publishing date	2014-03
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	2018400-1
ISSN	1540-336X ; 1528-9117 ; 1081-4442
ISSN (online)	1540-336X
ISSN	1528-9117 ; 1081-4442
DOI	10.1097/PPO.0000000000000030
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Zs.A 4470: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (2.OG) ab Jg. 2022: Lesesaal (EG)
Zs.MO 163: Show issues

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Article: Is intrachromosomal amplification of chromosome 21 (iAMP21) always intrachromosomal?

Tsuchiya, Karen D / Davis, Billy / Gardner, Rebecca A

Cancer genetics

2017 Volume 218-219, Page(s) 10–14

Abstract: Recurrent chromosomal abnormalities in childhood B-cell acute lymphoblastic leukemia (B-ALL) provide prognostic information that is useful in determining treatment stratification. iAMP21 is a more recently recognized cytogenetic entity of B-ALL that was ... ...

Abstract	Recurrent chromosomal abnormalities in childhood B-cell acute lymphoblastic leukemia (B-ALL) provide prognostic information that is useful in determining treatment stratification. iAMP21 is a more recently recognized cytogenetic entity of B-ALL that was originally described as multiple copies of the RUNX1 gene on a structurally abnormal chromosome 21. Subsequent studies elucidated a common region of highest-level amplification that includes RUNX1. Fluorescence in situ hybridization (FISH) is the most common method used to identify iAMP21, which is defined as the presence of five or more total copies of RUNX1, with three or more extra RUNX1 signals on a single abnormal chromosome 21. More recently, chromosomal microarray (CMA) and next generation sequencing have uncovered a characteristic chromosome 21 copy number profile in cases of iAMP21. We present a case of iAMP21 that does not fit the formal FISH definition. However, CMA uncovered the characteristic chromosome 21 copy number profile that is seen in iAMP21, demonstrating that CMA is helpful for the detection of this entity when FISH results are ambiguous. Furthermore, CMA showed that the highest level of amplification in this case did not include the RUNX1 gene, consistent with current evidence that RUNX1 is not the primary target of amplification.
Language	English
Publishing date	2017-12
Publishing country	United States
Document type	Journal Article
ZDB-ID	2599227-2
ISSN	2210-7762
ISSN	2210-7762
DOI	10.1016/j.cancergen.2017.08.005
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Article: Infectious Complications Following CD19 Chimeric Antigen Receptor T-cell Therapy for Children, Adolescents, and Young Adults.

Vora, Surabhi B / Waghmare, Alpana / Englund, Janet A / Qu, Pingping / Gardner, Rebecca A / Hill, Joshua A

Open forum infectious diseases

2020 Volume 7, Issue 5, Page(s) ofaa121

Abstract: Background: Infectious complications of chimeric antigen receptor (CAR) T-cell immunotherapy in children and young adults have not been well described.: Methods: Medical records of patients ≤26 years old receiving CD19 CAR T-cell infusion (CTI) at a ... ...

Abstract	Background: Infectious complications of chimeric antigen receptor (CAR) T-cell immunotherapy in children and young adults have not been well described. Methods: Medical records of patients ≤26 years old receiving CD19 CAR T-cell infusion (CTI) at a single institution between 2014 and 2017 were reviewed. The number of infections per 100 days-at-risk (infection density) in the 90 days preceding and 0-28 and 29-90 days after CTI was calculated. Poisson regression and Cox analyses were utilized to identify risk factors for infections. Results: Eighty-three patients received CTI during the study period. Most patients (98%) had refractory or relapsed acute lymphoblastic leukemia (ALL). Infections occurred in 54% of patients in the 90 days before CTI (infection density, 1.23) and in 40% of patients in the first 28 days following CTI (infection density, 2.89). Infection density decreased to 0.55 in the 29-90 days post-CTI. Most infections were bacteremias (39%) or respiratory viral infections (43%). Pre-CTI risk factors associated with infection included prior hematopoietic cell transplantation (HCT), immunoglobulin G (IgG) level <400 mg/dL, and lymphodepletion other than cyclophosphamide plus fludarabine; post-CTI risk factors included higher-severity CRS and IgG <400 mg/dL. Conclusions: Infection rates in children and young adults receiving CD19 CAR T-cell therapy increase in the first month and then decline. Understanding types and timing of infections and contributing risk factors may help inform prophylactic and monitoring strategies. Specific attention should be given to patients with prior HCT, severe hypogammaglobulinemia, and severe CRS.
Keywords	covid19
Language	English
Publishing date	2020-04-09
Publishing country	United States
Document type	Journal Article
ZDB-ID	2757767-3
ISSN	2328-8957
ISSN	2328-8957
DOI	10.1093/ofid/ofaa121
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