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Article ; Online: Ethical Considerations in Pediatric Stem Cell Donation.

Grilley, Bambi J

Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation

2016 Volume 22, Issue 1, Page(s) 3

MeSH term(s)	Child ; Humans ; Stem Cells ; Tissue and Organ Procurement
Language	English
Publishing date	2016-01
Publishing country	United States
Document type	Comment ; Journal Article
ZDB-ID	1474865-4
ISSN	1523-6536 ; 1083-8791
ISSN (online)	1523-6536
ISSN	1083-8791
DOI	10.1016/j.bbmt.2015.11.005
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Article: Eighteen-year survival after GD2-directed Chimeric Antigen Receptor-Modified Immune Effector Cell Treatment for Neuroblastoma.

Che-Hsing, Li / Sharma, Sandhya / Heczey, Andras A / Steffin, David H M / Louis, Chrystal U / Grilley, Bambi J / Thakkar, Sachin G / Wu, Mengfen / Wang, Tao / Rooney, Cliona M / Brenner, Malcolm K / Heslop, Helen E

Research square

2024

Abstract: We report long-term outcomes up to 18 years of a clinical trial treating children with neuroblastoma with EBV-specific T lymphocytes and CD3-activated T cells - each expressing a first-generation chimeric antigen receptor targeting GD2 with barcoded ... ...

Abstract	We report long-term outcomes up to 18 years of a clinical trial treating children with neuroblastoma with EBV-specific T lymphocytes and CD3-activated T cells - each expressing a first-generation chimeric antigen receptor targeting GD2 with barcoded transgenes to allow tracking of each population. Of 11 patients with active disease at infusion, three patients achieved a complete response that was sustained in 2, one for 8 years until lost to follow up and one for 18+ years. Of eight patients with a history of relapse or at high risk of recurrence, five are disease-free at their last follow-up between 10-14 years post-infusion. Intermittent low levels of transgene were detected during the follow up period with significantly greater persistence in those who were long-term survivors. In conclusion, patients with relapsed/refractory neuroblastoma achieved long-term disease control after receiving GD2 CAR-T cell therapy including one patient now in remission of relapsed disease for >18 years.
Language	English
Publishing date	2024-04-11
Publishing country	United States
Document type	Preprint
DOI	10.21203/rs.3.rs-4232549/v1
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Article ; Online: Incipient clonal hematopoiesis is accelerated following CD30.CAR-T therapy.

Kapadia, Chiraag D / Rosas, Gerardo / Thakkar, Sachin G / Wu, Mengfen / Torrano, Virginia / Wang, Tao / Grilley, Bambi J / Heslop, Helen E / Ramos, Carlos A / Goodell, Margaret A / Lulla, Premal D

Cytotherapy

2023 Volume 26, Issue 3, Page(s) 261–265

Abstract: Chimeric antigen receptor (CAR) T-cells are an emerging therapy for refractory lymphomas. Clonal hematopoiesis (CH), the preferential outgrowth of mutated bone marrow progenitors, is enriched in lymphoma patients receiving CAR-T cells. CAR-T therapy ... ...

Abstract	Chimeric antigen receptor (CAR) T-cells are an emerging therapy for refractory lymphomas. Clonal hematopoiesis (CH), the preferential outgrowth of mutated bone marrow progenitors, is enriched in lymphoma patients receiving CAR-T cells. CAR-T therapy requires conditioning chemotherapy and often induces systemic inflammatory reactions, both of which have been shown to promote expansion of CH clones. Thus, we hypothesized that pre-existing CH clones could expand during CAR-T cell treatment. We measured CH at 154 timepoints longitudinally sampled from 26 patients receiving CD30.CAR-T therapy for CD30+ lymphomas on an investigational protocol (NCT02917083). Pre-treatment CH was present in 54% of individuals and did not correlate with survival outcomes or inflammatory toxicities. Longitudinal tracking of single clones in individual patients revealed distinct clone growth dynamics. Initially small clones, defined as VAF <1%, expanded following CAR-T administration, compared with relatively muted expansions of larger clones (3.37-fold vs. 1.20-fold, P = 0.0014). Matched clones were present at low magnitude in the infused CD30.CAR-T product for all CH cases but did not affect the product's immunophenotype or transduction efficiency. As cellular immunotherapies expand to become frontline treatments for hematological malignancies, our data indicates CAR-T recipients could be enriched for CH, and further longitudinal studies centered on CH complications in this population are warranted.
MeSH term(s)	Humans ; Receptors, Chimeric Antigen ; Clonal Hematopoiesis ; Immunotherapy, Adoptive/adverse effects ; Immunotherapy, Adoptive/methods ; Lymphoma/therapy ; Immunotherapy ; Hematopoiesis/genetics
Chemical Substances	Receptors, Chimeric Antigen
Language	English
Publishing date	2023-12-26
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.2023.11.013
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Article ; Online: Ultralow-dose binary oncolytic/helper-dependent adenovirus promotes antitumor activity in preclinical and clinical studies.

Wang, Daniel / Porter, Caroline E / Lim, Bora / Rosewell Shaw, Amanda / Robertson, Catherine S / Woods, Mae L / Xu, Ya / Biegert, Greyson G W / Morita, Daisuke / Wang, Tao / Grilley, Bambi J / Heslop, Helen / Brenner, Malcolm K / Suzuki, Masataka

Science advances

2023 Volume 9, Issue 13, Page(s) eade6790

Abstract: We show that a binary oncolytic/helper-dependent adenovirus (CAdVEC) that both lyses tumor cells and locally expresses the proinflammatory cytokine IL-12 and PD-L1 blocking antibody has potent antitumor activity in humanized mouse models. On the basis of ...

Abstract	We show that a binary oncolytic/helper-dependent adenovirus (CAdVEC) that both lyses tumor cells and locally expresses the proinflammatory cytokine IL-12 and PD-L1 blocking antibody has potent antitumor activity in humanized mouse models. On the basis of these preclinical studies, we treated four patients with a single intratumoral injection of an ultralow dose of CAdVEC (NCT03740256), representing a dose of oncolytic adenovirus more than 100-fold lower than used in previous trials. While CAdVEC caused no significant toxicities, it repolarized the tumor microenvironment with increased infiltration of CD8 T cells. A single administration of CAdVEC was associated with both locoregional and abscopal effects on metastases and, in combination with systemic administration of immune checkpoint antibodies, induced sustained antitumor responses, including one complete and two partial responses. Hence, in both preclinical and clinical studies, CAdVEC is safe and even at extremely low doses is sufficiently potent to induce significant tumor control through oncolysis and immune repolarization.
MeSH term(s)	Mice ; Animals ; Oncolytic Virotherapy/adverse effects ; Oncolytic Viruses ; Adenoviridae/genetics ; Neoplasms/pathology ; Cytokines ; Cell Line, Tumor ; Tumor Microenvironment
Chemical Substances	Cytokines
Language	English
Publishing date	2023-03-29
Publishing country	United States
Document type	Journal Article
ZDB-ID	2810933-8
ISSN	2375-2548 ; 2375-2548
ISSN (online)	2375-2548
ISSN	2375-2548
DOI	10.1126/sciadv.ade6790
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Article ; Online: Allogeneic, off-the-shelf, SARS-CoV-2-specific T cells (ALVR109) for the treatment of COVID-19 in high-risk patients.

Vasileiou, Spyridoula / Hill, LaQuisa / Kuvalekar, Manik / Workineh, Aster G / Watanabe, Ayumi / Velazquez, Yovana / Lulla, Suhasini / Mooney, Kimberly / Lapteva, Natalia / Grilley, Bambi J / Heslop, Helen E / Rooney, Cliona M / Brenner, Malcolm K / Eagar, Todd N / Carrum, George / Grimes, Kevin A / Leen, Ann M / Lulla, Premal

Haematologica

2023 Volume 108, Issue 7, Page(s) 1840–1850

Abstract: Defects in T-cell immunity to SARS-CoV-2 have been linked to an increased risk of severe COVID-19 (even after vaccination), persistent viral shedding and the emergence of more virulent viral variants. To address this T-cell deficit, we sought to prepare ... ...

Abstract	Defects in T-cell immunity to SARS-CoV-2 have been linked to an increased risk of severe COVID-19 (even after vaccination), persistent viral shedding and the emergence of more virulent viral variants. To address this T-cell deficit, we sought to prepare and cryopreserve banks of virus-specific T cells, which would be available as a partially HLA-matched, off-the-shelf product for immediate therapeutic use. By interrogating the peripheral blood of healthy convalescent donors, we identified immunodominant and protective T-cell target antigens, and generated and characterized polyclonal virus-specific T-cell lines with activity against multiple clinically important SARS-CoV-2 variants (including 'delta' and 'omicron'). The feasibility of making and safely utilizing such virus-specific T cells clinically was assessed by administering partially HLA-matched, third-party, cryopreserved SARS-CoV-2-specific T cells (ALVR109) in combination with other antiviral agents to four individuals who were hospitalized with COVID-19. This study establishes the feasibility of preparing and delivering off-the-shelf, SARS-CoV-2-directed, virus-specific T cells to patients with COVID-19 and supports the clinical use of these products outside of the profoundly immune compromised setting (ClinicalTrials.gov number, NCT04401410).
MeSH term(s)	Humans ; COVID-19 ; Hematopoietic Stem Cell Transplantation ; Lymphocytes ; SARS-CoV-2
Language	English
Publishing date	2023-07-01
Publishing country	Italy
Document type	Clinical Trial ; Journal Article
ZDB-ID	2333-4
ISSN	1592-8721 ; 0017-6567 ; 0390-6078
ISSN (online)	1592-8721
ISSN	0017-6567 ; 0390-6078
DOI	10.3324/haematol.2022.281946
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Article ; Online: International Society for Cell & Gene Therapy Position Paper: Key considerations to support evidence-based cell and gene therapies and oppose marketing of unproven products.

Ikonomou, Laertis / Cuende, Natividad / Forte, Miguel / Grilley, Bambi J / Levine, Aaron D / Munsie, Megan / Rasko, John E J / Turner, Leigh / Bidkhori, Hamid R / Ciccocioppo, Rachele / Grignon, Felix / Srivastava, Alok / Weiss, Daniel J / Zettler, Patricia / Levine, Bruce L

Cytotherapy

2023 Volume 25, Issue 9, Page(s) 920–929

Abstract: The field of regenerative medicine, including cellular immunotherapies, is on a remarkable growth trajectory. Dozens of cell-, tissue- and gene-based products have received marketing authorization worldwide while hundreds-to-thousands are either in ... ...

Abstract	The field of regenerative medicine, including cellular immunotherapies, is on a remarkable growth trajectory. Dozens of cell-, tissue- and gene-based products have received marketing authorization worldwide while hundreds-to-thousands are either in preclinical development or under clinical investigation in phased clinical trials. However, the promise of regenerative therapies has also given rise to a global industry of direct-to-consumer offerings of prematurely commercialized cell and cell-based products with unknown safety and efficacy profiles. Since its inception, the International Society for Cell & Gene Therapy Committee on the Ethics of Cell and Gene Therapy has opposed the premature commercialization of unproven cell- and gene-based interventions and supported the development of evidence-based advanced therapy products. In the present Guide, targeted at International Society for Cell & Gene Therapy members, we analyze this industry, focusing in particular on distinctive features of unproven cell and cell-based products and the use of tokens of scientific legitimacy as persuasive marketing devices. We also provide an overview of reporting mechanisms for patients who believe they have been harmed by administration of unapproved and unproven products and suggest practical strategies to address the direct-to-consumer marketing of such products. Development of this Guide epitomizes our continued support for the ethical and rigorous development of cell and cell-based products with patient safety and therapeutic benefit as guiding principles.
MeSH term(s)	Humans ; Cell- and Tissue-Based Therapy ; Marketing ; Regenerative Medicine ; Genetic Therapy
Language	English
Publishing date	2023-06-26
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.2023.03.002
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Article: Interleukin-15-armored GPC3-CAR T cells for patients with solid cancers.

Steffin, David / Ghatwai, Nisha / Montalbano, Antonino / Rathi, Purva / Courtney, Amy N / Arnett, Azlann B / Fleurence, Julien / Sweidan, Ramy / Wang, Thao / Zhang, Huimin / Masand, Prakash / Maris, John M / Martinez, Daniel / Pogoriler, Jennifer / Varadarajan, Navin / Thakkar, Sachin G / Lyon, Deborah / Lapteva, Natasha / Mei, Zhuyong /

Patel, Kalyani / Lopez-Terrada, Dolores / Ramos, Carlos / Lulla, Premal / Armaghany, Tannaz / Grilley, Bambi J / Dotti, Gianpietro / Metelitsa, Leonid S / Heslop, Helen E / Brenner, Malcolm K / Sumazin, Pavel / Heczey, Andras

Research square

2024

Abstract: Interleukin-15 (IL15) promotes the survival of T lymphocytes and enhances the antitumor properties of CAR T cells in preclinical models of solid neoplasms in which CAR T cells have limited ... ...

Abstract	Interleukin-15 (IL15) promotes the survival of T lymphocytes and enhances the antitumor properties of CAR T cells in preclinical models of solid neoplasms in which CAR T cells have limited efficacy
Language	English
Publishing date	2024-04-03
Publishing country	United States
Document type	Preprint
DOI	10.21203/rs.3.rs-4103623/v1
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Article ; Online: Long-term follow-up for the development of subsequent malignancies in patients treated with genetically modified IECs.

Steffin, David H M / Muhsen, Ibrahim N / Hill, LaQuisa C / Ramos, Carlos A / Ahmed, Nabil / Hegde, Meenakshi / Wang, Tao / Wu, Mengfen / Gottschalk, Stephen / Whittle, Sarah B / Lulla, Premal D / Mamonkin, Maksim / Omer, Bilal / Rouce, Rayne H / Heczey, Andras / Metelitsa, Leonid S / Grilley, Bambi J / Robertson, Catherine / Torrano, Virginia /

Lapteva, Natalia / Gee, Adrian P / Rooney, Cliona M / Brenner, Malcolm K / Heslop, Helen E

Blood

2022 Volume 140, Issue 1, Page(s) 16–24

Abstract: Subsequent malignancies are well-documented complications in long-term follow-up of cancer patients. Recently, genetically modified immune effector (IE) cells have shown benefit in hematologic malignancies and are being evaluated in clinical trials for ... ...

Abstract	Subsequent malignancies are well-documented complications in long-term follow-up of cancer patients. Recently, genetically modified immune effector (IE) cells have shown benefit in hematologic malignancies and are being evaluated in clinical trials for solid tumors. Although the short-term complications of IE cells are well described, there is limited literature summarizing long-term follow-up, including subsequent malignancies. We retrospectively reviewed data from 340 patients treated across 27 investigator-initiated pediatric and adult clinical trials at our center. All patients received IE cells genetically modified with γ-retroviral vectors to treat relapsed and/or refractory hematologic or solid malignancies. In a cumulative 1027 years of long-term follow-up, 13 patients (3.8%) developed another cancer with a total of 16 events (4 hematologic malignancies and 12 solid tumors). The 5-year cumulative incidence of a first subsequent malignancy in the recipients of genetically modified IE cells was 3.6% (95% confidence interval, 1.8% to 6.4%). For 11 of the 16 subsequent tumors, biopsies were available, and no sample was transgene positive by polymerase chain reaction. Replication-competent retrovirus testing of peripheral blood mononuclear cells was negative in the 13 patients with subsequent malignancies tested. Rates of subsequent malignancy were low and comparable to standard chemotherapy. These results suggest that the administration of IE cells genetically modified with γ retroviral vectors does not increase the risk for subsequent malignancy.
MeSH term(s)	Adult ; Child ; Follow-Up Studies ; Hematologic Neoplasms/genetics ; Hematologic Neoplasms/therapy ; Humans ; Leukocytes, Mononuclear ; Neoplasms/genetics ; Neoplasms/therapy ; Retrospective Studies
Language	English
Publishing date	2022-03-03
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	80069-7
ISSN	1528-0020 ; 0006-4971
ISSN (online)	1528-0020
ISSN	0006-4971
DOI	10.1182/blood.2022015728
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Article ; Online: T-Cell Therapy for Lymphoma Using Nonengineered Multiantigen-Targeted T Cells Is Safe and Produces Durable Clinical Effects.

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

2021 Volume 39, Issue 13, Page(s) 1415–1425

Abstract: Purpose: Patients with relapsed lymphomas often fail salvage therapies including high-dose chemotherapy and mono-antigen-specific T-cell therapies, highlighting the need for nontoxic, novel treatments. To that end, we clinically tested an autologous T- ... ...

Abstract	Purpose: Patients with relapsed lymphomas often fail salvage therapies including high-dose chemotherapy and mono-antigen-specific T-cell therapies, highlighting the need for nontoxic, novel treatments. To that end, we clinically tested an autologous T-cell product that targets multiple tumor-associated antigens (TAAs) expressed by lymphomas with the intent of treating disease and preventing immune escape. Patients and methods: We expanded polyclonal T cells reactive to five TAAs: PRAME, SSX2, MAGEA4, SURVIVIN, and NY-ESO-1. Products were administered to 32 patients with Hodgkin lymphomas (n = 14) or non-Hodgkin lymphomas (n = 18) in a two-part phase I clinical trial, where the objective of the first phase was to establish the safety of targeting all five TAAs (fixed dose, 0.5 × 10 Results: Infusions were safe with no dose-limiting toxicities observed in either the antigen- or dose-escalation phases. Although the maximum tolerated dose was not reached, the maximum tested dose at which efficacy was observed (two infusions, 2 × 10 Conclusion: T cells targeting five TAAs and administered at doses of up to two infusions of 2 × 10
MeSH term(s)	Adolescent ; Adult ; Aged ; Antigens, Neoplasm/immunology ; Cell- and Tissue-Based Therapy/methods ; Female ; Humans ; Lymphoma/immunology ; Lymphoma/therapy ; Male ; Middle Aged ; Prognosis ; Salvage Therapy ; T-Lymphocytes/transplantation ; Young Adult
Chemical Substances	Antigens, Neoplasm
Language	English
Publishing date	2021-01-28
Publishing country	United States
Document type	Clinical Trial, Phase I ; Journal Article ; Multicenter Study ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	604914-x
ISSN	1527-7755 ; 0732-183X
ISSN (online)	1527-7755
ISSN	0732-183X
DOI	10.1200/JCO.20.02224
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Zs.MO 650: Show issues

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Article: Gaining access to investigational drugs for treatment: an investigational new drug application primer.

Kramer, Mark A / Grilley, Bambi J

International journal of pharmaceutical compounding

2002 Volume 6, Issue 4, Page(s) 271–273

Language	English
Publishing date	2002-07
Publishing country	United States
Document type	Journal Article
ISSN	1092-4221
ISSN	1092-4221
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