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1. Intravenous and intracranial GD2-CAR T cells for H3K27M+ diffuse midline gliomas

Author

Monje, Michelle, Mahdi, Jasia, Majzner, Robbie, Yeom, Kristen W., Schultz, Liora M., Richards, Rebecca M., Barsan, Valentin, Song, Kun-Wei, Kamens, Jen, Baggott, Christina, Kunicki, Michael, Rietberg, Skyler P., Lim, Alexandria Sung, Reschke, Agnes, Mavroukakis, Sharon, Egeler, Emily, Moon, Jennifer, Patel, Shabnum, Chinnasamy, Harshini, Erickson, Courtney, Jacobs, Ashley, Duh, Allison K., Tunuguntla, Ramya, Klysz, Dorota Danuta, Fowler, Carley, Green, Sean, Beebe, Barbara, Carr, Casey, Fujimoto, Michelle, Brown, Annie Kathleen, Petersen, Ann-Louise G., McIntyre, Catherine, Siddiqui, Aman, Lepori-Bui, Nadia, Villar, Katlin, Pham, Kymhuynh, Bove, Rachel, Musa, Eric, Reynolds, Warren D., Kuo, Adam, Prabhu, Snehit, Rasmussen, Lindsey, Cornell, Timothy T., Partap, Sonia, Fisher, Paul G., Campen, Cynthia J., Grant, Gerald, Prolo, Laura, Ye, Xiaobu, Sahaf, Bita, Davis, Kara L., Feldman, Steven A., Ramakrishna, Sneha, and Mackall, Crystal

Published
2025
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2. Author Correction: Intravenous and intracranial GD2-CAR T cells for H3K27M+ diffuse midline gliomas

Author

Monje, Michelle, Mahdi, Jasia, Majzner, Robbie, Yeom, Kristen W., Schultz, Liora M., Richards, Rebecca M., Barsan, Valentin, Song, Kun-Wei, Kamens, Jen, Baggott, Christina, Kunicki, Michael, Rietberg, Skyler P., Lim, Alexandria Sung, Reschke, Agnes, Mavroukakis, Sharon, Egeler, Emily, Moon, Jennifer, Patel, Shabnum, Chinnasamy, Harshini, Erickson, Courtney, Jacobs, Ashley, Duh, Allison K., Tunuguntla, Ramya, Klysz, Dorota Danuta, Fowler, Carley, Green, Sean, Beebe, Barbara, Carr, Casey, Fujimoto, Michelle, Brown, Annie Kathleen, Petersen, Ann-Louise G., McIntyre, Catherine, Siddiqui, Aman, Lepori-Bui, Nadia, Villar, Katlin, Pham, Kymhuynh, Bove, Rachel, Musa, Eric, Reynolds, Warren D., Kuo, Adam, Prabhu, Snehit, Rasmussen, Lindsey, Cornell, Timothy T., Partap, Sonia, Fisher, Paul G., Campen, Cynthia J., Grant, Gerald, Prolo, Laura, Ye, Xiaobu, Sahaf, Bita, Davis, Kara L., Feldman, Steven A., Ramakrishna, Sneha, and Mackall, Crystal

Published
2024
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3. CD22 CAR T cells demonstrate high response rates and safety in pediatric and adult B-ALL: Phase 1b results

Author

Schultz, Liora M., Jeyakumar, Nikeshan, Kramer, Anne Marijn, Sahaf, Bita, Srinagesh, Hrishi, Shiraz, Parveen, Agarwal, Neha, Hamilton, Mark, Erickson, Courtney, Jacobs, Ashley, Moon, Jennifer, Baggott, Christina, Arai, Sally, Bharadwaj, Sushma, Johnston, Laura J., Liedtke, Michaela, Lowsky, Robert, Meyer, Everett, Negrin, Robert, Rezvani, Andrew, Shizuru, Judy, Sidana, Surbhi, Egeler, Emily, Mavroukakis, Sharon, Tunuguntla, Ramya, Gkitsas-Long, Nikolaos, Retherford, Aidan, Brown, Annie Kathleen, Gramstrap-Petersen, Anne-Louise, Ibañez, Raquel Martin, Feldman, Steven A., Miklos, David B., Mackall, Crystal L., Davis, Kara L., Frank, Matthew, Ramakrishna, Sneha, and Muffly, Lori

Published
2024
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4. Mediport use as an acceptable standard for CAR T cell infusion.

Author

Eylon, Maya, Prabhu, Snehit, John, Samuel, King, Maxwell, Bhatt, Dhruv, Curran, Kevin, Erickson, Courtney, Karras, Nicole, Phillips, Christine, Satwani, Prakash, Southworth, Erica, Baumeister, Susanne, Talano, Julie-An, MacMillan, Margaret, Rossoff, Jenna, Bonifant, Challice, Myers, Gary, Rouce, Rayne, Toner, Keri, Driscoll, Timothy, Katsanis, Emmanuel, Salzberg, Dana, Capitini, Christian, Pacenta, Holly, Pfeiffer, Thomas, Shah, Niketa, Huynh, Van, Skiles, Jodi, Fraint, Ellen, McNerney, Kevin, Quigg, Troy, Krueger, Joerg, Ligon, John, Fabrizio, Vanessa, Baggott, Christina, Laetsch, Theodore, Schultz, Liora, Hermiston, Michelle, De Oliveira, Satiro, and Schiff, Deborah

Subjects
cancer, chimeric antigen receptor T cell, immune cell engineering, immunotherapy, implanted catheter, mediport
Abstract

INTRODUCTION: Mediport use as a clinical option for the administration of chimeric antigen receptor T cell (CAR T cell) therapy in patients with B-cell malignancies has yet to be standardized. Concern for mediport dislodgement, cell infiltration, and ineffective therapy delivery to systemic circulation has resulted in variable practice with intravenous administration of CAR T cell therapy. With CAR T cell commercialization, it is important to establish practice standards for CAR T cell delivery. We conducted a study to establish usage patterns of mediports in the clinical setting and provide a standard of care recommendation for mediport use as an acceptable form of access for CAR T cell infusions. METHODS: In this retrospective cohort study, data on mediport use and infiltration rate was collected from a survey across 34 medical centers in the Pediatric Real-World CAR Consortium, capturing 504 CAR T cell infusion routes across 489 patients. Data represents the largest, and to our knowledge sole, report on clinical CAR T cell infusion practice patterns since FDA approval and CAR T cell commercialization in 2017. RESULTS: Across 34 sites, all reported tunneled central venous catheters, including Broviac® and Hickman® catheters, as accepted standard venous options for CAR T cell infusion. Use of mediports as a standard clinical practice was reported in 29 of 34 sites (85%). Of 489 evaluable patients with reported route of CAR T cell infusion, 184 patients were infused using mediports, with no reported incidences of CAR T cell infiltration. DISCUSSION/CONCLUSION: Based on current clinical practice, mediports are a commonly utilized form of access for CAR T cell therapy administration. These findings support the safe practice of mediport usage as an accepted standard line option for CAR T cell infusion.

Published
2023

5. The Nature of Informal Educators in Science Centers, Science Museums and Zoos: Case Studies of Personnel, Practices, Programs, Outreach and Organization

Author

Erickson, Courtney

Abstract

Informal Science Centers provide educational experiences for people across the country daily. While the terminology is often similar, there are differences between institutions, often determined by mission, organizational structure, and experience. The purpose of this study was to identify shared experiences and unique characteristics of eight informal science centers around the country. The significance of the study was to add to the understanding of informal science educators' responsibilities, organizational structure, decision-making process, and development. Data for the study was collected using qualitative measures through a researcher-created interview, sent to fifteen institutions, after the recommendation from two well-known informal science researchers. Eight organizations agreed to complete the interview process, which was done utilizing a digital platform. The interviews showed most institutions have similar expectations of their educators and their responsibilities. The data indicated educators have large say in determining programming and outreach direction, often based on interest, resources, and state standards. Additionally, the data showed there were significant differences in how institutions structured their educators organizationally. The results of this study show the need for informal science centers to continue to evaluate data to determine best practices. Some institutions seemed to have more efficiently and effectively determined best practices. There should be a continued emphasis on evaluations, both programmatically and personally, as several sites did not have a formal evaluative process. [The dissertation citations contained here are published with the permission of ProQuest LLC. Further reproduction is prohibited without permission. Copies of dissertations may be obtained by Telephone (800) 1-800-521-0600. Web page: http://www.proquest.com/en-US/products/dissertations/individuals.shtml.]

Published
2021

6. GD2-CAR T cell therapy for H3K27M-mutated diffuse midline gliomas

Author

Majzner, Robbie G., Ramakrishna, Sneha, Yeom, Kristen W., Patel, Shabnum, Chinnasamy, Harshini, Schultz, Liora M., Richards, Rebecca M., Jiang, Li, Barsan, Valentin, Mancusi, Rebecca, Geraghty, Anna C., Good, Zinaida, Mochizuki, Aaron Y., Gillespie, Shawn M., Toland, Angus Martin Shaw, Mahdi, Jasia, Reschke, Agnes, Nie, Esther H., Chau, Isabelle J., Rotiroti, Maria Caterina, Mount, Christopher W., Baggott, Christina, Mavroukakis, Sharon, Egeler, Emily, Moon, Jennifer, Erickson, Courtney, Green, Sean, Kunicki, Michael, Fujimoto, Michelle, Ehlinger, Zach, Reynolds, Warren, Kurra, Sreevidya, Warren, Katherine E., Prabhu, Snehit, Vogel, Hannes, Rasmussen, Lindsey, Cornell, Timothy T., Partap, Sonia, Fisher, Paul G., Campen, Cynthia J., Filbin, Mariella G., Grant, Gerald, Sahaf, Bita, Davis, Kara L., Feldman, Steven A., Mackall, Crystal L., and Monje, Michelle

Published
2022
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7. Intravenous and intracranial GD2-CAR T cells for H3K27M+diffuse midline gliomas

Author

Monje, Michelle, Mahdi, Jasia, Majzner, Robbie, Yeom, Kristen W., Schultz, Liora M., Richards, Rebecca M., Barsan, Valentin, Song, Kun-Wei, Kamens, Jen, Baggott, Christina, Kunicki, Michael, Rietberg, Skyler P., Lim, Alexandria Sung, Reschke, Agnes, Mavroukakis, Sharon, Egeler, Emily, Moon, Jennifer, Patel, Shabnum, Chinnasamy, Harshini, Erickson, Courtney, Jacobs, Ashley, Duh, Allison K., Tunuguntla, Ramya, Klysz, Dorota Danuta, Fowler, Carley, Green, Sean, Beebe, Barbara, Carr, Casey, Fujimoto, Michelle, Brown, Annie Kathleen, Petersen, Ann-Louise G., McIntyre, Catherine, Siddiqui, Aman, Lepori-Bui, Nadia, Villar, Katlin, Pham, Kymhuynh, Bove, Rachel, Musa, Eric, Reynolds, Warren D., Kuo, Adam, Prabhu, Snehit, Rasmussen, Lindsey, Cornell, Timothy T., Partap, Sonia, Fisher, Paul G., Campen, Cynthia J., Grant, Gerald, Prolo, Laura, Ye, Xiaobu, Sahaf, Bita, Davis, Kara L., Feldman, Steven A., Ramakrishna, Sneha, and Mackall, Crystal

Abstract

H3K27M-mutant diffuse midline gliomas (DMGs) express high levels of the disialoganglioside GD2 (ref. 1). Chimeric antigen receptor-modified T cells targeting GD2 (GD2-CART) eradicated DMGs in preclinical models1. Arm A of Phase I trial no. NCT04196413(ref. 2) administered one intravenous (IV) dose of autologous GD2-CART to patients with H3K27M-mutant pontine (DIPG) or spinal DMG (sDMG) at two dose levels (DL1, 1 × 106kg−1; DL2, 3 × 106kg−1) following lymphodepleting chemotherapy. Patients with clinical or imaging benefit were eligible for subsequent intracerebroventricular (ICV) intracranial infusions (10–30 × 106GD2-CART). Primary objectives were manufacturing feasibility, tolerability and the identification of maximally tolerated IV dose. Secondary objectives included preliminary assessments of benefit. Thirteen patients enroled, with 11 receiving IV GD2-CART on study (n= 3 DL1 (3 DIPG); n= 8 DL2 (6 DIPG, 2 sDMG)). GD2-CART manufacture was successful for all patients. No dose-limiting toxicities occurred on DL1, but three patients experienced dose-limiting cytokine release syndrome on DL2, establishing DL1 as the maximally tolerated IV dose. Nine patients received ICV infusions, with no dose-limiting toxicities. All patients exhibited tumour inflammation-associated neurotoxicity, safely managed with intensive monitoring and care. Four patients demonstrated major volumetric tumour reductions (52, 54, 91 and 100%), with a further three patients exhibiting smaller reductions. One patient exhibited a complete response ongoing for over 30 months since enrolment. Nine patients demonstrated neurological benefit, as measured by a protocol-directed clinical improvement score. Sequential IV, followed by ICV GD2-CART, induced tumour regressions and neurological improvements in patients with DIPG and those with sDMG.

Published
2025
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8. Case report: sub-clinical extramedullary B-ALL in the setting of relapse following targeted therapy.

Author

Johns, Claire, Erickson, Courtney, Jacobs, Ashley, Moon, Jennifer, Baggott, Christina, Dagher, Regina, Nadel, Helen, Balagtas, Jay, Aftandilian, Catherine, Ramakrishna, Sneha, Lacayo, Norman, Davis, Kara L., Stieglitz, Elliot, and Schultz, Liora

Subjects
BONE marrow examination, EXTRAMEDULLARY diseases, LYMPHOBLASTIC leukemia, CHIMERIC antigen receptors, CEREBROSPINAL fluid
Abstract

Standard testing for disease evaluation in B-cell acute lymphoblastic leukemia (B-ALL) includes examination of the bone marrow and cerebrospinal fluid. Radiographic or functional imaging are indicated when clinical signs of non-CNS extramedullary disease are present but are not standard in the relapsed/refractory setting. We describe two cases of patients with relapsed/refractory BALL with prior exposure to blinatumomab and/or inotuzumab ozogamicin presenting for CAR-T cell treatment. Both patients were thought to only have minimal residual disease (MRD) at the pre-CAR disease assessment, with MRD of 6,648 (0.66%) and 100 (0.01%) cells per million cells, respectively, as measured by next-generation sequencing (NGS) in their bone marrows. Both patients for distinct reasons unrelated to non-CNS extra-medullary (EM) symptoms had PETMRIs prior to lymphodepletion and CAR T cell infusion. In both cases patients were found to have significant bulky subclinical EM disease that required changes in clinical management. In the newly-emergent era of antigen-targeted immunotherapy, it is foundational that incidence and relapse patterns following targeted therapy are well-understood. Herein we contribute to a growing body of literature addressing this fundamental clinical gap and highlight a future role for formal prospective imaging studies to better establish response, toxicity and relapse patterns following CAR-T cell therapy in EM B-ALL. [ABSTRACT FROM AUTHOR]

Published
2024
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9. Mediport use as an acceptable standard for CAR T cell infusion

Author

Eylon, Maya, primary, Prabhu, Snehit, additional, John, Samuel, additional, King, Maxwell J. M., additional, Bhatt, Dhruv, additional, Curran, Kevin J., additional, Erickson, Courtney, additional, Karras, Nicole A., additional, Phillips, Christine L., additional, Satwani, Prakash, additional, Hermiston, Michelle, additional, Southworth, Erica, additional, Baumeister, Susanne H. C., additional, Talano, Julie-An, additional, MacMillan, Margaret L., additional, Rossoff, Jenna, additional, Bonifant, Challice L., additional, Myers, Gary Doug, additional, Rouce, Rayne H., additional, Toner, Keri, additional, Driscoll, Timothy A., additional, Katsanis, Emmanuel, additional, Salzberg, Dana B., additional, Schiff, Deborah, additional, De Oliveira, Satiro N., additional, Capitini, Christian M., additional, Pacenta, Holly L., additional, Pfeiffer, Thomas, additional, Shah, Niketa C., additional, Huynh, Van, additional, Skiles, Jodi L., additional, Fraint, Ellen, additional, McNerney, Kevin O., additional, Quigg, Troy C., additional, Krueger, Joerg, additional, Ligon, John A., additional, Fabrizio, Vanessa A., additional, Baggott, Christina, additional, Laetsch, Theodore W., additional, and Schultz, Liora M., additional

Published
2023
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10. Abstract 959: Immune signatures of GD2 CAR T cell activity in H3K27M+ diffuse midline glioma patients

Author

Ramakrishna, Sneha, primary, Good, Zinaida, additional, Desai, Moksha, additional, Zamler, Daniel, additional, Mancusi, Rebecca, additional, Mahdi, Jasia, additional, Majzner, Robbie, additional, Schultz, Liora, additional, Richards, Rebecca, additional, Kamens, Jennifer, additional, Barsan, Valentin, additional, Campen, Cynthia, additional, Partap, Sonia, additional, Ehlinger, Zachary, additional, Reynolds, Warren, additional, Chen, Yiyun, additional, Hamilton, Mark P., additional, Moon, Jennifer, additional, Baggott, Christina, additional, Kunicki, Michael, additional, Fujimoto, Michelle, additional, Li, Amy, additional, Jariwala, Sneha, additional, Mavroukakis, Sharon, additional, Egeler, Emily, additional, Jacobs, Ashley, additional, Erickson, Courtney, additional, Yamabe-Kwong, Karen, additional, Prabhu, Snehit, additional, Davis, Kara, additional, Feldman, Steve, additional, Sahaf, Bita, additional, Mackall, Crystal L., additional, and Monje, Michelle, additional

Published
2023
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11. Role of peripheral blood MRD and 18F-FDG PET in the post-CAR relapse setting: a case study of discordant peripheral blood and bone marrow MRD

Author

Schultz, Liora, primary, Davis, Kara Lynn, additional, Walkush, Ann, additional, Baggott, Christina, additional, Erickson, Courtney, additional, Ramakrishna, Sneha, additional, Aftandilian, Catherine, additional, Lacayo, Norman, additional, Nadel, Helen Ruth, additional, Oak, Jean, additional, and Mackall, Crystal L, additional

Published
2023
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12. Long-Term Follow-up of CD19/22 CAR Therapy in Children and Young Adults with B-ALL Reveals Efficacy, Tolerability and High Survival Rates When Coupled with Hematopoietic Stem Cell Transplantation

Author

Schultz, Liora M., primary, Ramakrishna, Sneha, additional, Baskar, Reema, additional, Richards, Rebecca M, additional, Moon, Jennifer, additional, Baggott, Christina, additional, Fujimoto, Michelle, additional, Kunicki, Michael, additional, Li, Amy, additional, Jariwala, Sneha, additional, Erickson, Courtney, additional, Jacobs, Ashley, additional, Yamabe, Karen, additional, Barsan, Valentin, additional, Majzner, Robbie G., additional, Egeler, Emily L., additional, Mavroukakis, Sharon, additional, Ehlinger, Zachary, additional, Reynolds, Warren D., additional, Sahaf, Bita, additional, Muffly, Lori, additional, Frank, Matthew J, additional, Gramstrup, Anne-Louise, additional, Chinnasamy, Harshini, additional, Patel, Shabnum, additional, Miklos, David B., additional, Feldman, Steven A., additional, Mackall, Crystal L., additional, and Davis, Kara L., additional

Published
2022
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13. Abstract CT031: GD2 CAR T cells mediate clinical activity and manageable toxicity in children and young adults with DIPG and H3K27M-mutated diffuse midline gliomas

Author

Majzner, Robbie G., primary, Ramakrishna, Sneha, additional, Mochizuki, Aaron, additional, Patel, Shabnum, additional, Chinnasamy, Harshini, additional, Yeom, Kristen, additional, Schultz, Liora, additional, Richards, Rebecca, additional, Campen, Cynthia, additional, Reschke, Agnes, additional, Mahdi, Jasia, additional, Toland, Angus Martin Shaw, additional, Baggott, Christina, additional, Mavroukakis, Sharon, additional, Egeler, Emily, additional, Moon, Jennifer, additional, Landrum, Kayla, additional, Erickson, Courtney, additional, Rasmussen, Lindsey, additional, Barsan, Valentin, additional, Tamaresis, John S., additional, Marcy, Anne Cunniffe, additional, Kunicki, Michael, additional, Fujimoto, Michelle, additional, Ehlinger, Zach, additional, Kurra, Sreevidya, additional, Cornell, Timothy, additional, Partap, Sonia, additional, Fisher, Paul, additional, Grant, Gerald, additional, Vogel, Hannes, additional, Sahaf, Bita, additional, Davis, Kara, additional, Feldman, Steven, additional, Mackall, Crystal L., additional, and Monje, Michelle, additional

Published
2021
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14. OMIC-11. SINGLE CELL RNA SEQUENCING FROM THE CSF OF SUBJECTS WITH H3K27M+ DIPG/DMG TREATED WITH GD2 CAR T-CELLULAR THERAPY

Author

Mochizuki, Aaron, primary, Ramakrishna, Sneha, additional, Good, Zina, additional, Patel, Shabnum, additional, Chinnasamy, Harshini, additional, Yeom, Kristen, additional, Schultz, Liora, additional, Richards, Rebecca, additional, Campen, Cynthia, additional, Reschke, Agnes, additional, Mahdi, Jasia, additional, Toland, Angus, additional, Baggot, Christina, additional, Mavroukakis, Sharon, additional, Egeler, Emily, additional, Moon, Jennifer, additional, Landrum, Kayla, additional, Erickson, Courtney, additional, Rasmussen, Lindsey, additional, Barsan, Valentin, additional, Tamaresis, John, additional, Marcy, Anne, additional, Kunicki, Michael, additional, Celones, Michelle, additional, Ehlinger, Zach, additional, Kurra, Sreevidya, additional, Cornell, Timothy, additional, Partap, Sonia, additional, Fisher, Paul, additional, Grant, Gerald, additional, Vogel, Hannes, additional, Davis, Kara, additional, Feldman, Steven, additional, Sahaf, Bita, additional, Majzner, Robbie, additional, Mackall, Crystal, additional, and Monje, Michelle, additional

Published
2021
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15. EPCT-14. GD2 CAR T-CELLS MEDIATE CLINICAL ACTIVITY AND MANAGEABLE TOXICITY IN CHILDREN AND YOUNG ADULTS WITH H3K27M-MUTATED DIPG AND SPINAL CORD DMG

Author

Majzner, Robbie, primary, Ramakrishna, Sneha, additional, Mochizuki, Aaron, additional, Patel, Shabnum, additional, Chinnasamy, Harshini, additional, Yeom, Kristen, additional, Schultz, Liora, additional, Richards, Rebecca, additional, Campen, Cynthia, additional, Reschke, Agnes, additional, Mahdi, Jasia, additional, Toland, Angus Martin Shaw, additional, Baggott, Christina, additional, Mavroukakis, Sharon, additional, Egeler, Emily, additional, Moon, Jennifer, additional, Landrum, Kayla, additional, Erickson, Courtney, additional, Rasmussen, Lindsay, additional, Barsan, Valentin, additional, Tamaresis, John, additional, Marcy, Anne, additional, Kunicki, Michael, additional, Fujimoto, Michelle, additional, Ehlinger, Zach, additional, Kurra, Sreevidya, additional, Cornell, Timothy, additional, Partap, Sonia, additional, Fisher, Paul, additional, Grant, Gerald, additional, Vogel, Hannes, additional, Sahaf, Bita, additional, Davis, Kara, additional, Feldman, Steven, additional, Mackall, Crystal, additional, and Monje, Michelle, additional

Published
2021
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16. Author Correction: Intravenous and intracranial GD2-CAR T cells for H3K27M+diffuse midline gliomas

Author

Monje, Michelle, Mahdi, Jasia, Majzner, Robbie, Yeom, Kristen W., Schultz, Liora M., Richards, Rebecca M., Barsan, Valentin, Song, Kun-Wei, Kamens, Jen, Baggott, Christina, Kunicki, Michael, Rietberg, Skyler P., Lim, Alexandria Sung, Reschke, Agnes, Mavroukakis, Sharon, Egeler, Emily, Moon, Jennifer, Patel, Shabnum, Chinnasamy, Harshini, Erickson, Courtney, Jacobs, Ashley, Duh, Allison K., Tunuguntla, Ramya, Klysz, Dorota Danuta, Fowler, Carley, Green, Sean, Beebe, Barbara, Carr, Casey, Fujimoto, Michelle, Brown, Annie Kathleen, Petersen, Ann-Louise G., McIntyre, Catherine, Siddiqui, Aman, Lepori-Bui, Nadia, Villar, Katlin, Pham, Kymhuynh, Bove, Rachel, Musa, Eric, Reynolds, Warren D., Kuo, Adam, Prabhu, Snehit, Rasmussen, Lindsey, Cornell, Timothy T., Partap, Sonia, Fisher, Paul G., Campen, Cynthia J., Grant, Gerald, Prolo, Laura, Ye, Xiaobu, Sahaf, Bita, Davis, Kara L., Feldman, Steven A., Ramakrishna, Sneha, and Mackall, Crystal

Published
2024
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17. Identification of dual positive CD19+/CD3+ T cells in a leukapheresis product undergoing CAR transduction: a case report

Author

Schultz, Liora, primary, Patel, Shabnum, additional, Davis, Kara Lynn, additional, Ramakrishna, Sneha, additional, Sahaf, Bita, additional, Bhatia, Neehar, additional, Baggott, Christina, additional, Erickson, Courtney, additional, Majzner, Robbie G, additional, Oak, Jean, additional, Bertaina, Alice, additional, Mackall, Crystal, additional, and Feldman, Steven, additional

Published
2020
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18. Phase I Trial Using CD19/CD22 Bispecific CAR T Cells in Pediatric and Adult Acute Lymphoblastic Leukemia (ALL)

Author

Schultz, Liora M, primary, Muffly, Lori S, primary, Spiegel, Jay Y., primary, Ramakrishna, Sneha, primary, Hossain, Nasheed, primary, Baggott, Christina, primary, Sahaf, Bita, primary, Patel, Shabnum, primary, Craig, Juliana, primary, Yoon, Jenny, primary, Kadapakkam, Meena, primary, Majzner, Robbie G., primary, Frank, Matthew J., primary, Erickson, Courtney, primary, Marcy, Anne Cunniffe, primary, Fujimoto, Michelle, primary, Bhatia, Neehar, primary, Meyer, Everett H, primary, Kong, Katherine A., primary, Egeler, Emily, primary, Mavroukakis, Sharon, primary, Qin, Haiying, primary, Fry, Terry J., primary, Feldman, Steven A, primary, Miklos, David B, primary, Mackall, Crystal L., primary, and Davis, Kara L., primary

Published
2019
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19. Tales from Abroad -- Courtney Erickson

Author

Erickson, Courtney

Subjects
News, opinion and commentary, Sports and fitness
Abstract

Byline: Courtney Erickson Our journey started with a 14 hour flight from Chicago to Beijing. We landed at night and since Beijing is home to almost 22 million people, it [...]

Published
2018

22. Sequential intravenous and intracerebroventricular GD2-CAR T-cell therapy for H3K27M-mutated diffuse midline gliomas.

Author

Monje M, Mahdi J, Majzner R, Yeom K, Schultz LM, Richards RM, Barsan V, Song KW, Kamens J, Baggott C, Kunicki M, Lim AS, Reschke A, Mavroukakis S, Egeler E, Moon J, Patel S, Chinnasamy H, Erickson C, Jacobs A, Duh AK, Rietberg SP, Tunuguntla R, Klysz DD, Fowler C, Green S, Beebe B, Carr C, Fujimoto M, Brown AK, Petersen AG, McIntyre C, Siddiqui A, Lepori-Bui N, Villar K, Pham K, Bove R, Musa E, Reynolds W, Kuo A, Prabhu S, Rasmussen L, Cornell TT, Partap S, Fisher PG, Campen CJ, Grant G, Prolo L, Ye X, Sahaf B, Davis KL, Feldman SA, Ramakrishna S, and Mackall C

Abstract

H3K27M-mutant diffuse midline gliomas (DMGs) express high levels of the GD2 disialoganglioside and chimeric antigen receptor modified T-cells targeting GD2 (GD2-CART) eradicate DMGs in preclinical models. Arm A of the Phase I trial NCT04196413 administered one IV dose of autologous GD2-CART to patients with H3K27M-mutant pontine (DIPG) or spinal (sDMG) diffuse midline glioma at two dose levels (DL1=1e6/kg; DL2=3e6/kg) following lymphodepleting (LD) chemotherapy. Patients with clinical or imaging benefit were eligible for subsequent intracerebroventricular (ICV) GD2-CART infusions (10-30e6 GD2-CART). Primary objectives were manufacturing feasibility, tolerability, and identification of a maximally tolerated dose of IV GD2-CART. Secondary objectives included preliminary assessments of benefit. Thirteen patients enrolled and 11 received IV GD2-CART on study [n=3 DL1(3 DIPG); n=8 DL2(6 DIPG/2 sDMG). GD2-CART manufacturing was successful for all patients. No dose-limiting toxicities (DLTs) occurred on DL1, but three patients experienced DLT on DL2 due to grade 4 cytokine release syndrome (CRS). Nine patients received ICV infusions, which were not associated with DLTs. All patients exhibited tumor inflammation-associated neurotoxicity (TIAN). Four patients demonstrated major volumetric tumor reductions (52%, 54%, 91% and 100%). One patient exhibited a complete response ongoing for >30 months since enrollment. Eight patients demonstrated neurological benefit based upon a protocol-directed Clinical Improvement Score. Sequential IV followed by ICV GD2-CART induced tumor regressions and neurological improvements in patients with DIPG and sDMG. DL1 was established as the maximally tolerated IV GD2-CART dose. Neurotoxicity was safely managed with intensive monitoring and close adherence to a management algorithm.

Published
2024
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