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Chiara F. Magnani, … , Alessandro Rambaldi, Andrea Biondi
Published August 11, 2020
Citation Information: J Clin Invest. 2020;130(11):6021-6033. https://doi.org/10.1172/JCI138473.
Citation Information: J Clin Invest. 2020;130(11):6021-6033. https://doi.org/10.1172/JCI138473.
Abstract
BACKGROUND Chimeric antigen receptor (CAR) T cell immunotherapy has resulted in complete remission (CR) and durable response in highly refractory patients. However, logistical complexity and high costs of manufacturing autologous viral products limit CAR T cell availability.METHODS We report the early results of a phase I/II trial in B cell acute lymphoblastic leukemia (B-ALL) patients relapsed after allogeneic hematopoietic stem cell transplantation (HSCT) using donor-derived CD19 CAR T cells generated with the Sleeping Beauty (SB) transposon and differentiated into cytokine-induced killer (CIK) cells.RESULTS The cellular product was produced successfully for all patients from the donor peripheral blood (PB) and consisted mostly of CD3+ lymphocytes with 43% CAR expression. Four pediatric and 9 adult patients were infused with a single dose of CAR T cells. Toxicities reported were 2 grade I and 1 grade II cytokine-release syndrome (CRS) cases at the highest dose in the absence of graft-versus-host disease (GVHD), neurotoxicity, or dose-limiting toxicities. Six out of 7 patients receiving the highest doses achieved CR and CR with incomplete blood count recovery (CRi) at day 28. Five out of 6 patients in CR were also minimal residual disease negative (MRD–). Robust expansion was achieved in the majority of the patients. CAR T cells were measurable by transgene copy PCR up to 10 months. Integration site analysis showed a positive safety profile and highly polyclonal repertoire in vitro and at early time points after infusion.CONCLUSION SB-engineered CAR T cells expand and persist in pediatric and adult B-ALL patients relapsed after HSCT. Antileukemic activity was achieved without severe toxicities.TRIAL REGISTRATION ClinicalTrials.gov NCT03389035.FUNDING This study was supported by grants from the Fondazione AIRC per la Ricerca sul Cancro (AIRC); Cancer Research UK (CRUK); the Fundación Científica de la Asociación Española Contra el Cáncer (FC AECC); Ministero Della Salute; Fondazione Regionale per la Ricerca Biomedica (FRRB).
Authors
Chiara F. Magnani, Giuseppe Gaipa, Federico Lussana, Daniela Belotti, Giuseppe Gritti, Sara Napolitano, Giada Matera, Benedetta Cabiati, Chiara Buracchi, Gianmaria Borleri, Grazia Fazio, Silvia Zaninelli, Sarah Tettamanti, Stefania Cesana, Valentina Colombo, Michele Quaroni, Giovanni Cazzaniga, Attilio Rovelli, Ettore Biagi, Stefania Galimberti, Andrea Calabria, Fabrizio Benedicenti, Eugenio Montini, Silvia Ferrari, Martino Introna, Adriana Balduzzi, Maria Grazia Valsecchi, Giuseppe Dastoli, Alessandro Rambaldi, Andrea Biondi
Citation information
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Recent advances and discoveries in the mechanisms and functions of CAR T cells
RC Larson, MV Maus |
Nature Reviews Cancer | 2021 |
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Improving and Maintaining Responses in Pediatric B–Cell Acute Lymphoblastic Leukemia Chimeric Antigen Receptor–T Cell Therapy
R Arya, DM Barrett, SA Grupp, JJ Melenhorst |
Cancer journal (Sudbury, Mass.) | 2021 |
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CAR T-Cell Production Using Nonviral Approaches
V Lukjanov, I Koutná, P Šimara, LA Ponce-Soto |
Journal of Immunology Research | 2021 |
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IL12 integrated into the CAR exodomain convertsCD8+ T cells to poly-functional NK-like cells with superior killing of antigen-loss tumors
A Hombach, M Barden, L Hannappel, M Chmielewski, G Rappl, A Sachinidis, H Abken |
Molecular Therapy | 2021 |
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CAR‐T therapy: Prospects in targeting cancer stem cells
X Cui, R Liu, L Duan, D Cao, Q Zhang, A Zhang |
Journal of Cellular and Molecular Medicine | 2021 |
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Scalable Manufacturing of CAR T Cells for Cancer Immunotherapy
M Abou-el-Enein, M Elsallab, SA Feldman, AD Fesnak, HE Heslop, P Marks, BG Till, G Bauer, B Savoldo |
2021 | |
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Choosing the Right Tool for Genetic Engineering: Clinical Lessons from Chimeric Antigen Receptor-T Cells
M Irving, E Lanitis, D Migliorini, Z Ivics, S Guedan |
Human Gene Therapy | 2021 |
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CARAMBA: a first-in-human clinical trial with SLAMF7 CAR-T cells prepared by virus-free Sleeping Beauty gene transfer to treat multiple myeloma
S Prommersberger, M Reiser, J Beckmann, S Danhof, M Amberger, P Quade-Lyssy, H Einsele, M Hudecek, H Bonig, Z Ivics |
Gene Therapy | 2021 |
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Autologous antigen-presenting cells efficiently expand piggyBac transposon CAR-T cells with predominant memory phenotype
K Nakamura, S Yagyu, S Hirota, A Tomida, M Kondo, T Shigeura, A Hasegawa, M Tanaka, Y Nakazawa |
Molecular Therapy — Methods & Clinical Development | 2021 |
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Nonviral genome engineering of natural killer cells
GM Robbins, M Wang, EJ Pomeroy, BS Moriarity |
Stem Cell Research & Therapy | 2021 |
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Signaling pathways in the regulation of cytokine release syndrome in human diseases and intervention therapy
X Li, M Shao, X Zeng, P Qian, H Huang |
Signal Transduction and Targeted Therapy | 2021 |
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MRD-Based Therapeutic Decisions in Genetically Defined Subsets of Adolescents and Young Adult Philadelphia-Negative ALL
M Tosi, O Spinelli, M Leoncin, R Cavagna, C Pavoni, F Lussana, T Intermesoli, L Frison, G Perali, F Carobolante, P Viero, C Skert, A Rambaldi, R Bassan |
Cancers | 2021 |
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Cellular Immunotherapy Targeting Cancer Stem Cells: Preclinical Evidence and Clinical Perspective
C Donini, R Rotolo, A Proment, M Aglietta, D Sangiolo, V Leuci |
Cells | 2021 |
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NKG2D Engagement Alone Is Sufficient to Activate Cytokine-Induced Killer Cells While 2B4 Only Provides Limited Coactivation
X Wu, A Sharma, J Oldenburg, H Weiher, M Essler, D Skowasch, IG Schmidt-Wolf |
Frontiers in immunology | 2021 |
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Immunotherapy of Acute Lymphoblastic Leukemia and Lymphoma With T Cell–Redirected Bispecific Antibodies
F Lussana, G Gritti, A Rambaldi |
Journal of Clinical Oncology | 2021 |
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Cytomorphology of Chimeric Antigen Receptor T-Cells (CAR-T)
E Galli, S Bellesi, M Viscovo, F Sorà, S Hohaus, N Piccirillo, L Laurenti, P Chiusolo, VD Stefano, S Sica, G Zini |
Mediterranean journal of hematology and infectious diseases | 2021 |
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Consolidative allogeneic hematopoietic stem cell transplantation after chimeric antigen receptor T-cell therapy for relapsed/refractory B-cell acute lymphoblastic leukemia: who? When? Why?
H Jiang, Y Hu, H Mei |
Biomarker Research | 2020 |
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