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2. T2EVOLVE: STANDARDIZATION OF PRE-CLINICAL AND CLINICAL DEVELOPMENT OF ENGINEERED T CELL THERAPY IN EUROPE; A CROSS FUNCTIONAL MULTI STAKEHOLDER INITIATIVE

Author

Luu, M., primary, Sanges, C., additional, Dreuillet, C., additional, Pennings, E., additional, Casucci, M., additional, Franz, P., additional, Donnadieu, E., additional, Quintarelli, C., additional, Guedan, S., additional, Kersten, M., additional, Morris, E., additional, Ivics, Z., additional, Jager, U., additional, Busch, D.H., additional, Gonzalez, E., additional, Paiva, B., additional, Schröder, B., additional, Chu, L., additional, Cabrizo, Y., additional, Ammar, D., additional, Junius, S., additional, Philippar, U., additional, Fleischer, A., additional, Awigena-Cook, J., additional, Schapitz, I., additional, Henderson, D., additional, Kremer, A., additional, Wagers, S., additional, Choudhary, R., additional, and Hudecek, M., additional

Published
2024
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3. POS1432 CAR-TREGS FOR SYSTEMIC LUPUS ERYTHEMATOSUS

Author

Doglio, M., primary, Ugolini, A., additional, Camisa, B., additional, Toma, C., additional, Norata, R., additional, Del Rosso, S., additional, Ciceri, F., additional, Sanvito, F., additional, Casucci, M., additional, Manfredi, A., additional, and Bonini, C., additional

Published
2023
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5. Human T cells engineered with a leukemia lipid-specific TCR enables donor-unrestricted recognition of CD1c-expressing leukemia

Author

Consonni, M, Garavaglia, C, Grilli, A, de Lalla, C, Mancino, A, Mori, L, De Libero, G, Montagna, D, Casucci, M, Serafini, M, Bonini, C, Häussinger, D, Ciceri, F, Bernardi, M, Mastaglio, S, Bicciato, S, Dellabona, P, Casorati, G, Consonni M, Garavaglia C, Grilli A, de Lalla C, Mancino A, Mori L, De Libero G, Montagna D, Casucci M, Serafini M, Bonini C, Häussinger D, Ciceri F, Bernardi M, Mastaglio S, Bicciato S, Dellabona P, Casorati G, Consonni, M, Garavaglia, C, Grilli, A, de Lalla, C, Mancino, A, Mori, L, De Libero, G, Montagna, D, Casucci, M, Serafini, M, Bonini, C, Häussinger, D, Ciceri, F, Bernardi, M, Mastaglio, S, Bicciato, S, Dellabona, P, Casorati, G, Consonni M, Garavaglia C, Grilli A, de Lalla C, Mancino A, Mori L, De Libero G, Montagna D, Casucci M, Serafini M, Bonini C, Häussinger D, Ciceri F, Bernardi M, Mastaglio S, Bicciato S, Dellabona P, and Casorati G

Abstract

Acute leukemia relapsing after chemotherapy plus allogeneic hematopoietic stem cell transplantation can be treated with donor-derived T cells, but this is hampered by the need for donor/recipient MHC-matching and often results in graft-versus-host disease, prompting the search for new donor-unrestricted strategies targeting malignant cells. Leukemia blasts express CD1c antigen-presenting molecules, which are identical in all individuals and expressed only by mature leukocytes, and are recognized by T cell clones specific for the CD1c-restricted leukemia-associated methyl-lysophosphatidic acid (mLPA) lipid antigen. Here, we show that human T cells engineered to express an mLPA-specific TCR, target diverse CD1c-expressing leukemia blasts in vitro and significantly delay the progression of three models of leukemia xenograft in NSG mice, an effect that is boosted by mLPA-cellular immunization. These results highlight a strategy to redirect T cells against leukemia via transfer of a lipid-specific TCR that could be used across MHC barriers with reduced risk of graft-versus-host disease.

Published
2021

6. Next-Generation Manufacturing Protocols Enriching TSCM CAR T Cells Can Overcome Disease-Specific T Cell Defects in Cancer Patients

Author

Arcangeli, S, Falcone, L, Camisa, B, De Girardi, F, Biondi, M, Giglio, F, Ciceri, F, Bonini, C, Bondanza, A, Casucci, M, Arcangeli S., Falcone L., Camisa B., De Girardi F., Biondi M., Giglio F., Ciceri F., Bonini C., Bondanza A., Casucci M., Arcangeli, S, Falcone, L, Camisa, B, De Girardi, F, Biondi, M, Giglio, F, Ciceri, F, Bonini, C, Bondanza, A, Casucci, M, Arcangeli S., Falcone L., Camisa B., De Girardi F., Biondi M., Giglio F., Ciceri F., Bonini C., Bondanza A., and Casucci M.

Abstract

Chimeric antigen receptor (CAR) T cell expansion and persistence emerged as key efficacy determinants in cancer patients. These features are typical of early-memory T cells, which can be enriched with specific manufacturing procedures, providing signal one and signal two in the proper steric conformation and in the presence of homeostatic cytokines. In this project, we exploited our expertise with paramagnetic beads and IL-7/IL-15 to develop an optimized protocol for CAR T cell production based on reagents, including a polymeric nanomatrix, which are compatible with automated manufacturing via the CliniMACS Prodigy. We found that both procedures generate similar CAR T cell products, highly enriched of stem cell memory T cells (TSCM) and equally effective in counteracting tumor growth in xenograft mouse models. Most importantly, the optimized protocol was able to expand CAR TSCM from B-cell acute lymphoblastic leukemia (B-ALL) patients, which in origin were highly enriched of late-memory and exhausted T cells. Notably, CAR T cells derived from B-ALL patients proved to be as efficient as healthy donor-derived CAR T cells in mediating profound and prolonged anti-tumor responses in xenograft mouse models. On the contrary, the protocol failed to expand fully functional CAR TSCM from patients with pancreatic ductal adenocarcinoma, suggesting that patient-specific factors may profoundly affect intrinsic T cell quality. Finally, by retrospective analysis of in vivo data, we observed that the proportion of TSCM in the final CAR T cell product positively correlated with in vivo expansion, which in turn proved to be crucial for achieving long-term remissions. Collectively, our data indicate that next-generation manufacturing protocols can overcome initial T cell defects, resulting in TSCM-enriched CAR T cell products qualitatively equivalent to the ones generated from healthy donors. However, this positive effect may be decreased in specific conditions, for which the developme

Published
2020

7. Time to evolve: predicting engineered T cell-associated toxicity with next-generation models

Author

Donnadieu, E., Luu, M., Alb, M., Anliker, B., Arcangeli, S., Bonini, C., De Angelis, B., Choudhary, R., Espie, D., Galy, A., Holland, C., Ivics, Z., Kantari-Mimoun, C., Kersten, M. J., Kohl, U., Kuhn, C., Laugel, B., Locatelli, Franco, Marchiq, I., Markman, J., Moresco, M. A., Morris, E., Negre, H., Quintarelli, C., Rade, M., Reiche, K., Renner, M., Ruggiero, E., Sanges, C., Stauss, H., Themeli, M., Van den Brulle, J., Hudecek, M., Casucci, M., Locatelli F. (ORCID:0000-0002-7976-3654), Donnadieu, E., Luu, M., Alb, M., Anliker, B., Arcangeli, S., Bonini, C., De Angelis, B., Choudhary, R., Espie, D., Galy, A., Holland, C., Ivics, Z., Kantari-Mimoun, C., Kersten, M. J., Kohl, U., Kuhn, C., Laugel, B., Locatelli, Franco, Marchiq, I., Markman, J., Moresco, M. A., Morris, E., Negre, H., Quintarelli, C., Rade, M., Reiche, K., Renner, M., Ruggiero, E., Sanges, C., Stauss, H., Themeli, M., Van den Brulle, J., Hudecek, M., Casucci, M., and Locatelli F. (ORCID:0000-0002-7976-3654)

Abstract

Despite promising clinical results in a small subset of malignancies, therapies based on engineered chimeric antigen receptor and T-cell receptor T cells are associated with serious adverse events, including cytokine release syndrome and neurotoxicity. These toxicities are sometimes so severe that they significantly hinder the implementation of this therapeutic strategy. For a long time, existing preclinical models failed to predict severe toxicities seen in human clinical trials after engineered T-cell infusion. However, in recent years, there has been a concerted effort to develop models, including humanized mouse models, which can better recapitulate toxicities observed in patients. The Accelerating Development and Improving Access to CAR and TCR-engineered T cell therapy (T2EVOLVE) consortium is a public-private partnership directed at accelerating the preclinical development and increasing access to engineered T-cell therapy for patients with cancer. A key ambition in T2EVOLVE is to design new models and tools with higher predictive value for clinical safety and efficacy, in order to improve and accelerate the selection of lead T-cell products for clinical translation. Herein, we review existing preclinical models that are used to test the safety of engineered T cells. We will also highlight limitations of these models and propose potential measures to improve them.

Published
2022

8. Bone marrow central memory and memory stem T-cell exhaustion in AML patients relapsing after HSCT

Author

Noviello, M, Manfredi, F, Ruggiero, E, Perini, T, Oliveira, G, Cortesi, F, De Simone, P, Toffalori, C, Gambacorta, V, Greco, R, Peccatori, J, Casucci, M, Casorati, G, Dellabona, P, Onozawa, M, Teshima, T, Griffioen, M, Halkes, C, Falkenburg, J, Stolzel, F, Altmann, H, Bornhauser, M, Waterhouse, M, Zeiser, R, Finke, J, Cieri, N, Bondanza, A, Vago, L, Ciceri, F, Bonini, C, Noviello M., Manfredi F., Ruggiero E., Perini T., Oliveira G., Cortesi F., De Simone P., Toffalori C., Gambacorta V., Greco R., Peccatori J., Casucci M., Casorati G., Dellabona P., Onozawa M., Teshima T., Griffioen M., Halkes C. J. M., Falkenburg J. H. F., Stolzel F., Altmann H., Bornhauser M., Waterhouse M., Zeiser R., Finke J., Cieri N., Bondanza A., Vago L., Ciceri F., Bonini C., Noviello, M, Manfredi, F, Ruggiero, E, Perini, T, Oliveira, G, Cortesi, F, De Simone, P, Toffalori, C, Gambacorta, V, Greco, R, Peccatori, J, Casucci, M, Casorati, G, Dellabona, P, Onozawa, M, Teshima, T, Griffioen, M, Halkes, C, Falkenburg, J, Stolzel, F, Altmann, H, Bornhauser, M, Waterhouse, M, Zeiser, R, Finke, J, Cieri, N, Bondanza, A, Vago, L, Ciceri, F, Bonini, C, Noviello M., Manfredi F., Ruggiero E., Perini T., Oliveira G., Cortesi F., De Simone P., Toffalori C., Gambacorta V., Greco R., Peccatori J., Casucci M., Casorati G., Dellabona P., Onozawa M., Teshima T., Griffioen M., Halkes C. J. M., Falkenburg J. H. F., Stolzel F., Altmann H., Bornhauser M., Waterhouse M., Zeiser R., Finke J., Cieri N., Bondanza A., Vago L., Ciceri F., and Bonini C.

Abstract

The major cause of death after allogeneic Hematopoietic Stem Cell Transplantation (HSCT) for acute myeloid leukemia (AML) is disease relapse. We investigated the expression of Inhibitory Receptors (IR; PD-1/CTLA-4/TIM-3/LAG-3/2B4/KLRG1/GITR) on T cells infiltrating the bone marrow (BM) of 32 AML patients relapsing (median 251 days) or maintaining complete remission (CR; median 1 year) after HSCT. A higher proportion of early-differentiated Memory Stem (T SCM ) and Central Memory BM-T cells express multiple IR in relapsing patients than in CR patients. Exhausted BM-T cells at relapse display a restricted TCR repertoire, impaired effector functions and leukemia-reactive specificities. In 57 patients, early detection of severely exhausted (PD-1 + Eomes + T-bet − ) BM-T SCM predicts relapse. Accordingly, leukemia-specific T cells in patients prone to relapse display exhaustion markers, absent in patients maintaining long-term CR. These results highlight a wide, though reversible, immunological dysfunction in the BM of AML patients relapsing after HSCT and suggest new therapeutic opportunities for the disease.

Published
2019

15. NY-ESO-1 TCR single edited t cells to treat multiple myeloma without inducing GvHD

Author

Mastaglio S, Genovese P, Magnani Z, Landoni E, Camisa B, Schiroli G, Provasi E, Lombardo A, Reik A, Cieri N, Rocchi M, Oliveira G, Escobar G, Casucci M, Gentner B, Spinelli A, Mondino A, Bondanza A, Vago L, Ponzoni M, Ciceri F, Holmes M, Naldini L, Bonini C, Mastaglio, S, Genovese, P, Magnani, Z, Landoni, E, Camisa, B, Schiroli, G, Provasi, E, Lombardo, A, Reik, A, Cieri, N, Rocchi, M, Oliveira, G, Escobar, G, Casucci, M, Gentner, B, Spinelli, A, Mondino, A, Bondanza, A, Vago, L, Ponzoni, M, Ciceri, F, Holmes, M, Naldini, L, and Bonini, C

Published
2016

16. Single Chain TCR Gene Editing in Adoptive Cell Therapy for Multiple Myeloma

Author

Mastaglio S, Genovese P, Magnani Z, Landoni E, Camisa B, Schiroli G, Provasi E, Lombardo A, Reik A, Cieri N, Rocchi M, Oliveira G, Escobar G, Casucci M, Gentner B, Spinelli A, Mondino A, Bondanza A, Vago L, Ponzoni M, Ciceri F, Holmes M, Naldini L, Bonini C, Mastaglio, S, Genovese, P, Magnani, Z, Landoni, E, Camisa, B, Schiroli, G, Provasi, E, Lombardo, A, Reik, A, Cieri, N, Rocchi, M, Oliveira, G, Escobar, G, Casucci, M, Gentner, B, Spinelli, A, Mondino, A, Bondanza, A, Vago, L, Ponzoni, M, Ciceri, F, Holmes, M, Naldini, L, and Bonini, C

Published
2016

17. CD44v6 as innovative sarcoma target for CAR-redirected CIK cells

Author

Leuci, V., primary, Casucci, M., additional, Grignani, G., additional, Rotolo, R., additional, Rossotti, U., additional, Vigna, E., additional, Gammaitoni, L., additional, Mesiano, G., additional, Fiorino, E., additional, Donini, C., additional, Pisacane, A., additional, ambrosio, L. D., additional, Pignochino, Y., additional, Aglietta, M., additional, Bondanza, A., additional, and Sangiolo, D., additional

Published
2018
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18. Acute Myeloid Leukemia Targeting by Chimeric Antigen Receptor T Cells: Bridging the Gap from Preclinical Modeling to Human Studies

Author

Rotiroti, M, Arcangeli, S, Casucci, M, Perriello, V, Bondanza, A, Biondi, A, Tettamanti, S, Biagi, E, Rotiroti, M, Arcangeli, S, Casucci, M, Perriello, V, Bondanza, A, Biondi, A, Tettamanti, S, and Biagi, E

Abstract

Acute myeloid leukemia (AML) still represents an unmet clinical need for adult and pediatric high-risk patients, thus demanding advanced and personalized therapies. In this regard, different targeted immunotherapeutic approaches are available, ranging from naked monoclonal antibodies (mAb) to conjugated and multifunctional mAbs (i.e., BiTEs and DARTs). Recently, researchers have focused their attention on novel techniques of genetic manipulation specifically to redirect cytotoxic T cells endowed with chimeric antigen receptors (CARs) toward selected tumor associated antigens. So far, CAR T cells targeting the CD19 antigen expressed by B-cell origin hematological cancers have gained impressive clinical results, leading to the possibility of translating the CAR platform to treat other hematological malignancies such as AML. However, one of the main concerns in the field of AML CAR immunotherapy is the identification of an ideal target cell surface antigen, being highly expressed on tumor cells but minimally present on healthy tissues, together with the design of an anti-AML CAR appropriately balancing efficacy and safety profiles. The current review focuses mainly on AML target antigens and the related immunotherapeutic approaches developed so far, deeply dissecting methods of CAR T cell safety improvements, when designing novel CARs approaching human studies.

Published
2017

21. Dual Transgenesis of T Cells with a CD44v6 CAR and a Suicide Gene for the Safe Eradication of Myeloid Leukemia and Myeloma

Author

Casucci M, Falcone L, di Robilant BN, Camisa B, Genovese P, Gentner B, Naldini L, Savoldo B, Dotti G, CICERI , FABIO, BORDIGNON, CLAUDIO, BONINI , MARIA CHIARA, BONDANZA , ATTILIO, Casucci, M, Falcone, L, di Robilant, Bn, Camisa, B, Genovese, P, Gentner, B, Naldini, L, Savoldo, B, Ciceri, Fabio, Bordignon, Claudio, Dotti, G, Bonini, MARIA CHIARA, Bondanza, Attilio, Nicolis, Di Robilant B., and Naldini, Luigi

Published
2012

25. Dual Transgenesis of T Cells with a Novel CD44v6-Specific Chimeric Antigen Receptor and a Suicide Gene for Safe and Effective Targeting of Chemoresistance in Hematopoietic Tumors

Author

Casucci M, Falcone L, di Robilant B. Nicolis, Camisa B, Genovese P, Gentner B, Naldini L, Savoldo B, CICERI, FABIO, BORDIGNON, CLAUDIO, Dotti G, BONINI , MARIA CHIARA, BONDANZA , ATTILIO, Casucci, M, Falcone, L, di Robilant B., Nicoli, Camisa, B, Genovese, P, Gentner, B, Naldini, L, Savoldo, B, Ciceri, Fabio, Bordignon, Claudio, Dotti, G, Bonini, MARIA CHIARA, and Bondanza, Attilio

Published
2011

26. Targeting chemoresistant myeloid leukaemia and multiple myeloma through genetic redirection of T cells against CD44 variant 6. Presented at the 19th Annual Meeting of the European Society of Gene and Cellular Therapy

Author

Casucci M, Falcone L, Camisa B, Nicolis di Robilant B, Genovese P, Naldini L, CICERI, FABIO, BORDIGNON, CLAUDIO, Savoldo B, Dotti G, Bondanza A., BONINI , MARIA CHIARA, Casucci, M, Falcone, L, Camisa, B, Nicolis di Robilant, B, Genovese, P, Naldini, L, Ciceri, Fabio, Bordignon, Claudio, Savoldo, B, Dotti, G, Bonini, MARIA CHIARA, and Bondanza, A.

Published
2011

27. Targeting of myeloid leukaemia stem cells through genetic redirection of T-cells against CD44v6

Author

Casucci, M, Falcone, L, Camisa, B, Nicolis di Robilant, B, Genovese, P, Savoldo, B, Dotti, G, NALDINI, LUIGI, CICERI, FABIO, BORDIGNON, CLAUDIO, BONINI, MARIA CHIARA, BONDANZA, ATTILIO, Casucci, M, Falcone, L, Camisa, B, Nicolis di Robilant, B, Genovese, P, Naldini, Luigi, Ciceri, Fabio, Bordignon, Claudio, Savoldo, B, Dotti, G, Bonini, MARIA CHIARA, and Bondanza, Attilio

Published
2011

29. Leukemic dendritic cells expand central-memory T lymphocytes from HCT donors able to react against the original leukemia in vitro and in vivo

Author

Casucci M, Perna SK, BONDANZA , ATTILIO, Magnani Z, Bernardi M, Crotta A, Tresoldi C, Fleischhauer K, Provasi E, Ponzoni M, CICERI , FABIO, BORDIGNON, CLAUDIO, Cignetti A, Bonini C., Casucci, M, Perna, Sk, Bondanza, Attilio, Magnani, Z, Bernardi, M, Crotta, A, Tresoldi, C, Fleischhauer, K, Provasi, E, Ponzoni, M, Ciceri, Fabio, Bordignon, Claudio, Cignetti, A, and Bonini, C.

Published
2010

31. Leukemic Dendritic Cells Expand Central Memory T Lymphocytes From HCT Donors Able to React against the Original Leukemia in Vitro and In Vivo

Author

Casucci M, Perna SK, BONDANZA , ATTILIO, Magnani Z, Bernardi M, Crotta A, Tresoldi C, Fleischhauer K, Provasi E, PONZONI , MAURILIO, Caligaris Cappio F, CICERI, FABIO, BORDIGNON, CLAUDIO, Cignetti A, BONINI , MARIA CHIARA, Casucci, M, Perna, Sk, Bondanza, Attilio, Magnani, Z, Bernardi, M, Crotta, A, Tresoldi, C, Fleischhauer, K, Provasi, E, Ponzoni, Maurilio, Caligaris Cappio, F, Ciceri, Fabio, Bordignon, Claudio, Cignetti, A, and Bonini, MARIA CHIARA

Published
2009

33. Immunostimulatory leukemic dendritic cells can efficiently expand leukemia-reactive T cells from HSCT donors

Author

Casucci M, Perna SK, BONDANZA , ATTILIO, Magnani Z, Bernardi M, Crotta A, Tresoldi C, Fleischhauer K, Caligaris Cappio F, CICERI, FABIO, BORDIGNON, CLAUDIO, Cignetti A, BONINI , MARIA CHIARA, Casucci, M, Perna, Sk, Bondanza, Attilio, Magnani, Z, Bernardi, M, Crotta, A, Tresoldi, C, Fleischhauer, K, Caligaris Cappio, F, Ciceri, Fabio, Bordignon, Claudio, Cignetti, A, and Bonini, MARIA CHIARA

Published
2009

35. Efficient differentiation of primary and secondary acute myeloid leukaemias into functionally competent leukaemic dendritic cells to improve graft-versus-leukemia effect

Author

Casucci M, Perna S, Magnani Z, Bernardi M, Crotta A, Cignetti A, Caligaris Cappio F, CICERI, FABIO, BORDIGNON, CLAUDIO, BONDANZA , ATTILIO, BONINI , MARIA CHIARA, Casucci, M, Perna, S, Bondanza, Attilio, Magnani, Z, Bernardi, M, Crotta, A, Cignetti, A, Caligaris Cappio, F, Ciceri, Fabio, Bordignon, Claudio, and Bonini, MARIA CHIARA

Published
2008

36. Efficient differentiation of primary and secondary acute myeloid leukemias into functionally competent leukemic dendritic cells to improve the graft versus leukemia effect

Author

Casucci M, Perna SK, BONDANZA , ATTILIO, Magnani Z, Bernardi M, Crotta A, Cignetti A, Tresoldi C, Fleischhauer K, Caligaris Cappio F, CICERI, FABIO, BORDIGNON, CLAUDIO, BONINI , MARIA CHIARA, Casucci, M, Perna, Sk, Bondanza, Attilio, Magnani, Z, Bernardi, M, Crotta, A, Cignetti, A, Tresoldi, C, Fleischhauer, K, Caligaris Cappio, F, Ciceri, Fabio, Bordignon, Claudio, and Bonini, MARIA CHIARA

Published
2008

37. Direct antigen presentation by leukemic dendritic cells promotes expansion of allogeneic leukemia-reactive T lymphocytes

Author

Casucci M, Perna SK, BONDANZA , ATTILIO, Magnani Z, Bernardi M, Crotta A, Cignetti A, Tresoldi C, Fleischhauer K, Caligaris Cappio F, CICERI, FABIO, BORDIGNON, CLAUDIO, BONINI , MARIA CHIARA, Casucci, M, Perna, Sk, Bondanza, Attilio, Magnani, Z, Bernardi, M, Crotta, A, Cignetti, A, Tresoldi, C, Fleischhauer, K, Caligaris Cappio, F, Ciceri, Fabio, Bordignon, Claudio, and Bonini, MARIA CHIARA

Published
2008

49. Arte, emotività, memoria

Author

Aveni Casucci, M. A., Cesa Bianchi, G., Tàmmaro, A. E., Cesa Bianchi, M., and Cristini, Carlo

Published
2001

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