Preliminary Report of the Academic CAR-T (ISIKOK-19) Cell Clinical Trial in Turkey: Characterization of Product and Outcomes of Clinical Application

Autor:	Erdoğan E; Acıbadem Altunizade Hospital, Hematology Unit, İstanbul, Turkey, Yalçın K; Acıbadem Labcell Cellular Therapy Center, İstanbul, Turkey; Bahçeşehir University Medical Park Göztepe Hospital, Pediatric Bone Marrow Transplantation Unit, İstanbul, Turkey, Hemşinlioğlu C; Acıbadem Labcell Cellular Therapy Center, İstanbul, Turkey, Sezgin A; Acıbadem Altunizade Hospital, Hematology Unit, İstanbul, Turkey, Seyis U; Acıbadem Labcell Cellular Therapy Center, İstanbul, Turkey, Kançağı DD; Acıbadem Labcell Cellular Therapy Center, İstanbul, Turkey, Taştan C; Acıbadem Labcell Cellular Therapy Center, İstanbul, Turkey; Üsküdar University, Molecular Biology and Genetics Department of Transgenic Cell Technologies and Epigenetic Application and Research Center (TRGENMER), İstanbul, Turkey, Yurtsever B; Acıbadem Labcell Cellular Therapy Center, İstanbul, Turkey, Turan RD; Acıbadem Labcell Cellular Therapy Center, İstanbul, Turkey, Çakırsoy D; Acıbadem Labcell Cellular Therapy Center, İstanbul, Turkey, Abanuz S; Acıbadem Labcell Cellular Therapy Center, İstanbul, Turkey, Sır Karakuş G; Acıbadem Labcell Cellular Therapy Center, İstanbul, Turkey, Elek M; Acıbadem Labcell Cellular Therapy Center, İstanbul, Turkey, Bekoz HS; Medipol University Faculty of Medicine, Hematology Unit, İstanbul, Turkey, Gemici Aİ; Medipol University Faculty of Medicine, Hematology Unit, İstanbul, Turkey, Sargın D; Medipol University Faculty of Medicine, Hematology Unit, İstanbul, Turkey, Arat M; İstanbul Florence Nightingale Hospital, Hematology Unit, İstanbul, Turkey, Ferhanoğlu B; VKV American Hospital, Hematology Unit, İstanbul, Turkey, Pekgüç E; VKV American Hospital, Hematology Unit, İstanbul, Turkey, Örnek S; VKV American Hospital, Hematology Unit, İstanbul, Turkey, Büyüktaş D; VKV American Hospital, Hematology Unit, İstanbul, Turkey, Birgen N; Acıbadem Labcell Cellular Therapy Center, İstanbul, Turkey, Ratip S; Acıbadem Altunizade Hospital, Hematology Unit, İstanbul, Turkey, Ovalı E; Acıbadem Labcell Cellular Therapy Center, İstanbul, Turkey
Jazyk:	angličtina
Zdroj:	Turkish journal of haematology : official journal of Turkish Society of Haematology [Turk J Haematol] 2022 Aug 25; Vol. 39 (3), pp. 206-210. Date of Electronic Publication: 2022 Jul 18.
DOI:	10.4274/tjh.galenos.2022.2022.0193
Abstrakt:	Objective: Chimeric antigen receptor T (CAR-T) cell therapies have already made an impact on the treatment of B-cell malignancies. Although CAR-T cell therapies are promising, there are concerns about commercial products regarding their affordability and sustainability. In this preliminary study, the results of the first production and clinical data of an academic CAR-T cell (ISIKOK-19) trial in Turkey are presented. Materials and Methods: A pilot clinical trial (NCT04206943) designed to assess the safety and feasibility of ISIKOK-19 T-cell therapy for patients with relapsed and refractory CD19+ tumors was conducted and participating patients received ISIKOK-19 infusions between October 2019 and July 2021. The production data of the first 8 patients and the clinical outcome of 7 patients who received ISIKOK-19 cell infusions are presented in this study. Results: Nine patients were enrolled in the trial [5 with acute lymphoblastic leukemia (ALL) and 4 with non-Hodgkin lymphoma (NHL)], but only 7 patients could receive treatment. Two of the 3 participating ALL patients and 3 of the 4 NHL patients had complete/partial response (overall response rate: 72%). Four patients (57%) had CAR-T-related toxicities (cytokine release syndrome, CAR-T-related encephalopathy syndrome, and pancytopenia). Two patients were unresponsive and had progressive disease following CAR-T therapy. Two patients with partial response had progressive disease during follow-up. Conclusion: Production efficacy and fulfillment of the criteria of quality control were satisfactory for academic production. Response rates and toxicity profiles were also acceptable for this heavily pretreated/refractory patient group. ISIKOK-19 cells appear to be a safe, economical, and efficient treatment option for CD19+ tumors. However, the findings of this study need to be supported by the currently ongoing ISIKOK-19 clinical trial. Competing Interests: Conflict of Interest: No conflict of interest was declared by the authors. (©Copyright 2022 by Turkish Society of Hematology | Turkish Journal of Hematology, Published by Galenos Publishing House)
Databáze:	MEDLINE
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