TY - JOUR
T1 - Preliminary Report of the Academic CAR-T (ISIKOK-19) Cell Clinical Trial in Turkey
T2 - Characterization of Product and Outcomes of Clinical Application
AU - Erdoğan, Ebru
AU - Yalçın, Koray
AU - Hemşinlioğlu, Cansu
AU - Sezgin, Aslıhan
AU - Seyis, Utku
AU - Kancağı, Derya Dilek
AU - Taştan, Cihan
AU - Yurtsever, Bulut
AU - Turan, Raife Dilek
AU - Çakırsoy, Didem
AU - Abanuz, Selen
AU - Karakuş, Gözde Sır
AU - Elek, Muhammer
AU - Beköz, Hüseyin Saffet
AU - Gemici, Ali İhsan
AU - Sargın, Deniz
AU - Arat, Mutlu
AU - Ferhanoğlu, Burhan
AU - Pekgüç, Ebru
AU - Örnek, Serdar
AU - Büyüktaş, Deram
AU - Birgen, Nur
AU - Ratip, Siret
AU - Ovalı, Ercüment
N1 - Publisher Copyright:
© 2022 by Turkish Society of Hematology Turkish Journal of Hematology, Published by Galenos Publishing House.
PY - 2022
Y1 - 2022
N2 - 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.
AB - 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.
KW - Acute lymphoblastic leukemia
KW - Chimeric antigen receptor T (CAR-T) cell
KW - Gene therapy
KW - Non-Hodgkin lymphoma
UR - http://www.scopus.com/inward/record.url?scp=85136927167&partnerID=8YFLogxK
U2 - 10.4274/tjh.galenos.2022.2022.0193
DO - 10.4274/tjh.galenos.2022.2022.0193
M3 - Article
C2 - 35848614
AN - SCOPUS:85136927167
SN - 1300-7777
VL - 39
SP - 206
EP - 210
JO - Turkish Journal of Hematology
JF - Turkish Journal of Hematology
IS - 3
ER -