Celyad has published a patient case study of its Phase 1 THINK trial, designed to evaluate the effect of Natural Killer Group 2D (NKG2D) CAR-T cell therapy in relapsed/refractory acute myeloid leukemia (AML). The trial is different from other CAR-T therapies in that no lymphodepletion was used prior to the CAR-T therapy.
The 52-year old AML patient received NKG2D-CAR T therapy at an initial dose of 3×108 cells every 2 weeks for 3 administrations without any lymphodepleting chemotherapy. The treatment was well tolerated by the patient and there were no significant treatment-related toxicities. Bone marrow evaluation 28 days following two infusions showed morphologic leukemia-free state and this was confirmed again at 3-months post infusion. The patient also had resolution of symptoms with improved hematopoiesis. The patient then underwent an allo-hematopoietic stem cell transplant (allo-HSCT) on day 97 post CAR-T infusion. Disease evaluation 100 days post allo-HSCT (and 197 post CAR-T therapy infusion) showed that the patient achieved a complete molecular remission. To date, the patient has maintained clinical response 6 months from allo-HSCT and 9 months following initial CYAD-01 infusion. The results were published in Haematologica. The Celyad-sponsored study was conducted by investigators at the Moffitt Cancer Center and Research Institute, Florida.
The THINK (THerapeutic Immunotherapy with NKR-2) trial is a multi-centre, dose-escalation, Phase 1b study designed to investigate the safety and clinical activity of administering multiple doses of autologous NKR-2 CAR T-cells in patients with seven refractory cancers including five solid tumors (colorectal, ovarian, bladder, triple-negative breast and pancreatic cancers) and two hematological tumors (acute myeloid leukemia and multiple myeloma).
Frédéric Lehmann, Celyad’s VP of Clinical Development and Medical Affairs commented: “Our results demonstrate the validity of NKG2D as a target, in particular in the context of refractory AML and without other intervening treatments nor preconditioning. We look forward to continue our clinical development plan for our NKG2D CAR based platform and explore the various conditions within which this therapy could provide benefits to patients with end stage cancers.”
Source: Haematologica publishes Celyad THINK Study Case Report of CYAD-01 Induced Complete Remission in Relapsed/Refractory AML Patient; Press Release