December 7, 2021 -- Adicet Bio reported positive interim data from its dose escalation phase I study evaluating the safety and tolerability of ADI-001, Adicet's investigational gamma delta CAR T-cell therapy targeting CD20 for the potential treatment of B-cell non-Hodgkin's lymphoma.
Six patients were enrolled and received ADI-001. The first two who received the lowest dose did not reach the day 28 assessment and therefore were not evaluable. Three of the four evaluable patients achieved responses, including two complete responses (CR) and one partial response (PR) that investigators characterized as a near complete response.
Patients were heavily pretreated, with a median of five lines of prior systemic therapy, including a patient who had received prior autologous CD19 CAR T therapy and achieved complete response following a single infusion of ADI-001 administered at the lowest dose. Of the four evaluable patients, three received ADI-001 at dose level one (30 million CAR+ cells) and one received ADI-001 at dose level two (100 million CAR+ cells).
At dose level one, one patient achieved a CR, one patient achieved a PR that was characterized as a near CR, and one patient had progressive disease. In dose level two, the first patient achieved a CR.
Overall, ADI-001 infusions were generally well-tolerated, reported Adicet. No dose-limiting toxicities, graft versus host disease, immune effector cell-associated neurotoxicity syndrome, or grade III or higher cytokine release syndrome was reported, suggesting a potentially wide therapeutic window for ADI-001.