Intellia Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the investigational new drug (IND) application for NTLA-5001, the company’s first wholly-owned ex vivo CRISPR genome editing candidate for the treatment of cancer. NTLA-5001 is an autologous T cell receptor (TCR)-T cell therapy engineered to target the Wilms’ Tumor (WT1) antigen for the treatment of all genetic subtypes of acute myeloid leukemia (AML). The company intends to initiate patient screening by year-end in a Phase 1/2a study evaluating NTLA-5001 in adults with persistent or recurrent AML who have previously received first-line therapy. The Phase 1/2a study will evaluate the safety, tolerability, cell kinetics and anti-tumor activity of a single dose of NTLA-5001 in adults who have detectable AML after having received standard first-line therapy. The study will contain a dose escalation and expansion phase, with up to 54 participants. The dose-escalation phase of the study will include two independent arms of up to three cohorts: Arm 1 will consist of adults with AML with lower disease burden, defined as those with less than 5% AML blasts in bone marrow, while Arm 2 will consist of adults with AML with higher disease burden, defined as those greater than or equal to 5% AML blasts in bone marrow. Once a dose is identified in each arm, two expansion cohorts will be opened for further safety assessment. In addition to the U.S., the company has also submitted a regulatory application to the U.K. for NTLA-5001.