Background:The treatment of relapsed/refractory AML (r/r AML) patients are still an unmet medical need in clinic. In recent years, cellular immunotherapy especially CAR-T cell therapy played more important roles in hematological malignancies. Unfortunately, the safety and efficacy of existing cell therapies to r/r AML patients still facing many challenges and needs to be further improved. Our previous studies have demonstrated that Double Negative T cells (DNTs) showed strong cytotoxicity to AML blasts and can improve the prognosis of AML patients relapsed after allogeneic stem cell transplantation. Here, we reported our ongoing phase I clinical trial of RC1012 injection (allogeneic DNT cells) in patients with r/r AML (NCT05471323). This study protocol was approved by Chinese NMPA (National Medical Products Administration). Informed consent was obtained in accordance with the Declaration of Helsinki.