Phase 1 Study Testing Safety and Effects of CLL1-Targeted CAR-NK Cell Therapy in Adults with Relapsed or Refractory Acute Myeloid Leukemia

What this Trial Is About

Researchers are evaluating a new treatment using natural killer NK cells engineered to target CLL1 in adults with relapsed or refractory acute myeloid leukemia AML. This phase 1, open-label study aims to assess the safety, tolerability, and early signs of effectiveness of this first-in-human therapy. AML is a serious blood cancer where the prognosis worsens after relapse, and CLL1 is a promising target because it is highly expressed on AML cells but not on normal blood stem cells. The treatment involves infusing patients with induced pluripotent stem cell iPSC derived CAR-NK cells that target CLL1. Participants will receive lympho-conditioning drugs including cyclophosphamide, fludarabine, and VP-16 before the CAR-NK cell infusion to prepare their bodies. This therapy is given to adult patients with relapsed or refractory AML who are positive for CLL1 expression on their leukemia cells. Throughout the study, participants will be monitored closely for treatment-related side effects and dose-limiting toxicities during the first 28 days after infusion. Researchers will also study how the CAR-NK cells behave in the blood over approximately two years after treatment. Evaluations include physical exams, blood tests, and assessment of organ function. The total duration of participation varies, with long-term follow-up to better understand the therapys pharmacokinetics and safety.

Natural Killer(NK) Cell Therapy Targeting CLL1 in Acute Myeloid Leukemia