Safety and Effectiveness of Anti-human CLL-1 CAR-NK Cell Treatment for Adults with Relapsed or Refractory Acute Myeloid Leukemia

What this Trial Is About

Researchers are evaluating anti-human CLL-1 CAR NK cells in adults aged 18 to 70 years with relapsed or refractory acute myeloid leukemia AML. This phase 1, open-label, single-arm dose-escalation trial aims to assess the safety, tolerability, and pharmacokinetics of these engineered cells, along with early observations on their potential effectiveness in this patient group. The study is sponsored by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine. Participants will receive a single dose infusion of CLL-1 CAR NK cells after lymphocyte collection from themselves or a donor and successful cell preparation. Four different dose levels will be tested, ranging from 5x106 to 4x107 CAR-NK cells per kilogram of body weight. The treatment process involves a careful escalation of doses to monitor safety and response. During the study, patients will be closely monitored for adverse events and dose-limiting toxicities between 14 and 28 days after infusion. Researchers will measure drug levels in plasma, evaluate response to treatment, and track survival outcomes for up to two years. Additional assessments include progression-free and overall survival, duration of response, and treatment-related side effects. Participants will also undergo evaluations of organ function and ability to tolerate the therapy throughout the study.

CLL-1 CAR-NK Cells for Relapsed/Refractory AML