Phase 1 Study of A-CAR028, a New CAR-T Cell Therapy, in Adults With Relapsed or Refractory Acute Myeloid Leukemia

What this Trial Is About

Researchers are evaluating the safety and effectiveness of A-CAR028, a new 2nd generation CAR-T cell therapy that targets CD33 and CLL-1 antigens, in patients with relapsed or refractory acute myeloid leukemia AML. This phase 1, open-label study is conducted at a single center and sponsored by the First Affiliated Hospital of Zhejiang University. The trial aims to better understand how this treatment works and its potential risks in this specific patient group. The study involves several steps screening to confirm eligibility, collecting immune cells through apheresis to create the personalized A-CAR028 therapy, baseline testing, lymphodepletion to prepare the body, and then intravenous infusion of A-CAR028. After the infusion, participants are monitored closely for dose-limiting toxicities during the first 28 days, followed by ongoing observation of treatment-related adverse events for up to three months and further follow-up lasting two years. This process helps evaluate both short- and long-term safety and response to the treatment. Participants will undergo regular assessments including safety checks, laboratory tests, and evaluations of leukemia response using bone marrow samples and blood tests. Researchers will track adverse events, response rates, survival, and pharmacokinetic measures such as drug concentration over time. The study spans from screening through a two-year follow-up period after infusion, ensuring thorough observation of treatment impact and patient health throughout the trial.

A Study of A-CAR028 Treatment in Subjects With Relapsed or Refractory Acute Myeloid Leukemia