Phase 1 Study Evaluating CD371-Targeted CAR T Cell Therapy for Relapsed or Refractory Acute Myeloid Leukemia

What this Trial Is About

Researchers are evaluating the safety and dosing of CD371-YSNVZ-IL18 CAR T cells in people with relapsed or refractory Acute Myeloid Leukemia AML. This Phase 1 study aims to find the highest dose of these CAR T cells that causes few or mild side effects. The study is led by Memorial Sloan Kettering Cancer Center and focuses on patients with CD371-positive AML who have limited treatment options due to relapse or refractory disease. Participants receive escalating doses of CD371-specificYSNVZIL-18 CAR T cells along with lymphodepleting chemotherapy. The study includes several dose levels, including a step-down lower dose in case of severe toxicity. The goal is to establish the maximum tolerated dose MTD of the CAR T cells. The treatment groups include patients receiving different dose levels of the CAR T cells. During the study, participants undergo collection of T cells for CAR T cell manufacturing, and then treatment with the study CAR T cells. Researchers monitor the participants for up to 6 months to assess safety and side effects, including laboratory tests and clinical evaluations. Outcome measures focus on determining the maximum tolerated dose and evaluating participant health throughout the treatment and follow-up period.

A Study of CD371-YSNVZIL-18 CAR T Cells in People With Acute Myeloid Leukemia