Phase I Trial of 19-28zIL-18 CAR T-Cell Therapy for Adults and Adolescents with Relapsed or Refractory Acute Lymphoblastic Leukemia

What this Trial Is About

Researchers are evaluating a new CAR T-cell therapy called 19-28zIL-18 for adults and adolescents with relapsed or refractory acute lymphoblastic leukemia ALL, including Philadelphia chromosome-negative and positive types. This Phase I trial aims to study the safety and toxicity of this investigational treatment in patients who have not responded to previous therapies or have relapsed. The study is led by Memorial Sloan Kettering Cancer Center and focuses on patients aged 17 years and older. Participants will have their white blood cells collected through leukapheresis, and these T cells will be modified in a laboratory to create the 19-28zIL-18 CAR T-cell therapy over 2 to 4 weeks. Participants will receive one of three dose levels of CAR T cells, with or without lymphodepleting chemotherapy, to evaluate different dosing strategies. The study is non-randomized and open-label, meaning all participants know which dose they receive. During the study, researchers will monitor participants closely for toxicity and side effects up to 4 weeks using standard criteria. Patients will have various assessments including blood tests and organ function evaluations before and after treatment. The study includes patients with prior stem cell transplants and allows certain prior therapies if conditions are met. Overall participation length and follow-up beyond 4 weeks are not specified but safety and response will be carefully evaluated during the trial.

A Study of 19-28z/IL-18 in People With Acute Lymphoblastic Leukemia (ALL)