Phase III Study of Allogeneic CARCIK-CD19 Cell Therapy for Adults and Children With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia

What this Trial Is About

Researchers are evaluating the engraftment, safety, and clinical activity of a new gene therapy called CARCIK-CD19 in both adult and pediatric patients who have relapsed or refractory mature B-cell cancers, including B-cell non-Hodgkin lymphoma NHL and chronic lymphocytic leukemia CLL. This phase III, open-label, single-arm, multi-center study focuses on patients who have limited treatment options and are expected to express the CD19 molecule on their cancer cells. The CARCIK-CD19 cells are produced from the blood of a related donor who shares at least half of the genetic markers. The treatment involves infusing participants with allogeneic cytokine-induced killer CIK T cells that have been genetically modified to target the CD19 protein found on B cells. These modified cells express a chimeric antigen receptor CAR designed to recognize and attack B-cell cancers. The therapy uses a specific CAR construct combining several signaling domains to enhance its activity. The study includes only one treatment group receiving this experimental CARCIK-CD19 therapy. Participants will be closely monitored for safety and treatment effects, including checking for dose-limiting toxicities within 28 days after infusion and assessing overall response three months after treatment. Researchers will also track adverse events for up to 12 months. Patients undergo various clinical assessments, imaging scans, and laboratory tests to evaluate their health status, disease response, and the behavior of the infused cells. The study aims to provide detailed information about how well the therapy works and its safety profile over time.

Allogeneic CARCIK-CD19 in Adults/Pediatric B-cell NHL or Chronic Lymphocytic Leukemia