Phase III Study of Third-Generation CD19 CAR T Cell Therapy for Adults and Children with Relapsed or Refractory CD19 Lymphoid Cancers

What this Trial Is About

Researchers are evaluating the safety and feasibility of a new treatment using specially modified T cells called CD19.CAR T cells in patients with relapsed or refractory CD19-positive lymphoid diseases. This includes adults with acute lymphoblastic leukemia ALL, chronic lymphocytic leukemia CLL, diffuse large B-cell lymphoma DLBCL, follicular lymphoma FL, mantle cell lymphoma MCL, and pediatric patients with ALL. The study is a Phase III clinical trial led by the University Hospital Heidelberg. Participants receive escalating doses of CD19.CAR T cells after a preparatory treatment called lymphodepletion using fludarabine and cyclophosphamide. The doses range from 1x106 to 20x107 transduced cells per square meter of body surface area. The study includes three groups adults with relapsed or refractory ALL, adults with relapsed or refractory CLL or lymphomas, and children with relapsed or refractory ALL. During the trial, researchers monitor participants closely for safety by assessing side effects such as cytokine release syndrome and neurotoxicity for up to 90 days after treatment. They also evaluate the feasibility of producing the modified T cells before administration. Participants undergo various clinical assessments, including performance status, organ function tests, and disease measurements. The study aims to gather important information on the treatments safety and manufacturing process over time, with the trial expected to continue until the end of 2027.

Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR