Study of Locally Made CD19 CAR-T Cell Therapy for Relapsed or Resistant Acute Lymphoblastic Leukemia and Non-Hodgkin Lymphoma in Patients Aged 3 to 70 Years

What this Trial Is About

Researchers are evaluating a new CD19-directed CAR-T cell therapy produced locally in Brazil for patients with refractory or relapsed acute lymphoblastic leukemia ALL or non-Hodgkin lymphoma NHL. This phase III clinical trial aims to study the safety and effectiveness of this treatment in 81 patients who have not responded to or have relapsed after previous therapies. Participants will undergo lymphocyte collection through apheresis, followed by CAR-T cell production involving activation, transduction, and expansion. Before receiving the CAR-T infusion, patients will be hospitalized and receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine for three days. On the infusion day, patients will receive a single intravenous dose of the academic CAR-T cells, with dosing adjusted based on body weight and disease type. Patients will remain hospitalized for at least two weeks after infusion for monitoring and will receive antiviral and anti-pneumocystis prevention. During the five-year follow-up, participants will be closely monitored for treatment safety, including early and late adverse events, and treatment effectiveness through measures such as response rates and survival. Evaluations include clinical assessments, laboratory tests, and toxicity monitoring. Participants must adhere to follow-up visits and treatments as required and will be observed for any side effects or complications throughout the study period.

CD19-directed CAR-T Cell Therapy for R/R Acute Leukemia and Lymphoma