Safety and Dose Study of CART19 Cells for Adults with Relapsed or Refractory CD19+ Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma

What this Trial Is About

Researchers are conducting a Phase I open-label study to evaluate the safety and appropriate dosing of CAR19 T cell therapy in adults with relapsed or refractory CD19-positive B-cell Acute Lymphoblastic Leukemia (B-ALL) or Non-Hodgkin's Lymphoma (B-NHL). This study includes up to 24 participants who have either not responded to previous treatments or have relapsed after stem cell transplantation. The goal is to determine the maximum tolerated or feasible dose of the CAR19 T cells for further research. Participants first receive a lymphodepleting chemotherapy regimen to prepare the body. Then, they are given a single dose of autologous CAR19 T lymphocytes, which are specially modified immune cells created from the patient's own cells by the sponsor's manufacturing facility. The dose of CAR19 cells will be increased in a stepwise manner among consecutive patients to find the recommended dose for future studies. Throughout the study, participants will be monitored closely for safety, including any adverse events occurring up to two years after treatment and specific dose-limiting toxicities within 28 days of the CAR19 cell administration. Evaluations include clinical assessments, laboratory tests, and other monitoring procedures to understand the treatment's effects and safety profile. The study involves detailed follow-up to assess outcomes and ensure patient well-being over the long term.

CART19 Cells Effects in Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma