Phase I Study of Genetically Modified T Cells CAR-T for Treating Relapsed or Refractory CD19-positive B Cell Cancers in Patients Aged 2 to 70

What this Trial Is About

Researchers are studying the safety and appropriate dosing of a new treatment using genetically engineered T cells called CAR-T cells for patients with relapsed or refractory CD19-positive B cell cancers, including acute lymphoblastic leukemia ALL, non-Hodgkin lymphoma NHL, and chronic lymphocytic leukemia CLL. This phase 1, open-label trial includes both adult and pediatric patients divided into three groups based on their disease type pediatric ALL and aggressive pediatric NHL, adult ALL, and adult NHLCLL. The aim is to find the recommended dose for future studies while monitoring safety closely. Participants will receive a lymphodepleting chemotherapy regimen with Cyclophosphamide and Fludarabine before getting an infusion of CAR-T cells on day 0. The study uses a dose-escalation design where different dose levels of CAR-T cells are tested in small groups to identify the highest safe dose. If side effects called dose-limiting toxicities occur, dosing adjustments and expansions of patient groups are made to ensure safety. Several dose levels are planned, starting with lower doses and increasing if tolerated. During the study, patients will be monitored closely for adverse effects and treatment response through blood tests, imaging, and clinical exams. Researchers will assess the recommended CAR-T cell dose up to 28 days after infusion and evaluate treatment outcomes at multiple time points up to several years. Long-term follow-up includes monitoring overall survival, disease progression, and the persistence of CAR-T cells in the body. Participation may last several years to fully capture these outcomes and ensure patient safety.

Clinical Trial Using CAR- T Cells for Treatment of Patients With Refractory or Relapsed CD19-positive B Lymphoid Malignancies