CD19 CAR T Cells in Children and Adults With Relapsed or Refractory CD19 Positive B Cell Malignancies

Relapsed/Refractory B-Cell Malignancies Clinical Trial

Official title: Phase I Clinical Trial of CD19 Chimeric Antigen Receptor (CAR) T Cells in Children and Adults With Relapsed or Refractory CD19 Positive B Cell Malignancies

Status Not yet recruiting

Clinical Trial Summary

This study seeks to examine the feasibility and safety of the administration of autologous T cells that have been modified through the introduction of a chimeric antigen receptor targeting the B cell surface antigen CD19 following administration of chemotherapy lymphodepletion regimen in children and adults with relapsed/refractory B cell malignancies.

Clinical Trial Description

The overall goal of this study is to validate the safety profile of administration CD19 CAR T cells and describe the toxicities in children and adults with relapsed/ refractory B cell malignancies. The dose is escalated in standard 3 +3 design with a starting dose of 1x106 cell/kilogram and maximum treatment dose of 5 x 106 cell/kilogram. The minimum number of 9 subjects would occur if no dose-limiting toxicities are observed in the 3 dose escalation cohorts. The maximum sample size of 18 subjects would be enrolled in 3 dose escalation cohorts (six in each cohort) for meeting dose-limiting toxicities request. In addition, we hypothesize that we will be able to successfully manufacture CAR T cells to meet the established release criteria at a minimum target dose of 1 X 106 +-30% cells/kilogram in this patient population using the Miltenyi CliniMACS Prodigy® closed transduction system. ;

Related Conditions & MeSH terms

• Neoplasms
• Relapsed/Refractory B-Cell Malignancies

• NCT number: NCT04943016
• Study type: Interventional
• Source: National Taiwan University Hospital
• Contact: Jih-Luh Tang
• Phone: 886-0-72651057
• Email: tangntuh@gmail.com
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: July 1, 2021
• Completion date: December 31, 2024