CD19-Synthetic T Cell Antigen Receptor(STAR)-T in B-cell Malignancies Patients

B Cell Malignancy Clinical Trial

Official title: CD19-STAR-T for Patients With B Cell Malignancies

Status Completed

Clinical Trial Summary

This is a single center, single arm, open-lable phase I study to determine the safety and efficacy of CD19-STAR-T cells in patients with refractory and relapsed B-cell malignancies (such as NHL and ALL ).

Clinical Trial Description

This Phase I study is designed as a pilot trial evaluating the safety and of CD19-STAR-T cell therapy in subjects with refractory and relapsed B cell malignancies. Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3 followed by infusion of CD19-STAR-T cells. Safety and efficacy of CD19-STAR-T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19-STAR-T cells therapy in patients with refractory and relapsed B-cell malignancies. ;

Related Conditions & MeSH terms

• B Cell Malignancy
• Neoplasms

• NCT number: NCT03953599
• Study type: Interventional
• Source: Hebei Yanda Ludaopei Hospital
• Status: Completed
• Phase: Phase 1
• Start date: July 1, 2019
• Completion date: December 31, 2021