NCT03953599

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

CD19-STAR-T for Patients With B Cell Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Hebei Yanda Ludaopei Hospital · Academic / Other
• Sex: All
• Age: 1 Year – 70 Years
• Healthy volunteers: Not accepted

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 ).

Detailed 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.

Conditions

• B Cell Malignancy

Interventions

Type	Name	Description
BIOLOGICAL	CD19-STAR-T cells	CD19-STAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of STAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 250mg/m2 for 3 days and take a rest for 2 days before infusion.

Timeline

• Start date: 2019-07-01
• Primary completion: 2021-07-01
• Completion: 2021-12-31
• First posted: 2019-05-16
• Last updated: 2022-02-01

Locations

1 site across 1 country: China