NCT04008251

Humanized CD19 Chimeric Antigen Receptor (CAR)-Modified T Cell Therapy in Treating Patients With B-cell Malignancies

Treatment of Relapsed or Refractory B-cell Malignancies by Humanized CD19 Chimeric Antigen Receptor (CAR)-Modified T Cells

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Wuhan Sian Medical Technology Co., Ltd · Industry
• Sex: All
• Age: 14 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm, open-label study to evaluate the safety and efficacy of humanized anti-CD19 CAR-T cells in patients with relapsed or refractory B cell Malignancies.

Detailed description

Chimeric antigen receptor (CAR)-modified T cells (CAR-T cells) have the capabilities to recognize tumor associated antigen and kill tumor cells specifically. CAR-T therapy showed great effect on patients with relapsed or refractory B cell malignancies. To improve the efficacy and safety, the researchers designed a second-generation humanized CAR, consisting of humanized CD19 single chain variable fragment (scFv) and CD137 costimulatory domain. This study aims to evaluate the safety and effectiveness of humanized anti-CD19 CAR-T cells in patients with relapsed or refractory B cell Malignancies.

Conditions

• Acute Lymphoblastic Leukemia
• B Cell Lymphoma

Interventions

Type	Name	Description
GENETIC	Second generation humanized CAR-T cells	Patients receive humanized CD19 CAR-T cells transduced with a lentiviral vector on days 0/1/2 in the absence of disease progression or unacceptable toxicity.

Timeline

• Start date: 2019-05-27
• Primary completion: 2022-07-01
• Completion: 2022-12-31
• First posted: 2019-07-05
• Last updated: 2019-08-07

Locations

1 site across 1 country: China