NCT04287309

CAR-T Cellular Therapy for B Cell Malignancies Involved in CNS

CAR-T Cellular Therapy for B Cell Malignancies Involved in Central Nervous System

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 3 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm, open-label, single-center study. This study is indicated for relapsed or refractory CD19+ B-line hematological malignancy involved in CNS. 20 patients were enrolled. Primary objective is to explore the safety. The secondary objective is to explore the efficacy.

Detailed description

This is a single arm, open-label, single-center study. This study is indicated for relapsed or refractory CD19+ B-line hematological malignancy involved in CNS. All together 20 patients were enrolled. Primary objective is to explore the safety including the complication of cytokine release syndrome, CRES, pancytopenia and infection. The secondary objective is to explore the efficacy. We will also detect CAR-T cell expansion dynamics in blood and cerebral fluid and compare the difference.

Conditions

• Hematological Malignancy

Interventions

Type	Name	Description
OTHER	CAR-T cells	CD19 targeted CAR-T treatment

Timeline

• Start date: 2020-02-28
• Primary completion: 2022-02-28
• Completion: 2023-02-28
• First posted: 2020-02-27
• Last updated: 2020-02-27

Locations

2 sites across 1 country: China