NCT04532203

A Study of CAR-T Cells Therapy for Patients With Relapsed and/or Refractory Central Nervous System Hematological Malignancies

Clinical Trial for the Safety and Efficacy of CAR-T Cells Therapy for Patients With the Central Nervous System Involvement of Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia or B-cell Non-Hodgkin's Lymphoma

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 3 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Study of CAR-T Cells Therapy for Patients With Relapsed and/or Refractory Central Nervous System Hematological Malignancies

Detailed description

This is a single arm, open-label, single-center study. This study is indicated for relapsed or refractory central nervous system CD19+ B-cell hematological malignancies, including acute lymphoblastic leukemia and B-cell non-Hodgkin's lymphoma. The selections of dose levels and the numberof subjects are based on clinical trialsof similar foreign products. Two groups of patients will be enrolled, 36 in eachgroup. Primary objective is to explore the safety, main consideration is dose-related safety.

Conditions

• Acute Lymphoblastic Leukemia
• Non-Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	CAR-T cells	Each subject receive CAR T-cells by intravenous infusion
PROCEDURE	Ommaya Reservoir	Surgical catheter placement into the fourth ventricle of the brain

Timeline

• Start date: 2020-11-01
• Primary completion: 2023-11-01
• Completion: 2026-11-01
• First posted: 2020-08-31
• Last updated: 2020-10-26

Locations

1 site across 1 country: China