NCT04532281

A Study of Murine CD19 CAR-T Therapy for Patients With Relapsed or Refractory CD19+ B-cell Hematological Malignancies

Clinical Trial for the Safety and Efficacy of Murine CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia and B-cell Non-Hodgkin's Lymphoma

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

A Study of Murine CD19 CAR-T Cells Therapy for Patients With Relapsed or Refractory CD19+ B-cell Hematological Malignancies.

Detailed description

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

Conditions

• Acute Lymphoblastic Leukemia
• Non-Hodgkin Lymphoma of Soft Tissue

Interventions

Type	Name	Description
DRUG	Murine CD19 CAR-T cells	Each subject receive murine CD19 CAR T-cells by intravenous infusion

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