NCT06393335

Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10-19) in the Treatment of Relapsed and/or Refractory CD19-positive B Cell Hematological Malignancies Clinical Research

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: The Children's Hospital of Zhejiang University School of Medicine · Academic / Other
• Sex: All
• Age: 6 Months – 18 Years
• Healthy volunteers: Not accepted

Summary

A Study of Metabolically Armed CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory CD19-positive B cell Hematological Malignancies

Detailed description

This is a single arm, open-label study. This study is indicated for relapsed or refractory CD19-positive B cell Hematological Malignancies. 1. Main research objectives: To evaluate the safety and efficacy of metabolically armed CD19 CAR-T Cells in the treatment of r/r CD19-positive B cell Hematological Malignancies 2. Secondary research objectives: 1. To evaluate the pharmacokinetic (PK) and pharmacodynamics(PD) characteristics of metabolically armed CD19 CAR-T Cells after infusion. 2. To evaluate tumor remission after infusion of metabolically armed CD19 CAR-T Cells.

Conditions

• Acute Lymphoblastic Leukemia
• Non-hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Metabolically Armed CD19 CAR-T cells	Each subject receive metabolically armed CD19 CAR- T cells by intravenous infusion.

Timeline

• Start date: 2024-05-15
• Primary completion: 2026-03-01
• Completion: 2026-03-15
• First posted: 2024-05-01
• Last updated: 2024-05-01

Locations

1 site across 1 country: China