NCT05747157

Safety and Efficacy of Metabolically Armed CD19 CAR-T Cells (Meta10- 19) in the Treatment of r/r B-ALL Clinical Research

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Anhui Provincial Hospital · Other Government
• Sex: All
• Age: 3 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A Study of Metabolically Armed CD19 CAR-T Cells Therapy for Patients With Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia

Detailed description

This is a single arm , open-label study. This study is indicated for relapsed and/or refractory CD19+ B-cell Acute Lymphoblastic Leukemia . The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 1. Main research objectives: To evaluate the safety and efficacy of metabolically armed CD19 CAR-T Cells in the treatment of r/r B-ALL. 2. Secondary research objectives: A. To evaluate the pharmacokinetic (PK) and pharmacodynamics(PD) characteristics of metabolically armed CD19 CAR-T Cells after infusion. B. To evaluate tumor remission after infusion of metabolically armed CD19 CAR-T Cells.

Conditions

• B-cell Acute Lymphoblastic Leukemia

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: 2023-02-15
• Primary completion: 2025-02-01
• Completion: 2025-05-15
• First posted: 2023-02-28
• Last updated: 2023-11-21

Locations

1 site across 1 country: China