NCT06716164

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

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 19 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 Non-Hodgkin lymphoma

Detailed description

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

Conditions

• Non-hodgkin Lymphoma,B Cell

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: 2024-12-01
• Primary completion: 2026-12-01
• Completion: 2027-04-05
• First posted: 2024-12-04
• Last updated: 2024-12-04

Locations

1 site across 1 country: China