NCT06047197

Phase I Clinical Trial of RC19D2 Cell Injection in the Treatment of Diffuse Large B-cell Lymphoma

Phase I Clinical Trial of Dinorencel Injection (or RC19D2 Cell Injection) in the Treatment of CD19-positive Relapsed or Refractory Diffuse Large B-cell Lymphoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Beijing Yongtai Ruike Biotechnology Company Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial is a phase I clinical trial aimed at the safety and tolerability of RC19D2 cell injection in the treatment of CD19 positive patients with recurrent or refractory diffuse large B-cell lymphoma

Detailed description

This trial is a Phase I clinical trial, which is divided into two trial stages. The first stage is a dose-increasing trial stage The second stage is the dose extension experiment stage. The main endpoint is to evaluate its tolerance and safety. The first dose group used rapid titration method for dose increase, and the subsequent dose groups used the classic 3+3 experimental design for dose increase. A total of 4 dose groups are planned to be set up. The second to fourth dose groups will include 3-6 participants in each group

Conditions

• Recurrent Diffuse Large B-Cell Lymphoma
• Refractory Diffuse Large B-cell Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	RC19D2 cell injection	The functional component of RC19D2 cell injection is T cells that have been genetically modified to express anti CD19 chimeric antigen receptors.

Timeline

• Start date: 2023-09-05
• Primary completion: 2026-09-05
• Completion: 2026-12-05
• First posted: 2023-09-21
• Last updated: 2024-08-27

Locations

1 site across 1 country: China