NCT05741359

The Safety and Efficacy of BRL-201 in the Treatment of r/r B Lymphocyte Non-Hodgkin Lymphoma

A Phase I/II Clinical Study of the Safety and Efficacy of CD19-targeted Non-viral PD1 Site-specific Integrated CAR-T Cell Injection (BRL-201) in the Treatment of Relapsed or Refractory B Lymphocyte Non-Hodgkin Lymphoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Bioray Laboratories · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, single-arm, open-label clinical study, and the sample size is set to 12-18 subjects.

Detailed description

This is a multi-center, single-arm, open-label clinical study, and the sample size is set to 12-18 subjects. Based on the "3 + 3" dose escalation design principle, subjects will be divided into 3 groups from low dose to high dose in sequence (Group A; Group B; Group C. Additional subjects will be enrolled into the RP2D group to ensure that 6-9 efficacy-evaluable subjects are available in the RP2D group before entering the phase II study.

Conditions

• Non-hodgkin Lymphoma,B Cell

Interventions

Type	Name	Description
DRUG	CD19-targeted non-viral PD1 site-specific integrated CAR-T cell injection	CD19-targeted non-viral PD1 site-specific integrated CAR-T cell injection

Timeline

• Start date: 2023-04-25
• Primary completion: 2026-11-20
• Completion: 2027-01-15
• First posted: 2023-02-23
• Last updated: 2025-11-25

Locations

3 sites across 1 country: China