NCT05864924

A Phase 1 Study of BRG01 in Subjects With Relapsed/Metastatic Epstein-Barr Virus (EBV)-Positive Nasopharyngeal Carcinoma

A Phase 1 Study Evaluating the Safety and Efficacy of BRG01 in Subjects With Relapsed/Metastatic EBV-positive Nasopharyngeal Carcinoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: BioSyngen Pte Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Phase 1 study evaluating the safety and efficacy of BRG01 in subjects with relapsed/ metastatic EBV-positive nasopharyngeal carcinoma (NPC). BRG01 is a Chimeric Antigen Receptor T-Cell therapy targetting on the specific protein of EBV, which is expressed on the EBV associated cancer cells. This study adopts the traditional "3+3" dose escalation design. Approximately12\~18 EBV+ NPC subjects will be enrolled to evaluate the safety of BRG01. An internal safety review team (SRT) will review the safety data and make recommendations on further study conduct and progression to subsequential cohorts. Subjects will be enrolled into 3 cohorts of different doses, designated as cohort A, B and C.Cohort A: 3.0x10\^6 CAR-T cells/kg,3 subjects, Cohort B: 9.0x10\^6 CAR-T cells/kg,3 subjects, and Cohort C:1.5x10\^7 CAR-T cells /kg, 6 subjects,respectively. Subjects in each cohort will follow the same treatment schedule and procedural requirements.

Detailed description

Primary Objective: To evaluate the safety and efficacy of BRG01. Secondary Objectives: 1. To evaluate the pharmacokinetics (PK)，pharmacodynamics (PD) and immunogenicity of BRG01. 2. To evaluate the preliminary efficacy of BRG01 in patients with relapsed/metastatic EBV+ NPC. Exploratory Objectives: 1. To explore the correlation between the proliferation and persistence of BRG01 cells in vivo and the efficacy. 2. To explore the correlation between target expression level in tumor tissue with the safety and efficacy. 3. To explore the correlation between plasma EBV DNA level with safety and efficacy.

Conditions

• EBV-positive Nasopharyngeal Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Cohort A: 3.0x10^6 CAR-T cells/kg	Intravenous infusion
BIOLOGICAL	Cohort B: 9.0x10^6CAR-T cells/kg	Intravenous infusion
BIOLOGICAL	Cohort C:1.5x10^7 CAR-T cells /kg	Intravenous infusion

Timeline

• Start date: 2023-05-10
• Primary completion: 2024-04-26
• Completion: 2024-04-26
• First posted: 2023-05-18
• Last updated: 2024-05-08

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study