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

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.

Timeline

Start

2023-05-10

Primary completion

2024-04-26

Completion

2024-04-26

Drugs

Indications