EBV-positive Nasopharyngeal Carcinoma Clinical Trial
Official title:
A Phase 1 Study Evaluating the Safety and Efficacy of BRG01 in Subjects With Relapsed/Metastatic EBV-positive Nasopharyngeal Carcinoma
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT02065362 -
TGF-beta Resistant Cytotoxic T-lymphocytes in Treatment of EBV-positive Nasopharyngeal Carcinoma / RESIST-NPC
|
Phase 1 |