A Phase 1 Study of BRG01 in Subjects With Relapsed/Metastatic Epstein-Barr Virus (EBV)-Positive Nasopharyngeal Carcinoma
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|ClinicalTrials.gov Identifier: NCT05864924|
Recruitment Status : Not yet recruiting
First Posted : May 18, 2023
Last Update Posted : May 18, 2023
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.
|Condition or disease||Intervention/treatment||Phase|
|EBV-positive Nasopharyngeal Carcinoma||Biological: Cohort A: 3.0x10^6 CAR-T cells/kg Biological: Cohort B: 9.0x10^6CAR-T cells/kg Biological: Cohort C:1.5x10^7 CAR-T cells /kg||Phase 1|
To evaluate the safety and efficacy of BRG01.
- To evaluate the pharmacokinetics (PK)，pharmacodynamics (PD) and immunogenicity of BRG01.
- To evaluate the preliminary efficacy of BRG01 in patients with relapsed/metastatic EBV+ NPC.
- To explore the correlation between the proliferation and persistence of BRG01 cells in vivo and the efficacy.
- To explore the correlation between target expression level in tumor tissue with the safety and efficacy.
- To explore the correlation between plasma EBV DNA level with safety and efficacy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study Evaluating the Safety and Efficacy of BRG01 in Subjects With Relapsed/Metastatic EBV-positive Nasopharyngeal Carcinoma|
|Estimated Study Start Date :||May 10, 2023|
|Estimated Primary Completion Date :||January 31, 2028|
|Estimated Study Completion Date :||January 31, 2028|
Experimental: BRG01 injection
Biological: Cohort A: 3.0x10^6 CAR-T cells/kg
Biological: Cohort B: 9.0x10^6CAR-T cells/kg
Biological: Cohort C:1.5x10^7 CAR-T cells /kg
- Dose-Limiting Toxicity (DLT) [ Time Frame: From the infusion (Day 0) to Day 28 ]Incidence of adverse events defined as Dose-Limiting Toxicity (DLT).
- Maximum tolerated dose [ Time Frame: From the infusion (Day 0) to Day 28 ]The maximum CAR-T dose that can be tolerated in the study.
- AE, SAE, AESI, CRS, ICANS, TEAE [ Time Frame: The day of leukapheresis to 3 months after infusion ]The incidence of adverse events (AE), serious adverse events (SAE), adverse events of special interest (AESI), cytokine release syndrome (CRS) immune cell associated neurotoxicity syndrome (ICANS) and treatment-emergent adverse events (TEAE).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05864924
|Contact: Zhezhao Liangfirstname.lastname@example.org|
|Sun Yat-sen University Cancer Center|
|Guangzhou, Guangdong, China, 510000|
|Contact: Hongyun Zhao|
|Principal Investigator: Li Zhang, MD.PhD|