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 :
Completed
First Posted : May 18, 2023
Last Update Posted : May 8, 2024
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Tracking Information | |||||
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First Submitted Date ICMJE | April 27, 2023 | ||||
First Posted Date ICMJE | May 18, 2023 | ||||
Last Update Posted Date | May 8, 2024 | ||||
Actual Study Start Date ICMJE | May 10, 2023 | ||||
Actual Primary Completion Date | April 26, 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Phase 1 Study of BRG01 in Subjects With Relapsed/Metastatic Epstein-Barr Virus (EBV)-Positive Nasopharyngeal Carcinoma | ||||
Official Title ICMJE | A Phase 1 Study Evaluating the Safety and Efficacy of BRG01 in Subjects With Relapsed/Metastatic EBV-positive Nasopharyngeal Carcinoma | ||||
Brief 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. |
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Detailed Description | Primary Objective: To evaluate the safety and efficacy of BRG01. Secondary Objectives:
Exploratory Objectives:
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | EBV-positive Nasopharyngeal Carcinoma | ||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: BRG01 injection
Intravenous infusion
Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
14 | ||||
Original Estimated Enrollment ICMJE |
18 | ||||
Actual Study Completion Date ICMJE | April 26, 2024 | ||||
Actual Primary Completion Date | April 26, 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Complete Blood Count Neutrophils (NEUT#) ≥1.0x10^9/L; Platelet (PLT) ≥80x10^9/L; Hemoglobin ≥90g/L; Liver function: Without No liver metastasis Aspartate aminotransferase (AST) ≤2.5 x Upper Limit of Normal (ULN); Alanine aminotransferase (ALT) ≤2.5 x ULN; Total bilirubin (TBIL) ≤1.5 x ULN; Liver Function: With liver metastasis Aspartate aminotransferase (AST) ≤5 x ULN; Alanine aminotransferase (ALT) ≤5 x ULN; Liver Function: With liver metastasis or Gilbert syndrome; Total bilirubin (TBIL) ≤2 x ULN; Creatinine Clearance Rate (CCR) ≥ 50 mL/min; International Normalized Ratio (INR) ≤1.5xULN; Activated partial thromboplastin time (APTT) ≤1.5xULN; 12. During the study period and within 6 months after the end of administration, the subjects of childbearing potential (whether male or female) must use effective medical contraceptive measures For female subjects of childbearing age, a pregnancy test must be performed within 72 hours before cell infusion, and the result is negative. - Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05864924 | ||||
Other Study ID Numbers ICMJE | BIOSG-BRG-01 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | BioSyngen Pte Ltd | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | BioSyngen Pte Ltd | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | BioSyngen Pte Ltd | ||||
Verification Date | April 2023 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |