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

NCT05864924 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2024-05-08

No results posted yet for this study

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.

Conditions

  • EBV-positive Nasopharyngeal Carcinoma

Interventions

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

Sponsors & Collaborators

  • BioSyngen Pte Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-10
Primary Completion
2024-04-26
Completion
2024-04-26
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05864924 on ClinicalTrials.gov