EBV-TCR-T?YT-E001?for Patients With EBV-positive Recurrent or Metastatic NPC
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Nasopharyngeal Carcinoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Single arm, open label, single dose phase I/II study of safety and efficacy.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This Phase I/II study is designed as single dose pilot trial evaluating the safety and of EBV-TCR-TT cell therapy in subjects with NPC who have received prior therapy for their disease but the disease has progressed or relapsed. Anti-tumor activity and other exploratory objectives will be assessed. ...
This Phase I/II study is designed as single dose pilot trial evaluating the safety and of EBV-TCR-TT cell therapy in subjects with NPC who have received prior therapy for their disease but the disease has progressed or relapsed. Anti-tumor activity and other exploratory objectives will be assessed. Subjects enter from a Screening Protocol and are positive for HLA- A02:01/24:02/11:01, and EBV serum positive. Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -6 and -4 followed by infusion of dose of about 2×108 EBV-TCR-T(YT-E001). Subjects will stay in hospital for safety and efficacy assessment daily from T cell infusion (Day 0) through Day 7, and then weekly until week 4 and then at 8 weeks every 8 weeks until progression of their disease or the end or termination of trial.
Tracking Information
- NCT #
- NCT03648697
- Collaborators
- China Immunotech (Beijing) Biotechnology Co., Ltd.
- Investigators
- Not Provided
Get Well Soon