drugset / Trial / NCT00078546
EBV-Specific CTLs Following CD45 Antibody to Patients With Epstein-Barr Virus (EBV) + Nasopharyngeal Carcinoma (NPC)
Phase 1
Completed
12 enrolled
Baylor College of Medicine
Center for Cell and Gene Therapy, Baylor College of Medicine · collabThe Methodist Hospital Research Institute · collab
NaSingle-groupOpen-labelTreatment
Summary
To determine the safety of the combination of CD45 monoclonal antibody (Mab) followed by intravenous injection of EBV specific CTL in patients with nasopharyngeal cancer. To compare the expansion, persistence and anti-tumor effects of the EBV specific CTL given after CD45 Mab administration with that observed in our first study. To obtain preliminary information on the safety and response to an extended dosage regimen of EBV-specific CTL in patients, who have stable disease or a partial response after the initial dose of EBV-specific CTL.
Timeline
- Start
- 2003-09
- Primary completion
- 2007-01
- Completion
- 2007-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Anti-CD45 | Protein / enzyme biologic | 400 ug/kg | Intravenous |
| Subject | EBV-specific CTL | Cell therapy | 2e+07 unknown | Intravenous |
| Subject | EBV-specific CTL | Cell therapy | 5e+07 unknown | Intravenous |
| Subject | EBV-specific CTL | Cell therapy | 1e+08 unknown | Intravenous |