drugset
drugset / Trial / NCT00515957

Study of LMP1- and LMP2- Specific Cytotoxic T-Lymphocytes (CTL)

NCT00515957 ↗

Phase 1 Withdrawn Baylor College of Medicine Center for Cell and Gene Therapy, Baylor College of Medicine · collabThe Methodist Hospital Research Institute · collab
Non-randomizedSingle-groupOpen-labelTreatment

Summary

In this study NPC patient will receive 4 days of treatment with CD45 antibody followed by one dose of LMP1- and LMP2-CTL. From this, we can learn if treating the patient first with the CD45 antibody will also let LMP1- and LMP2-CTL we give grow better. In addition, we will find out, if LMP1- and LMP2-CTL are safe and have enhanced anti-tumor activity in comparison to standard EBV-CTL. This study aims to determine the safety of autologous LMP1- and LMP2- specific cytotoxic T-lymphocytes (CTL) in combination with CD45 monoclonal antibody (MAb) in patients with EBV-positive nasopharyngeal carcinoma (NPC). And to obtain information on the expansion, persistence and anti-tumor effects of autologous LMP1- and LMP-2 specific CTL given after lymphodepletion with CD45 MAb in patients with EBV-positive NPC.

Timeline

Start
2007-08
Primary completion
2010-08
Completion
2010-08

Drugs

EvaluationDrugModalityDoseRoute
Subject LMP1/2 CTLs Cell therapy 2e+07 unknown Intravenous
Subject LMP1/2 CTLs Cell therapy 1e+08 unknown Intravenous
Subject LMP1/2 CTLs Cell therapy 3e+08 unknown Intravenous
Subject LMP1/2 CTLs Cell therapy 1e+09 unknown Intravenous
Background YTH 24/54 Unknown 400 ug/kg Intravenous

Indications

nasopharyngeal carcinoma