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

NCT00515957 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2012-04-16

No results posted yet for this study

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.

Conditions

  • NASOPHARYNGEAL CARCINOMA

Interventions

GENETIC

genetically modified CTLs in combo with CD45 antibodies

LMP1- and LMP2- specific cytotoxic T-lymphocytes (CTL) in combination with CD45 monoclonal antibody (MAb). --Infusions of CD45 MAbs: A fixed dose of CD45 MAbs will be used determined from our previous and ongoing studies in stem cell transplant recipients will be used43, 400ug/kg over 6 to 8 hrs daily x 4 given as 4 daily intravenous infusions that will be completed 48-72 hours prior to CTL infusion. Day 1 YTH 24/54 400ug/kg over 6 to 8 hr 2 YTH 24/54 400ug/kg over 6 to 8 hr 3 YTH 24/54 400ug/kg over 6 to 8 hr 4 YTH 24/54 400ug/kg over 6 to 8 hr 5 Rest 6-8 CTL Infusion (provided CD45 MAb level \<100 ng/ml) --LMP1- and LMP2-specific T cells will be given by intravenous injection over 1-10 minutes through either a peripheral or a central line. 2x 10\^7 cells/m2 1x 10\^8 cells/m2 3 x 10\^8 cells/m2 1 x 10\^9 cells/m2

Sponsors & Collaborators

  • The Methodist Hospital Research Institute

    collaborator OTHER

  • Center for Cell and Gene Therapy, Baylor College of Medicine

    collaborator OTHER

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Stephen Gottschalk, MD · Baylor College of Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2010-08-31
Completion
2010-08-31

More Related Trials

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 NCT00515957 on ClinicalTrials.gov