Cellular Immunotherapy Treatment Antigen-Directed for EBV Lymphoma
Research type
Research Study
Full title
A Phase 2 open label study to investigate the efficacy of autologous EBV-specific T-cells for the treatment of patients with aggressive Extranodal NK/T cell lymphoma (ENKTCL)
IRAS ID
142160
Contact name
Michelle Tricker
Contact email
Sponsor organisation
Cell Medica, Inc.
Eudract number
2013-004380-31
Research summary
This clinical study will evaluate the administration CMD-003 for the treatment of patients with aggressive Epstein-Barr virus - positive extranodal natural killer/T-cell lymphoma(ENKTCL).This rare tumour type is highly associated with Epstein-Barr virus (EBV). There is an unmet medical need for treatments for patients with Epstein-Barr virus (EBV)-positive aggressive extranodal natural killer/T-cell lymphoma (ENKTCL) due to the high mortality rates, short duration of expected survival, and lack of acceptable treatments.
Participants eligible for this study will be male or female over the age of 18. Participants will be monitored for safety and efficacy for 1 year after first CMD-003 dose administration. The study is expected to complete patient enrollment in 18 months, for a total study duration of 2.5 years from first patient in to last patient study visit.
The study comprises of a screening visit (Visit 1) and Treatment Visits up to Visit 10.
This study is being carried out at NHS sites.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
14/NW/1092
Date of REC Opinion
8 Sep 2014
REC opinion
Further Information Favourable Opinion