NCT00925314

A Study of Transgenic Lymphocyte Immunization (TLI) Against Telomerase in Subjects With Stage III Melanoma

A Phase 2, Open-Label Evaluation of the Safety and Efficacy of CB-10-01, Transgenic Lymphocyte Immunization (TLI) Against Telomerase, as Adjuvant Therapy in Subjects With Stage III Melanoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Cosmo Bioscience · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety, efficacy, and immunological response to the study product, TLI, as an adjuvant therapy in subjects with Stage III Melanoma. Normal cells in the body have an established lifespan. Cancer cells on the other hand have the ability to continue to divide into new cells indefinitely. More than 85% of cancer has this ability because of an enzyme found in the cancer cell. The Investigational Product, Transgenic Lymphocyte Immunization (TLI), is aimed at helping the immune system target this enzyme found in most cancerous cells. Subjects who meet all inclusion and exclusion criteria will undergo a leukapheresis in which white blood cells will be collected and used to manufacture their own personal study product. Subjects will receive 3 infusions of TLI roughly 1 month apart and will be followed over a 2 year period with routine laboratory draws, computed tomography (CT) scans and physical exams.

Conditions

• Stage IIIB Skin Melanoma
• Stage IIIC Skin Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	CB-10-01 (Transgenic Lymphocyte Immunization)	1 Primary Infusion and 2 Booster Infusions

Timeline

• Start date: 2007-06-01
• Primary completion: 2011-07-01
• Completion: 2014-07-01
• First posted: 2009-06-22
• Last updated: 2012-02-13

Locations

5 sites across 1 country: United States