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

ClinicalTrials.gov ID: NCT00925314

Public ClinicalTrials.gov record NCT00925314. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT00925314
Recruitment status: Not listed
Study type: Interventional
Phase: Phase 2
Lead sponsor: Cosmo Bioscience; Industry
Enrollment: 20 participants

Conditions and interventions

Conditions

Interventions

CB-10-01 (Transgenic Lymphocyte Immunization) Biological

Biological

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: May 31, 2007
Primary completion: Jun 30, 2011
Completion: Jun 30, 2014
Last update posted: Feb 12, 2012

2007 – 2014

United States locations

U.S. sites: 5
U.S. states: 1
U.S. cities: 5

Facility	City	State	ZIP	Site status
City of Hope	Duarte	California	91010	—
University of California Los Angeles	Los Angeles	California	90024	—
University of California San Diego	San Diego	California	92093	—
Northern California Melanoma Center	San Francisco	California	94117	—
John Wayne Cancer Institute	Santa Monica	California	90404	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00925314, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Feb 12, 2012 · Synced Sep 5, 2026

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The complete protocol, eligibility criteria, and contact information for NCT00925314 live on ClinicalTrials.gov.

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