Phase I/II Study to Assess the Safety and Activity of Enhanced TCR Transduced Autologous T Cells in Metastatic Melanoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01350401|
Recruitment Status : Active, not recruiting
First Posted : May 9, 2011
Last Update Posted : October 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Biological: NY-ESO-1||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study to Assess the Safety and Activity of Enhanced TCR Transduced Autologous T Cells in Metastatic Melanoma|
|Study Start Date :||May 2011|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||May 2031|
Subject's tumor must express cancer testis antigen NYESO-1 and be HLA-A*02 positive
Cytoreductive chemotherapy followed by infusion with NYESO-1(C259) transduced autologous T cells
- NCI CTC V.4 Adverse Events related to study treatment greater than or equal to Grade 3 [ Time Frame: Daily monitoring from Day1-Day 16, weekly thereafter through week 12, monthly thereafter through month 12. ]Determine the safety and tolerability of a fixed split-dose of autologous t cells transduced with lentiviral vector encoding an enhanced TCR after non-myeloablative chemotherapy.
- Tumor Response [ Time Frame: Baseline, every 4 weeks until month 5 and then every other month through month 11 ]Clinical Activity of TCR gene therapy as assessed by RECIST (version 1.1) criteria and progression-free survival
- Persistence of modified T cells in the peripheral blood [ Time Frame: Days: 1, 5-9, 12-16, weekly thereafter through week 12, monthly thereafter through month 12, and during LTFU ]To determine the persistence of modified T cells in the peripheral blood and at tumor sites.
- T cell function [ Time Frame: Weeks 4 and 8 post T cell infusion ]To determine the functional properties and phenotype of modified T cells from peripheral blood and tumor sites. T cell function is essential to document the activity (or inactivity) of TCR positive T cells isolated from each patient at certain time points after adoptive transfer.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01350401
|United States, Connecticut|
|Yale School of Medicine|
|New Haven, Connecticut, United States, 06520|
|United States, Missouri|
|Washington University in St. Louis|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Gerald P Linette, MD, PhD||Washington University School of Medicine|
|Principal Investigator:||Harriet Kluger, MD||Yale New Haven Hospital|