Phase I/II Study to Assess the Safety and Activity of Enhanced TCR Transduced Autologous T Cells in Metastatic Melanoma
- Conditions
- Melanoma
- Interventions
- Genetic: Autologous genetically modified T cells, NY-ESO-1ᶜ²⁵⁹T
- Registration Number
- NCT01350401
- Lead Sponsor
- Adaptimmune
- Brief Summary
The purpose of this early (phase I/II) clinical trial is to assess the effects (both good and bad) of genetically modified T cells after chemotherapy on your cancer and general health.
- Detailed Description
Purpose of this study is to evaluate the safety and tolerability of autologous genetically modified T cells. Genetic material is transferred into the subject's previously harvested autologous T cells to redirect them to target melanoma cells rather than their usual target. Study subjects must have histologically or cytologically melanoma stage 3/4 and their tumor must express HLA Class 1 allele HLA-A\*0201 for NY-ESO-1/LAGE. Subjects must also have measureable disease on study entry, as defined by at least one lesion that can be measured in at least one dimension \>= 10mm with spiral CT scan.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description NY-ESO-1/LAGE-1 and HLA-A*02 Positive Subjects Autologous genetically modified T cells, NY-ESO-1ᶜ²⁵⁹T -
- Primary Outcome Measures
Name Time Method Adverse Events Related to Study Treatment Up to 12 months Number of Participants with NCI CTC V.4 Adverse Events related to study treatment greater than or equal to Grade 3
- Secondary Outcome Measures
Name Time Method Determine the Functional Properties and Phenotype of Modified T-cells From Peripheral Blood and Tumor Sites. 8 Weeks post T-cell infusion Measurement of functionality of NY-ESO-1ᶜ²⁵⁹T cells in the blood and tumor sites.
Tumor Response Change from Baseline, every 4 weeks until Month 5 and then every other month through Month 11 Number of participants with response as assessed by RECIST (version 1.1) criteria.
Peak Persistence of Modified T-cells in the Peripheral Blood Days 1, 5-9, 12-16, weekly thereafter through Week 12, monthly thereafter through Month 12, and during LTFU Measurement of NY-ESO-1ᶜ²⁵⁹T cells in blood (copies of WPRE per µg of genomic PBMC DNA)
Trial Locations
- Locations (2)
Yale School of Medicine
🇺🇸New Haven, Connecticut, United States
Washington University in St. Louis
🇺🇸Saint Louis, Missouri, United States