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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Cytoreductive chemotherapy followed by infusion of NY-ESO-1ᶜ²⁵⁹T
Yale School of Medicine
New Haven, Connecticut, United States
Washington University in St. Louis
St Louis, Missouri, United States
Adverse Events Related to Study Treatment
Number of Participants with NCI CTC V.4 Adverse Events related to study treatment greater than or equal to Grade 3
Time frame: Up to 12 months
Tumor Response
Number of participants with response as assessed by RECIST (version 1.1) criteria.
Time frame: Change from Baseline, every 4 weeks until Month 5 and then every other month through Month 11
Determine the Functional Properties and Phenotype of Modified T-cells From Peripheral Blood and Tumor Sites.
Measurement of functionality of NY-ESO-1ᶜ²⁵⁹T cells in the blood and tumor sites.
Time frame: 8 Weeks post T-cell infusion
Peak Persistence of Modified T-cells in the Peripheral Blood
Measurement of NY-ESO-1ᶜ²⁵⁹T cells in blood (copies of WPRE per µg of genomic PBMC DNA)
Time frame: Days 1, 5-9, 12-16, weekly thereafter through Week 12, monthly thereafter through Month 12, and during LTFU
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