Phase I/II Study to Assess the Safety and Activity of Enhanced TCR Transduced Autologous T Cells in Metastatic Melanoma
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Melanoma
- Sponsor
- Adaptimmune
- Enrollment
- 4
- Locations
- 2
- Primary Endpoint
- Adverse Events Related to Study Treatment
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Adverse Events Related to Study Treatment
Time Frame: 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 Outcomes
- Determine the Functional Properties and Phenotype of Modified T-cells From Peripheral Blood and Tumor Sites.(8 Weeks post T-cell infusion)
- Tumor Response(Change from Baseline, every 4 weeks until Month 5 and then every other month through Month 11)
- 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)