Trials / Terminated
TerminatedNCT01350401
Phase I/II Study to Assess the Safety and Activity of Enhanced TCR Transduced Autologous T Cells in Metastatic Melanoma
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- Adaptimmune · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | Autologous genetically modified T cells, NY-ESO-1ᶜ²⁵⁹T | Cytoreductive chemotherapy followed by infusion of NY-ESO-1ᶜ²⁵⁹T |
Timeline
- Start date
- 2011-06-01
- Primary completion
- 2016-02-17
- Completion
- 2018-03-01
- First posted
- 2011-05-09
- Last updated
- 2019-01-10
- Results posted
- 2018-05-08
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01350401. Inclusion in this directory is not an endorsement.