Date: 2017-06-05
Type of
information: Presentation of results at a congress
phase: 1-2
Announcement: presentation of results at the American Society of Clinical Oncology (ASCO) annual meeting, in Chicago
Company: Adaptimmune (UK)
Product: NY-ESO1c259T cell therapy product
Action
mechanism: cell therapy/gene therapy/immunotherapy product
Disease: non-small cell lung cancer (NSCLC)
Therapeutic
area: Cancer - Oncology
Country: USA
Trial
details:
- The phase I/II open label clinical trial is intended for men and women at least 18 years of age who have advanced lung cancer which has grown or returned after being treated. In particular, it is a study for subjects who have a blood test positive for HLA-A*0201, HLA-A*205 and/or HLA-A*0206 protein and a tumor test positive for NY-ESO-1 expression (protein or gene). The study will take the subject's T cells, which are a natural type of immune cell in the blood, and send them to a laboratory to be modified. The changed T cells used in this study will be the subject's own T cells that have been genetically changed with the aim of attacking and destroying cancer cells. The manufacturing of T cells takes about 1 month to complete. The T cells will be given back to the subject through an intravenous infusion. The purpose of this study is to test the safety of genetically changed T cells and find out what effects, if any, they have in subjects with lung cancer. Subjects will be seen frequently by the Study Physician right after receiving their T cells back. Subjects will then be entered into a long-term follow up in order to monitor the subject. Subjects will be seen every 6 months by their Study Physician for the first 5 years after the T cell infusion. If the T cells are found in the blood at five years, then the subjects will continue to be seen once a year until the T cells are no longer found in the blood for a maximum of 15 years. If the T cells are no longer found in the blood at 5 years, then the subject will be contacted by the Study Physician for the next 10 years. (NCT02588612)
Latest
news:
- • On June 5, 2017, Adaptimmune announced the presentation of a progress poster from open-label study of NY-ESO SPEAR T-cells in patients with non-small cell lung cancer (NSCLC). The NY-ESO trial is a 10 subject study with a target dose of 1-6 x109transduced cells. For this study, the lymphodepletion regimen is: fludarabine (30mg/m2/day) and cyclophosphamide (600 mg/m2/day) for 3 days. Efficacy assessed by response rate, duration of response, progression-free survival, and overall survival at weeks 4, 8, and 12, month 6, and then every 3 months (for 2 years) and then every 6 months until confirmation of disease progression
The study is currently active and enrolling; as of May 18, 2017, 3 subjects have been enrolled in the NY-ESO-1 study.
- • On November 24, 2015, Adaptimmune announced that it has initiated a study of its affinity enhanced T-cell therapy targeting the NY-ESO-1 cancer antigen in patients with Stage IIIb or Stage IV non-small cell lung cancer. Adaptimmune is developing the affinity enhanced T-cell therapy targeting NY-ESO-1 under a collaboration agreement with GSK. This is an open label clinical study in up to 10 patients with locally advanced or metastatic non-small cell lung cancer and whose disease has progressed or not responded to prior therapies. The company expects to begin dosing of patients shortly. Patients with the HLA-A*0201, HLA-A*0205, and/or HLA-A*0206 allele, whose tumor expresses the NY-ESO-1 tumor antigen, and who meet study entry criteria will be eligible to receive a single dose of autologous genetically modified T-cells expressing affinity optimized TCRs specific for NY-ESO-1. Though the prevalence of HLA sub-types varies from population to population, the most common in the western world is HLA-A2. Among the HLA-A2 variants, the most prevalent are HLA-A*0201 and HLA-A*0206. The primary objective of this study is to evaluate the safety and tolerability of Adaptimmune’s affinity enhanced T-cell therapy targeting NY-ESO in HLA-A*0201, HLA-A*0205 and/or HLA-A*0206 positive patients with NY-ESO-1 positive advanced non-small cell lung cancer. Secondary objectives include evaluation of efficacy in these patients, measurement of persistence of genetically modified cells in the body, and evaluations of the phenotype and functionality of genetically modified cells isolated from peripheral blood or tumor post infusion.
Is
general: Yes
