Clinical Trials

Date: 2011-06-13

Type of information: Initiation of the trial

phase: 1-2

Announcement: initiation

Company: Adaptimmune (UK)

Product: NY-ESO-1c259-T cell therapy product

Action mechanism: cell therapy

Disease: metastatic melanoma

Therapeutic area: Cancer - Oncology

Country: USA

Trial details:

The clinical trial design includes patients who have unresectable stage III/IV melanoma. Up to 12 patients will be enrolled in the trial over a period of two years, with six patients participating in each of the NYESO-1 and MAGE-A3/6 cohorts in accordance with a genetic randomization scheme based on a patient’s HLA-A type and tumor antigen status. Patients enrolled on the study will have their T cells collected by leukapheresis, a procedure for collection of white blood cells. Once the manufacture of the genetically modified T cell product is complete, the patient will undergo cytoreductive chemotherapy to “make space” for the T cell infusion, followed a few days later with the infusion. The active phase of the study lasts three months, with up to one year of monitoring of patients responding to the treatment. (NCT01350401)

Latest news:

Adaptimmune has opened a Phase I/II, two cohort, open label clinical trial in metastatic melanoma at Washington University , St. Louis , Missouri. Adaptimmune is focused on the use of T-cell therapy to treat cancer, with the body’s own machinery - the T lymphocyte-- a cell that is being used to target and destroy cancerous cells. This trial is designed to investigate the safety, bioactivity and anti-tumor effect of patients’ own T cells that have been genetically modified to express a high affinity T cell receptor (TCR) specific for a type of tumor antigen (protein) known as a cancer testis antigen (CT antigen). TCRs that have been developed using Adaptimmune’s unique TCR enhancement technology will be deployed to target two CT antigens called Mage-A3/6 and NYESO-1. T cell manufacturing will be performed at the Clinical Cell and Vaccine Production Facility at the Perelman School of Medicine at the University of Pennsylvania directed by Dr. Bruce Levine.