Date: 2017-06-05
Type of
information: Presentation of results at a congress
phase: 1
Announcement: presentation of results at the American Society of Clinical Oncology (ASCO) annual meeting, in Chicago
Company: Adaptimmune (UK)
Product: NY-ESO SPEAR® T-cell therapy
Action
mechanism: cell therapy/gene therapy/immunotherapy product
Disease: myxoid round cell liposarcoma
Therapeutic
area: Cancer - Oncology
Country: USA
Trial
details:
- This study is for men and women who have a type of sarcoma that has returned after being treated, or that cannot be surgically removed. The specific type of sarcoma is Myxoid / Round Cell Liposarcoma, also known as High Grade Myxoid Liposarcoma. In addition to this disease patients must also have the tissue type HLA-A*02:01, HLA-A*02:05 or HLA-A*02:06, and a sample of tumor tissue must test positive for the NY-ESO-1 protein.
- The study treatment is made from some of the patient's own white blood cells called T cells. T cells are collected from the patient and sent to a laboratory to be genetically modified, with the aim that they will be able to destroy the cancer cells.
- Manufacturing the T cells takes about 1 month to complete. The T cells will be given back to the patient by an intravenous infusion. The purpose of this study is to test whether the T cells have an effect on the cancer and to test whether the treatment can be given safely to patients with this disease. (NCT02992743)
Latest
news:
- • On June 5, 2017, Adaptimmune announced a poster presentation on trial progress of NY-ESO SPEAR T-cells in myxoid round cell liposarcoma at the American Society of Clinical Oncology (ASCO) Annual Meeting. Initially, 10 subjects are planned to be enrolled, with potential to enroll an additional 5 subjects. Subjects who do not receive the minimum cell dose or who do not receive the T-cell infusion may be replaced. Subjects must be: = 18 yrs old; HLA-A*02:01, *02:05, or *02:06 positive; have advanced (metastatic or inoperable) MRCLS expressing NY-ESO-1 at 2+/3+ intensity in =30% of tumor cells by IHC; measurable disease; prior systemic anthracycline therapy; have ECOG status 0 or 1; and adequate organ function.
Lymphodepletion regimen: fludarabine (30mg/m2/day) and cyclophosphamide (600 mg/m2/day) for 3 days.
Target dose of 1 – 8 × 109 transduced SPEAR T-cells.
Efficacy assessed by overall response rate, time to response, duration of response, progression-free survival, and overall survival at weeks 4, 8, and 12, month 6, and then every 3 months until confirmation of disease progression
This study is open and actively enrolling; as of May 18, 2017, 3 subjects have been enrolled.
- • On August 3, 2016, Adaptimmune Therapeutics announced that it has received notice from the FDA that a partial clinical hold has been placed on its planned pivotal study of NY-ESO SPEAR® T-cell therapy in myxoid round cell liposarcoma (MRCLS). This trial is not yet active at any investigational sites, and has not recruited any patients. This notification of partial clinical hold does not apply to any other Adaptimmune study. The FDA notification is not based on safety concerns. In its correspondence, the FDA requested additional CMC information and answers to certain trial design questions prior to the trial start. Adaptimmune intends to provide a full response to the FDA shortly.
Is
general: Yes
