Clinical Trial: A Pilot Study of NY-ESO-1ᶜ²⁵⁹T Cells in Subjects With Advanced Myxoid/ Round Cell Liposarcoma
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Pilot Study of NY-ESO-1ᶜ²⁵⁹T Cells in Subjects With Advanced Myxoid/ Round Cell Liposarcoma
Brief Summary:
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.
Detailed Summary:
This is an open label pilot study of gene modified autologous T cells for the treatment of advanced myxoid/ round cell liposarcoma or high-grade myxoid liposarcoma.
Subjects with the HLA-A*02:01, HLA-A*02:05 and/or HLA-A*02:06 allele, whose tumor expresses the NY-ESO-1 antigen and who meet study entry criteria will be eligible for enrollment. Following enrollment, subjects will undergo leukapheresis for collection of autologous cells for processing and manufacture into the NY-ESO-1ᶜ²⁵⁹T cell investigational product.
Once the NY-ESO-1ᶜ²⁵⁹T cells have been manufactured subjects will receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide on Days -7 to -5 and NY-ESO-1ᶜ²⁵⁹T cells by a single intravenous infusion on Day 1. Dose range is 1 x 10⁹ - 8 x 10⁹ transduced cells. Subjects will complete the interventional phase of the study upon confirmation of disease progression.
Sponsor: Adaptimmune
Current Primary Outcome: Proportion of subjects with a confirmed Complete Response (CR) or Partial Response (PR). [ Time Frame: 1 Year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Interval between the date of first T cell infusion dose and first documented evidence of CR or PR. [ Time Frame: 1 Year ]Evaluation of the efficacy of the treatment by assessment of time to first response.
- Interval between the date of first documented evidence of CR or PR until first documented disease progression or death due to any cause. [ Time Frame: 1 Year ]Evaluation of the efficacy of the treatment by assessment of duration of response.
- Interval between the date of first documented evidence of SD until first documented disease progression or death due to any cause. [ Time Frame: 1 Year ]Evaluation of the efficacy of the treatment by assessment of duration of stable disease.
- Interval between the date of first T cell infusion and the earliest date of disease progression or death due to any cause. [ Time Frame: 1 Year ]Evaluation of the efficacy of the treatment by assessment of progression-free survival.
- Interval between the date of first T cell infusion and date of death due to any cause. [ Time Frame: 1 Year ]Evaluation of the efficacy of the treatment by assessment of overall survival.
- Number of subjects with adverse events (AE), including serious adverse events (SAE). [ Time Frame: 1 Year ]Determine if treatment with autologous genetically modified T cells (NY-ESO-1ᶜ²⁵⁹T) is safe and tolerable through laboratory assessments, including chemistry and hematology, and anti-NY-ESO-1 antibodies; and cardiac assessments, including ECG.
Original Secondary Outcome: Same as current
Information By: Adaptimmune
Dates:
Date Received: December 12, 2016
Date Started: November 2016
Date Completion:
Last Updated: April 27, 2017
Last Verified: April 2017