A Pilot Study of Genetically Engineered NY-ESO-1 Specific (c259) T Cells in HLA-A2+ Patients With Synovial Sarcoma
The purpose of this early (pilot) clinical trial is to test the effects (both good and bad) of chemotherapy and the NYESO T cells on patients with metastatic and recurrent synovial sarcoma.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Genetically Engineered NY-ESO-1 Specific (c259) T Cells in HLA-A2+ Patients With Synovial Sarcoma|
- Determine the response rate. [ Time Frame: Day 28, 60, 100, 180; Month 9, 12, then q6 months x 3 yrs ] [ Designated as safety issue: Yes ]To determine whether the administration of T cells genetically engineered to recognize a peptide derived from NY-ESO-1 in HLAA2+patients demonstrate a response rate consistent with that observed using similar NYESO-1 specific T cells plus aldesleukin in patients with synovial sarcoma.
- Evaluate persistence and expansion of NY-ESO-1 cells [ Time Frame: Daily Days 0-14, D21, D28, D42, D60, Mo: 3, 4, 5, 6, 9, 12; q6mo for 3 yrs ] [ Designated as safety issue: No ]Evaluate persistence and expansion of adoptively transferred NY-ESO-1 (c259) cells and correlate this with clinical responses; Monitor Tregs in the adoptively transferred cells and in patients treated, and compare clinical outcomes with Treg levels; and When possible, assess whether patients with progressive disease following NY-ESO-1 T cells experience a response following a second dose administered with aldesleukin.
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||March 2029|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Experimental: NY-ESO-1 T cell Infusion
NIH population: Subjects age between ages 4 to 35 will receive one infusion of NY-ESO-1 genetically engineered T cells on Day 0.
CHOP population: Subjects age between ages 4 to 35 will receive one infusion of NY-ESO-1 genetically engineered T cells on Day 0.
Biological: NY-ESO-1 T Cells
Cytoreductive chemotherapy followed by infusion with NYESO-1(C259) transduced autologous T cells. Subjects will receive one infusion of NY-ESO-1 genetically engineered T cells on Day 0
- Patients will undergo apheresis at the enrolling institution. Fresh PBMC will be shipped to University of Pennsylvania and shipped back to the enrolling institution.
- Patients will undergo lymphodepletion with denileukin diftitox, fludarabine and cyclophosphamide, then infusion of NY-ESO-1 genetically engineered T cells on Day 0.
- Patients will be monitored for toxicity, antitumor effects and immune endpoints.
- Patients with a PR or SD may receive a 2nd cycle no earlier than 60 days following completion of the first cycle if eligibility criteria are met. For patients with progressive disease, a 2nd cycle that includes high dose aldesleukin administered beginning on the day of T cell infusion may be administered no earlier than 60 days following completion of the first cycle if eligibility criteria are met.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01343043
|Contact: Crystal Mackall, MDemail@example.com|
|Contact: Melinda Merchant, MDfirstname.lastname@example.org|
|United States, Maryland|
|Bethesda, Maryland, United States, 20852|
|Contact: Crystal Mackall, MD 301-402-5940 email@example.com|
|Contact: Melinda Merchant, MD, PhD 301-443-7955 firstname.lastname@example.org|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Christine Strait, BS 267-425-5837 email@example.com|
|Principal Investigator: Stephan Grupp, MD, PhD|
|Principal Investigator:||Crystal Mackall, MD||National Institutes of Health (NIH)|
|Principal Investigator:||Stephan Grupp, MD, PhD||Children's Hospital of Philadelphia|