CT Antigen TCR-redirected T Cells for Ovarian Cancer.
|ClinicalTrials.gov Identifier: NCT01567891|
Recruitment Status : Active, not recruiting
First Posted : March 30, 2012
Last Update Posted : January 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Biological: NYESO-1c259 T cells||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/IIa, Open Label Clinical Trial Evaluating the Safety and Efficacy of Autologous T Cells Expressing Enhanced TCRs Specific for NY-ESO-1 in Patients With Recurrent or Treatment Refractory Ovarian Cancer.|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||January 2019|
Experimental: Cohort 1
This is an open label clinical trial. Patients with the HLA-A201, HLA-A205, and/or HLA-A206 allele and whose tumor expresses the NY-ESO-1 tumor antigen will be eligible to receive NYESO-1c259 T cells.
Biological: NYESO-1c259 T cells
Cytoreductive chemotherapy followed by infusion with NYESO-1(C259) transduced autologous T cells. Patients will receive at least 1x10⁹ transduced cells, however the target dose for this protocol is for patients to receive 5x10⁹ transduced cells with a maximum possible dose of 6x10⁹ administered as a single intravenous (IV) infusion.
- NCI CTC V.4 Adverse Events related to study treatment greater than or equal to Grade 3 [ Time Frame: At apheresis: Day -30 (±10 days) until month disease progression, LTFU (Years 1-15) ]To determine the safety and tolerability of autologous redirected T cell therapy in patients with treatment refractory or resistant Stage III/IV ovarian cancer.
- Tumor Response [ Time Frame: Baseline, Day 28, 8 weeks and at Months 3, 6, and every 3 months until disease progression, LTFU (Years 1-15) ]Evaluate correlates of treatment efficacy by measuring 1) Clinical response rates to treatment based on irRC and progression free survival, 2) to evaluate the persistence of genetically modified cells in the peripheral blood, and as possible at tumor sites, and 3) to evaluate the phenotype and functionality of genetically modified cells isolated from peripheral blood and, as possible, from tumor sites post infusion.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01567891
|United States, California|
|City of Hope National Medical Center|
|Duarte, California, United States, 91010|
|Stanford Cancer Institute|
|Stanford, California, United States, 94305|
|United States, Florida|
|University of Miami, Sylvester Comprehensive Cancer Center|
|Miami, Florida, United States, 33136|
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Kunle Odunsi, MD, PhD||Roswell Park Cancer Institute|