CT Antigen TCR-redirected T Cells for Ovarian Cancer.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01567891|
Recruitment Status : Active, not recruiting
First Posted : March 30, 2012
Results First Posted : January 3, 2019
Last Update Posted : January 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer||Biological: NYESO-1c259 T cells||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 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.|
|Actual Study Start Date :||July 9, 2013|
|Actual Primary Completion Date :||June 6, 2017|
|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.
- Adverse Events Related to Study Treatment [ Time Frame: Up to 12 months ]Number of Participants with Adverse Events related to study treatment
- Tumor Response [ Time Frame: Change from baseline, every 4 weeks until month 3 and then every 3 month until disease progression ]Number of participants with response as assessed by Immune-related Response Criteria (irRC)
- Peak Persistence of Modified T-cells in the Peripheral Blood [ Time Frame: Days: 1, 2-4, weeks 1 to 4, Week 8, 12 and Month 6, then every 3 months thereafter until progression then during LTFU ]Measurement of NY-ESO-1ᶜ²⁵⁹T cells in blood
- Determine Functional Properties and Phenotype of Modified T-cells From Peripheral Blood. [ Time Frame: Weeks 4 and 8 post T-cell infusion ]Percentage of CD4+pentamer+ or CD8+pentamer+ cells expressing LAG-3, PD-1, TIM-3 in the functionality of NY-ESO-1ᶜ²⁵⁹T cells in the manufactured product and post-treatment blood.
- Correlate NY-ESO-1 Expression in Tumor Tissue Before Treatment With Archival Tumor Tissue to Assess Impact of Therapy on Expression of NY-ESO-1 Protein [ Time Frame: Screening and at Baseline ]
NY-ESO-1 expression as determined by Histoscore (H score). Histoscore (0-300) represents the amount of NY-ESO-1 protein present in the tissue sample.
[1 × (% cells 1+) + 2 × (% cells 2+) + 3 × (% cells 3+)]
(It is not clearly established if NY-ESO-1 H score has an association with prognosis.)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|