Gene-Modified T Cells With or Without Decitabine in Treating Patients With Advanced Malignancies Expressing NY-ESO-1
Public ClinicalTrials.gov record NCT02650986. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I/IIa Study of TGFß Blockade in TCR-Engineered T-Cell Cancer Immunotherapy in Patients With Advanced Malignancies
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This phase I/IIa trial studies the side effects and best dose of gene-modified T cells when given with or without decitabine, and to see how well they work in treating patients with malignancies expressing cancer-testis antigens 1 (NY-ESO-1) gene that have spread to other places in the body (advanced). A T cell is a type of immune cell that can recognize and kill abnormal cells of the body. Placing a modified gene for NY-ESO-1 into the patients' T cells in the laboratory and then giving them back to the patient may help the body build an immune response to kill tumor cells that express NY-ESO-1. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving gene-modified T cells with or without decitabine works better in treating patients with malignancies expressing NY-ESO-1.
Study identification
- NCT ID
- NCT02650986
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 15 participants
Conditions and interventions
Conditions
- Advanced Fallopian Tube Carcinoma
- Advanced Malignant Solid Neoplasm
- Advanced Melanoma
- Advanced Ovarian Carcinoma
- Advanced Primary Peritoneal Carcinoma
- Advanced Synovial Sarcoma
- Clinical Stage III Cutaneous Melanoma AJCC v8
- Clinical Stage IV Cutaneous Melanoma AJCC v8
- Metastatic Fallopian Tube Carcinoma
- Metastatic Melanoma
- Metastatic Ovarian Carcinoma
- Metastatic Primary Peritoneal Carcinoma
- Metastatic Synovial Sarcoma
- Pathologic Stage III Cutaneous Melanoma AJCC v8
- Pathologic Stage IIIA Cutaneous Melanoma AJCC v8
- Pathologic Stage IIIB Cutaneous Melanoma AJCC v8
- Pathologic Stage IIIC Cutaneous Melanoma AJCC v8
- Pathologic Stage IIID Cutaneous Melanoma AJCC v8
- Pathologic Stage IV Cutaneous Melanoma AJCC v8
- Platinum-Resistant Fallopian Tube Carcinoma
- Platinum-Resistant Ovarian Carcinoma
- Platinum-Resistant Primary Peritoneal Carcinoma
- Stage III Fallopian Tube Cancer AJCC v8
- Stage III Ovarian Cancer AJCC v8
- Stage III Primary Peritoneal Cancer AJCC v8
- Stage IIIA Fallopian Tube Cancer AJCC v8
- Stage IIIA Ovarian Cancer AJCC v8
- Stage IIIA Primary Peritoneal Cancer AJCC v8
- Stage IIIA1 Fallopian Tube Cancer AJCC v8
- Stage IIIA1 Ovarian Cancer AJCC v8
- Stage IIIA2 Fallopian Tube Cancer AJCC v8
- Stage IIIA2 Ovarian Cancer AJCC v8
- Stage IIIB Fallopian Tube Cancer AJCC v8
- Stage IIIB Ovarian Cancer AJCC v8
- Stage IIIB Primary Peritoneal Cancer AJCC v8
- Stage IIIC Fallopian Tube Cancer AJCC v8
- Stage IIIC Ovarian Cancer AJCC v8
- Stage IIIC Primary Peritoneal Cancer AJCC v8
- Stage IV Fallopian Tube Cancer AJCC v8
- Stage IV Ovarian Cancer AJCC v8
- Stage IV Primary Peritoneal Cancer AJCC v8
- Stage IVA Fallopian Tube Cancer AJCC v8
- Stage IVA Ovarian Cancer AJCC v8
- Stage IVA Primary Peritoneal Cancer AJCC v8
- Stage IVB Fallopian Tube Cancer AJCC v8
- Stage IVB Ovarian Cancer AJCC v8
- Stage IVB Primary Peritoneal Cancer AJCC v8
- Unresectable Melanoma
- Unresectable Ovarian Carcinoma
- Unresectable Synovial Sarcoma
Interventions
- Cyclophosphamide Drug
- Decitabine Drug
- Laboratory Biomarker Analysis Other
- Leukapheresis Procedure
- TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes Biological
Drug · Other · Procedure + 1 more
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 13, 2017
- Primary completion
- Mar 3, 2021
- Completion
- Jul 13, 2032
- Last update posted
- Jul 7, 2026
2017 – 2032
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02650986, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 7, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02650986 live on ClinicalTrials.gov.