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ACTIVE NOT RECRUITING
NCT02650986
PHASE1/PHASE2

Gene-Modified T Cells With or Without Decitabine in Treating Patients With Advanced Malignancies Expressing NY-ESO-1

Sponsor: Roswell Park Cancer Institute

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase I/IIa Study of TGFß Blockade in TCR-Engineered T-Cell Cancer Immunotherapy in Patients With Advanced Malignancies

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2017-07-14

Completion Date

2032-07-14

Last Updated

2025-06-17

Healthy Volunteers

No

Conditions

Advanced Fallopian Tube CarcinomaAdvanced Malignant Solid NeoplasmAdvanced MelanomaAdvanced Ovarian CarcinomaAdvanced Primary Peritoneal CarcinomaAdvanced Synovial SarcomaClinical Stage III Cutaneous Melanoma AJCC v8Clinical Stage IV Cutaneous Melanoma AJCC v8Metastatic Fallopian Tube CarcinomaMetastatic MelanomaMetastatic Ovarian CarcinomaMetastatic Primary Peritoneal CarcinomaMetastatic Synovial SarcomaPathologic Stage III Cutaneous Melanoma AJCC v8Pathologic Stage IIIA Cutaneous Melanoma AJCC v8Pathologic Stage IIIB Cutaneous Melanoma AJCC v8Pathologic Stage IIIC Cutaneous Melanoma AJCC v8Pathologic Stage IIID Cutaneous Melanoma AJCC v8Pathologic Stage IV Cutaneous Melanoma AJCC v8Platinum-Resistant Fallopian Tube CarcinomaPlatinum-Resistant Ovarian CarcinomaPlatinum-Resistant Primary Peritoneal CarcinomaStage III Fallopian Tube Cancer AJCC v8Stage III Ovarian Cancer AJCC v8Stage III Primary Peritoneal Cancer AJCC v8Stage IIIA Fallopian Tube Cancer AJCC v8Stage IIIA Ovarian Cancer AJCC v8Stage IIIA Primary Peritoneal Cancer AJCC v8Stage IIIA1 Fallopian Tube Cancer AJCC v8Stage IIIA1 Ovarian Cancer AJCC v8Stage IIIA2 Fallopian Tube Cancer AJCC v8Stage IIIA2 Ovarian Cancer AJCC v8Stage IIIB Fallopian Tube Cancer AJCC v8Stage IIIB Ovarian Cancer AJCC v8Stage IIIB Primary Peritoneal Cancer AJCC v8Stage IIIC Fallopian Tube Cancer AJCC v8Stage IIIC Ovarian Cancer AJCC v8Stage IIIC Primary Peritoneal Cancer AJCC v8Stage IV Fallopian Tube Cancer AJCC v8Stage IV Ovarian Cancer AJCC v8Stage IV Primary Peritoneal Cancer AJCC v8Stage IVA Fallopian Tube Cancer AJCC v8Stage IVA Ovarian Cancer AJCC v8Stage IVA Primary Peritoneal Cancer AJCC v8Stage IVB Fallopian Tube Cancer AJCC v8Stage IVB Ovarian Cancer AJCC v8Stage IVB Primary Peritoneal Cancer AJCC v8Unresectable MelanomaUnresectable Ovarian CarcinomaUnresectable Synovial Sarcoma

Interventions

DRUG

Cyclophosphamide

Given IV

DRUG

Decitabine

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

PROCEDURE

Leukapheresis

Undergo leukapheresis

BIOLOGICAL

TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes

Given IV

Locations (1)

Roswell Park Cancer Institute

Buffalo, New York, United States