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NOT YET RECRUITING
NCT07389239
PHASE1/PHASE2

A Study Evaluating the Immunotherapy Treatment for Ovarian Cancer and Other Advanced Malignancies.

Sponsor: University of Chicago

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.

Official title: A Phase I/IIA Study Evaluating the Safety and Efficacy of NY-ESO-1TCR/dnTGFBRII Engineered T Cells in Combination With Decitabine in Subjects With Recurrent or Treatment Refractory Ovarian Cancer and Other Advanced Malignancies

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2026-06-23

Completion Date

2031-12-10

Last Updated

2026-02-20

Healthy Volunteers

No

Interventions

DRUG

Decitabine

Decitabine taken by mouth 15 mg/m2/day x 5 days, IV; Days -10 to -6

DRUG

Cyclophosphamide Conditioning

Cyclophosphamide Conditioning will be 45 mg/kg x 2 days IV; Days -4 \& -3

BIOLOGICAL

NY-ESO-1 TCR/ dnTGFβRII

The dose of NY-ESO-1 TCR/ dnTGFβRII to be tested will vary depending on assigned arm.

DRUG

Aldesleukin

Aldesleukin taken by mouth500,000 IU/m2 SC BID; Days +1 to +10

Locations (1)

University of Chicago Medicine Comprehensive Cancer Center

Chicago, Illinois, United States