NCT07389239

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ovarian Cancer
• Advanced Malignant Solid Tumor

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-06-23
• Primary completion: 2031-12-10
• Completion: 2031-12-10
• First posted: 2026-02-05
• Last updated: 2026-02-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study