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

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.

Eligibility

Age range

18+ years

Sex

All

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

Location