drugset / Trial / NCT01883297

"Re-Stimulated" TILs And IL-2 Therapy for Platinum Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

NCT01883297

Phase 1 Active not recruiting 3 enrolled University Health Network, Toronto
NaSingle-groupOpen-labelTreatment

Summary

This is a phase I clinical study for patients with platinum-resistant high grade serous ovarian, fallopian tube, or primary peritoneal cancer, and the response to a combination of cyclophosphamide, autologous tumor-infiltrating lymphocytes (TILs), autologous dendritic cells (DCs), and OKT3 (anti-CD3 antibody), along with low-dose interleukin-2 (IL-2) therapy.

Timeline

Start
2015-01
Primary completion
2027-06
Completion
2027-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Re-stimulated tumor-infiltrating lymphocytes (TILs) Cell therapy 3e+07 cells Intravenous
Subject Re-stimulated tumor-infiltrating lymphocytes (TILs) Cell therapy 1e+08 cells Intravenous
Subject Re-stimulated tumor-infiltrating lymphocytes (TILs) Cell therapy 3e+08 cells Intravenous
Subject aldesleukin Protein / enzyme biologic Subcutaneous
Background Cyclophosphamide Other / unclassified 30 mg/kg Intravenous