drugset / Trial / NCT03992326

Adoptive Transfer Of Autologous Tumor-Infiltrating Lymphocytes in Solid Tumors

NCT03992326 ↗

Phase 1 Terminated 6 enrolled Centre Hospitalier Universitaire Vaudois
NaSingle-groupOpen-labelTreatment

Summary

Single center, single arm phase Ib trial to test the feasibility and safety of Tumor- Infiltrating Lymphocyte-Adoptive Cell Therapy (TIL-ACT) combined with low-dose irradiation in patients with advanced or metastatic solid tumors. The trial is based on lymphodepleting chemotherapy followed by low dose irradiation (LDI), and then ACT utilizing ex vivo expanded TILs in combination with high dose IL-2 (optional, depending on patient's tolerance). LDI will be administered once to metastatic lesions using tomotherapy.

Timeline

Start
2019-09-01
Primary completion
2021-03-05
Completion
2021-03-05

Outcome

Outcome not reported

Stopped: “Internal competitive study that is open”

Drugs

EvaluationDrugModalityDoseRoute
Background Cyclophosphamide Other / unclassified — Intravenous
Background Fludarabine Small molecule — Intravenous
Background aldesleukin Protein / enzyme biologic — —

Indications