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Adoptive Transfer Of Autologous Tumor-Infiltrating Lymphocytes in Solid Tumors

Solid Tumor, Adult Clinical Trial

Official title:
Phase Ib Study To Assess The Feasibility And Safety Of Adoptive Transfer Of Autologous Tumor-Infiltrating Lymphocytes In Advanced Solid Tumors

Clinical Trial 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.

Clinical Trial Description

The objective of the trial is to define the feasibility and safety of TIL-ACT in combination with low-dose irradiation (LDI) in patients with advanced or metastatic solid tumors. Study treatment will begin with intravenous (IV) non-myeloablative (NMA) lymphodepleting chemotherapy composed by fludarabine and cyclophosphamide. Both treatments will be started on the same day. Fludarabine will be administered for five days, and cyclophosphamide for two days. Low-dose irradiation (LDI) will be then administered once, to up to 20 measurable tumor lesions using tomotherapy. TIL infusion will be performed intravenously followed by high dose IL-2 administration every eight hours, for a maximum of eight doses. Supportive care will be given as needed during the whole treatment period. Patients achieving a stable disease, partial response or complete response after TIL-ACT treatment will then enter a follow-up period for 5 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03992326
Study type Interventional
Source Centre Hospitalier Universitaire Vaudois
Contact
Status Terminated
Phase Phase 1
Start date September 1, 2019
Completion date March 5, 2021
View Details
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