NCT03992326

Adoptive Transfer Of Autologous Tumor-Infiltrating Lymphocytes in Solid Tumors

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Centre Hospitalier Universitaire Vaudois · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
OTHER	TIL	Adoptive transfer of Autologous Tumor-Infiltrating Lymphocytes
DRUG	Cyclophosphamide	Cyclophosphamide will be administered as an intravenous (IV) infusion for two days.
DRUG	Fludarabine	Fludarabine will be administered as an intravenous (IV) infusion for five days.
DRUG	Interleukin-2	After TIL infusion, IL-2 (optional) will be started as a bolus administration every eight hours, for a maximum of eight doses.
OTHER	Radiotherapy	Low-dose irradiation (1Gy) will be administered using tomotherapy to up to 20 measurable tumor lesions once before TIL infusion.

Timeline

• Start date: 2019-09-01
• Primary completion: 2021-03-05
• Completion: 2021-03-05
• First posted: 2019-06-20
• Last updated: 2021-03-18

Locations

1 site across 1 country: Switzerland