NCT04643574

NeoTIL in Advanced Solid Tumors

Pilot Study to Assess the Feasibility, Safety and Efficacy of Adoptive Transfer of Autologous Tumor-Infiltrating Lymphocytes Enriched for Tumor Antigen Specificity (NeoTIL) in Advanced Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Centre Hospitalier Universitaire Vaudois · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Single center, single arm pilot trial to test the feasibility, safety and efficacy of NeoTIL-ACT combined with low-dose irradiation (LDI) in patients with advanced, recurrent or metastatic solid tumors. The trial is based on lymphodepleting chemotherapy followed by LDI, and then ACT utilizing ex vivo expanded TIL, enriched for tumor antigen specificity (NeoTIL), in combination with high dose Interleukin-2 (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, safety, and efficacy of NeoTIL-ACT in combination with LDI in patients with advanced, recurrent or metastatic solid tumors, as categorized in two molecularly defined cohorts. 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 from for five days, and cyclophosphamide ffor two days. Low-dose irradiation (LDI) will be administered once, to tumor lesions using tomotherapy. Patients will receive NeoTIL infusion intravenously followed by high dose IL-2 administration every eight hours, for a maximum of fourteen doses. Supportive care will be given as needed during the whole treatment period. Patients achieving a stable disease, partial response or complete response after NeoTIL-ACT treatment will then enter a clinical follow-up period for 5 years.

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
BIOLOGICAL	NeoTIL	Adoptive transfer of ex vivo expanded Autologous Tumor-Infiltrating Lymphocytes enriched for tumor antigen specificity (NeoTIL)
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 fourteen doses.
RADIATION	Radiotherapy	Low-dose irradiation (1Gy) will be administered using tomotherapy to tumor lesions once before NeoTIL infusion.

Timeline

• Start date: 2021-03-09
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2020-11-25
• Last updated: 2025-02-14

Locations

1 site across 1 country: Switzerland