NCT05649618

TIL Cells for the Treatment of the Advanced Solid Tumors Patients

A Single-center, Open-label Clinical Study of TIL Cells for the Treatment of the Recurrent/Metastatic Solid Tumors Patients Who Had Failed Standard Therapy

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Fujian Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TILs) therapy in patients with Advanced malignant solid tumors. TILs are expanded from tumor resections or biopsies, and after ex vivo stimulation, activation and extensive expansion, are reinfused to patients after non-myeloablative lymphocyte-depleting preparative regimen.

Detailed description

This is a single-center, open-label, Phase I clinical study of TILs for the treatment of the recurrent/metastatic solid tumors patients who had failed standard therapy. TILs are expanded from tumor resections or biopsies, and after ex vivo stimulation, activation and extensive expansion, are reinfused to patients after non-myeloablative lymphocyte-depleting preparative regimen. The primary purpose of this study is to evaluate the safety and tolerability of TILs in patients with recurrent/metastatic solid tumors. The second purpose of this study is to preliminarily explore the effectiveness of TILs in patients with recurrent/metastatic solid tumors. Eligibility: Adults aging 18-75 who were failed to standard treatment or have no standard treatment with recurrent/metastatic solid tumors.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	Tumor Infiltrating Lymphocytes	On day 0 patients will be intravenous infusion of TILs
DRUG	Fludarabine	Part of the non-myeloablative lymphocyte-depleting preparative regimen
DRUG	Cyclophosphamide Capsules	Part of the non-myeloablative lymphocyte-depleting preparative regimen.
DRUG	IL-2	Following cell infusion, the patient receives high-dose bolus IL-2, which is dosed to individual patient tolerance.

Timeline

• Start date: 2022-12-05
• Primary completion: 2024-03-01
• Completion: 2026-03-01
• First posted: 2022-12-14
• Last updated: 2022-12-14