NCT03658785

Immunotherapy for the Treatment of Advanced Solid Tumor

Immunotherapy Using Precision T Cells Specific to Personalized Neo-antigen for the Treatment of Advanced Solid Tumor

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, side effects and benefits of autologous tumor infiltrating lymphocytes (TIL) specific to personalized Neo-antigens in the treatment of patients with recurrent, metastatic and advanced solid tumors.

Detailed description

Adoptive cell transfer therapy that utilizes an autologous TIL manufacturing progress is originally developed by the NCI for the treatment of patients with recurrent, metastatic cervical cancer and liver cancer. TILs specific to personalized neo-antigens will be expended in vitro and given back to the patients through vein. A total of 20 patients will be enrolled in the single-arm, open label, interventional study.

Conditions

• Recurrence Tumor
• Metastatic Cancer
• Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	TIL	On day 0, cells will be infused intravenously over 20 to 30 minutes (one to four days after the last dose of fludarabine)
DRUG	Aldesleukin	IL-2 125,000 IU/kg/day IV (based on total body weight) beginning within 24 hours of cell infusion and continuing for up to 2 weeks
DRUG	Cyclophosphamide	On day -7 and day -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
DRUG	Fludarabine	Days -5 to -1: Fludarabine 25 mg /m2/day IVPB daily over 30 minutes for 5 days

Timeline

• Start date: 2020-04-28
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2018-09-05
• Last updated: 2024-08-13

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study