NCT05798546

Treatment of Advanced Solid Tumors With Neo-T(GI-NeoT-02)

The Safety,Tolerance and Efficacy of Neoantigen Targeting T Cells Suspension for Intravenous Infusion(Neo-T) to Advanced Solid Tumor

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: BGI, China · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the safety of Neo-T in the treatment of advanced solid tumors. The secondary objective of this study is to evaluate preliminarily the effect of Neo-T in the treatment of advanced solid tumors.

Detailed description

This is a single arm, open label and non-randomized clinical study with two parts. In Part A, 6 subjects with advanced solid tumors will be enrolled to assess the safety and explore maximum tolerated dose(MTD) or recommended dose of Neo-T. Depending on results in Part A, the study may proceed to Part B, where 15 subjects with advanced solid tumors will be enrolled to evaluate the effect of Neo-T.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	Neo-T	Patients will recive Neo-T iv on day 0. Three times of cell infusion with an interval of 7 days constitute a cycle,maximum four cycles of treatment for patients.
DRUG	Cyclophosphamide	Cyclophosphamide 500 mg/m2/day iv on day-5 for one day.
DRUG	Fludarabine	Fludarabine 25 mg/m2/day iv on day-5 and day-4 for two days.
DRUG	Interleukin-2	500,000IU/m2 SC,after each cell infusion,IL-2 will start within 24 hours and every 8-12 hours for up to 6 doses.

Timeline

• Start date: 2022-09-28
• Primary completion: 2023-09-01
• Completion: 2024-09-01
• First posted: 2023-04-04
• Last updated: 2023-04-04

Locations

1 site across 1 country: China