NCT05798533

Neo-T in Treating Patients With Advanced Solid Tumors(GI-NeoT-03)

The Neoantigen Targeting T Cells Suspension for Intravenous Infusion(Neo-T) in Treating Patients With Advanced Solid Tumor

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (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 combination with anti-PD1 in patients with solid tumors. The secondary objective of this study is to evaluate preliminarily the effect of Neo-T in combination with anti-PD1 in patients with solid tumors.

Detailed description

This is a single arm, open label and non-randomized clinical study. 6 to12 patients will be enrolled to assess the safety and explore recommended dose of Neo-T combined with anti-PD1.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	Neo-T	Patients will receive 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.
COMBINATION_PRODUCT	Toripalimab	3mg/kg iv; Within 7 days after the first PBMC collection (day-38±3), the first dose was administered, and thereafter every 2 weeks. Toripalimab is recommended for patients with Melanoma.
COMBINATION_PRODUCT	Tislelizumab	200mg iv; Within 7 days after the first PBMC collection (day-38±3), the first dose was administered, and thereafter every 3 weeks. Tislelizumab is recommended for patients with NSCLC or other tumor types.

Timeline

• Start date: 2023-01-10
• Primary completion: 2023-09-01
• Completion: 2024-09-01
• First posted: 2023-04-04
• Last updated: 2023-07-10

Locations

2 sites across 1 country: China