NCT04571892

A Clinical Study to Observe the Safety and Efficacy of ScTIL210 in the Treatment of Malignant Solid Tumors

An Open-label, Single-arm, Single-dose Escalation and Multiple-dose Expansion Clinical Study of Cell Therapy to Evaluate the Tolerance, the Pharmacokinetic Characteristics, the Safety, and the Efficacy of ScTIL210 in the Treatment of Malignant Solid Tumors

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Shanghai East Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

An open-label, single-arm, single-dose escalation and multiple-dose expansion clinical study of cell therapy to observe and to evaluate the tolerance, the pharmacokinetic characteristics, the safety, and the efficacy of ScTIL210 in the treatment of malignant

Conditions

• Malignant Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	Super circulating tumor infiltrating lymphocytes(ScTIL)	Peripheral blood mononuclear cells (PBMCs) are used for cell preparation. PD-1(programmed death 1) positive T cells are isolated from peripheral blood by blood cell apheresis method and transduced with lentivirus loaded with "enhanced receptor" and "superamplification factor". The obtained ScTIL is used for one-time intravenous infusion.

Timeline

• Start date: 2020-10-15
• Primary completion: 2023-12-01
• Completion: 2024-12-01
• First posted: 2020-10-01
• Last updated: 2023-04-12

Locations

2 sites across 1 country: China