NCT05417750

A Phase I Study of GC101 TIL in Advanced Solid Tumors

An Open-label, Single-arm, Phase I Study to Evaluate the Safety and Efficacy of Autologous Tumor Infiltrating Lymphocytes Injection in Patients With Advanced Malignant Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Shanghai Juncell Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

20-60 participants are expected to be enrolled for the Phase I clinical trial which is further divided into two parts: a "3+3" dose escalation study and an expanded enrollment study. The Phase I clinical trial is expected to be finished in 36 months. To be specific, the dose escalation study plans to include patients with advanced malignant solid tumors with clear pathological diagnosis, including melanoma, cervical cancer, head and neck squamous cell tumors, non-small cell lung cancer and breast cancer, etc.; while the expanded enrollment study plans to include those with melanoma, cervical cancer, and head and neck squamous cell tumors.

Conditions

• Tumor Infiltrating Lymphocytes
• Safety
• Advanced Solid Tumor
• Immunotherapy
• Efficacy
• Adverse Drug Event

Interventions

Type	Name	Description
DRUG	TIL therapy	A tumor sample is resected from each participant and cultured ex vivo to expand the population of autologous tumor infiltrating lymphocytes injection (GC101 TIL). After lymphodepletion, patients are infused GC101 TIL followed sintilimab.

Timeline

• Start date: 2022-10-12
• Primary completion: 2025-04-30
• Completion: 2025-10-30
• First posted: 2022-06-14
• Last updated: 2025-12-10

Locations

1 site across 1 country: China