NCT07105176

HS-IT101 Injection for Advanced NSCLC

A Phase Ib Single-arm Clinical Study of HS-IT101 Injection for Advanced NSCLC

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Qingdao Sino-Cell Biomedicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

An Open-Label, Single-Arm Phase Ib Clinical Trial Evaluating the Safety, Tolerability, and Preliminary Efficacy of HS-IT101 Injection in Subjects with Advanced NSCLC.

Detailed description

A Single-Arm, Open-Label, Interventional Study Evaluating Adoptive Cell Therapy (ACT) with Autologous Tumor-Infiltrating Lymphocytes (HS-IT101) Following Lymphodepleting Conditioning with Fludarabine and Cyclophosphamide, Followed by IL-2 in Patients with Advanced NSCLC.

Conditions

• Advanced Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Cyclophosphamide	Cyclophosphamide administered via intravenous infusion once daily for 3 consecutive days.
DRUG	Fludarabine	Fludarabine is administered once daily via intravenous infusion for 4 consecutive days.
DRUG	IL-2 (interleukin 2)	IL-2 administered subcutaneously once daily. Dosing may be adjusted based on subject tolerance, including modifications to dose quantity, administration frequency, or complete treatment discontinuation, with a maximum treatment duration of 3 days.
DRUG	HS-IT101 monotherapy	TIL Injection administered by intravenous infusion over 30-60 minutes.

Timeline

• Start date: 2025-08-30
• Primary completion: 2026-08-30
• Completion: 2027-08-30
• First posted: 2025-08-05
• Last updated: 2025-08-19

Locations

1 site across 1 country: China