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RECRUITING
NCT07830342
PHASE1

A Clinical Study of HS-IT101 Injection in Patients With Advanced Non-Small Cell Lung Cancer(FASTIL-Lung02)

Sponsor: Hangzhou Huasai Biomedicine Co., Ltd.

View on ClinicalTrials.gov

Summary

A Single-Arm, Open-Label, Interventional Study to Evaluate the Efficacy of HS-IT101 Autologous Tumor-Infiltrating Lymphocyte (TIL) Cell Therapy After Lymphodepleting Preconditioning with Fludarabine and Cyclophosphamide and Subsequent Interleukin-2 Therapy in Patients with Advanced Non-Small Cell Lung Cancer.

Official title: A Phase Ib Clinical Study to Evaluate the Safety and Efficacy of HS-IT101 Injection in Patients With Advanced Non-Small Cell Lung Cancer.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2026-09-21

Completion Date

2028-10

Last Updated

2026-10-14

Healthy Volunteers

No

Conditions

Interventions

DRUG

Cyclophosphamid

Cyclophosphamide administered via intravenous infusion once daily for 3 consecutive days.

DRUG

Fludarabine

Fludarabine is administered once daily via intravenous infusion for 3 consecutive days.

DRUG

Interleukin 2 subcutaneous injection

IL-2 is administered subcutaneously or intravenously once daily. The dose may be adjusted based on the subject's tolerance, including modifications to the dose, dosing frequency, or complete discontinuation of treatment, Up to three administrations.

Locations (1)

Shanghai Pulmonary Hospital

Shanghai, China