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HS-IT101 Injection for Advanced NSCLC

NCT07105176 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-08-19

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Qingdao Sino-Cell Biomedicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-30
Primary Completion
2026-08-30
Completion
2027-08-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07105176 on ClinicalTrials.gov