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NOT YET RECRUITING
NCT07770802
PHASE1

Clinical Study of HS-IT101 Injection in the Treatment of Advanced Renal Cancer

Sponsor: Qingdao Sino-Cell 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 Renal Cancer.

Official title: A Phase Ib, Open-Label Clinical Study of HS-IT101 Injection in Patients With Advanced Renal Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2026-10

Completion Date

2027-08

Last Updated

2026-08-18

Healthy Volunteers

No

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 4 consecutive days.

DRUG

Interleukin 2 subcutaneous injection

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.