MedTrace Logo

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

NCT07770802 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-08-18

No results posted yet for this study

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.

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 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.

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
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2026-10-31
Completion
2027-08-31

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 NCT07770802 on ClinicalTrials.gov