Actively Recruiting

Phase 1
Age: 18Years - 70Years
All Genders
NCT06088472

TIL Injection for the Treatment of Metastatic or Recurrent Solid Tumors

Led by Grit Biotechnology · Updated on 2025-09-29

12

Participants Needed

1

Research Sites

349 weeks

Total Duration

On this page

Sponsors

G

Grit Biotechnology

Lead Sponsor

T

The Affiliated Hospital of Xuzhou Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

This is a single-center, single-arm phase I clinical trial.The study process was divided into: screening period, sampling and production period, NMA-LD chemotherapy , treatment and observation period, and follow-up period.

CONDITIONS

Official Title

TIL Injection for the Treatment of Metastatic or Recurrent Solid Tumors

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntarily participate in the study, sign informed consent, and follow the study protocol
  • Confirmed diagnosis of unresectable recurrent or metastatic solid tumor by histology or cytology
  • At least one resectable lesion (preferably superficial metastatic lymph nodes) untreated by radiation or local therapies
  • Tissue blocks with a volume of at least 0.5 cubic centimeters available for TIL preparation
  • Minimally invasive treatment for tissue sampling where possible
Not Eligible

You will not qualify if you...

  • Symptomatic or untreated central nervous system metastases, except stable brain metastases without medication for 3 months and no hormone dependence
  • Active autoimmune disease, history of autoimmune disease, or need for systemic steroids or immunosuppressants within 14 days before chemotherapy
  • Arterial or venous thrombotic events within 6 months before enrollment, including stroke, deep vein thrombosis, or pulmonary embolism
  • Active infections requiring systemic treatment or unexplained fever above 38.5°C during screening (except tumor fever)
  • Refractory epilepsy, ascites, active gastrointestinal bleeding, or contraindications to IL-2
  • Prior allogeneic bone marrow or organ transplantation
  • History of hypersensitivity to components of study drugs including TIL, cyclophosphamide, fludarabine, IL-2, DMSO, human serum albumin, dextran-40, or certain antibiotics

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China, 221000

Actively Recruiting

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Research Team

Z

Zhengxiang Han, PHD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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