Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221000
Actively Recruiting
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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