Actively Recruiting
GT101 Injection for the Treatment of Metastatic or Recurrent Solid Tumors
Led by Grit Biotechnology · Updated on 2026-04-14
31
Participants Needed
5
Research Sites
214 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, single-arm phase I clinical trial.The study process was divided into: screening period, sampling and production period, lymphodepleting chemotherapy period, treatment and observation period, and follow-up period. The study is designed to enroll 20-31 subjects, with 14-20 subjects expected to be evaluable, in an "autologous tumor-infiltrating lymphocyte therapy" regimen that includes： 1. Clear lymphatic pretreatment (FC regimen: cyclophosphamide + fludarabine). 2. GT101 infusion. 3. post-infusion treatment (interleukin-2 intravenous push).
CONDITIONS
Official Title
GT101 Injection for the Treatment of Metastatic or Recurrent Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be able to understand the study requirements and provide written informed consent
- Confirmed diagnosis of unresectable recurrent or metastatic solid tumor
- At least one resectable lesion (preferably superficial metastatic lymph nodes) not treated with radiation or other local therapies
- Tissue mass of at least 1.0g available for autologous tumor-infiltrating lymphocyte preparation
- Minimally invasive treatment where possible
You will not qualify if you...
- Symptomatic and/or untreated central nervous system metastases (except stable brain metastases without medication for 3 months)
- Active autoimmune disease, history of autoimmune disease, or need for systemic steroids or immunosuppressive therapy
- Arterial or venous thrombotic events within 6 months prior to surgery
- Active infections requiring systemic anti-infective treatment or unexplained fever over 38.56C during screening (except tumor fever)
- Refractory epilepsy, poorly controlled pleural or abdominal fluid, active gastrointestinal bleeding, or contraindications to IL-2
- Participation in other clinical trials within 28 days before the first dose or planned concurrent participation
- Previous allogeneic bone marrow transplantation or organ allograft
- History of hypersensitivity to study drugs or their components, including autologous lymphocytes, cyclophosphamide, fludarabine, IL-2, DMSO, human serum albumin, dextran-40, and specified antibiotics
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
The fifth medical center of the General Hospital of the Chinese people's Liberation Army
Beijing, Beijing Municipality, China, 100039
Actively Recruiting
2
Chongqing University Cancer Center
Chongqing, Chongqing Municipality, China, 400030
Actively Recruiting
3
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 201321
Not Yet Recruiting
4
West China School of Medicine/West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610064
Actively Recruiting
5
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
Research Team
H
Haifeng Qin, PhD
CONTACT
Y
Yongsheng Wang, 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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