Actively Recruiting
Autologous Tumor-Infiltrating Lymphocyte (GT307 Injection ) for Treatment of Patients With Solid Tumours
Led by Grit Biotechnology · Updated on 2026-01-26
18
Participants Needed
3
Research Sites
156 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 study is a single arm, open design aimed at evaluating the safety and tolerability of Autologous Tumor-Infiltrating Lymphocyte (GT307 injection ) for treatment of patients with solid tumours,while evaluating pharmacokinetic characteristics and efficacy assessment to determine the optimal biological dose (OBD).
CONDITIONS
Official Title
Autologous Tumor-Infiltrating Lymphocyte (GT307 Injection ) for Treatment of Patients With Solid Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily participate in the study and sign the informed consent form
- Aged 18 to 70 years old (eligibility for those over 70 determined by investigator and medical monitor)
- Diagnosed with advanced solid tumors with failed or unavailable standard treatment
- Have at least one lesion untreated by radiotherapy or local therapies with accessible tumor tissue for TIL preparation
- Have at least one measurable lesion after tumor sampling that meets RECIST v1.1 criteria and is untreated or progressed after prior therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival time of at least 12 weeks
- Adequate major organ function based on blood counts, liver, kidney, coagulation, cardiac, and pulmonary parameters
- Non-surgically sterilized women of childbearing potential must use approved contraception during treatment and for 1 year after, with a negative pregnancy test before cell infusion
- Prior treatment adverse reactions resolved to CTCAE 5.0 Grade 1 or lower or deemed non-interfering by investigator
- Imaging confirmation of disease progression after last prior treatment for subjects enrolled due to progression
You will not qualify if you...
- Spinal cord compression not relieved by surgery or radiotherapy (unless symptoms relieved for at least 1 week prior to sampling)
- Uncontrolled tumor-related pain or unstable analgesic treatment
- History of bleeding events within 3 months or high risk of major bleeding
- History of arterial or venous thrombotic events within 3 months
- Interstitial pneumonia or active respiratory diseases severely impairing lung function
- Significant cardiovascular diseases including congestive heart failure (NYHA > Class 2), unstable angina, recent myocardial infarction, or arrhythmias needing treatment
- More than 3 untreated central nervous system metastases, or CNS metastases larger than 1 cm or progressing
- History or active autoimmune diseases requiring systemic corticosteroids or immunosuppressants
- Refractory epilepsy, uncontrolled pleural or pericardial effusion, active gastrointestinal bleeding, or contraindications to IL-2
- History of other malignant tumors within 5 years except certain treated skin or breast cancers
- History of infectious diseases such as HIV, active hepatitis, tuberculosis, EBV, or CMV infections within 1 year
- Prior allogeneic bone marrow or solid organ transplantation
- Use of anti-angiogenic agents within 4 weeks prior to sampling
- Recent systemic anti-tumor therapy within 4 weeks unless meeting specific exceptions
- Prior genetically modified or edited cell therapy within 1 year
- History of hypersensitivity to study drug components
- Known mental illness, substance abuse, or addiction
- Grade 3 or higher adverse reactions from prior immunotherapy not resolved to Grade 1 within 28 days
- Pregnancy, lactation, or planning pregnancy within 1 year after treatment
- Participation in other investigational drug studies within 4 weeks
- Other conditions deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Beijing Arion Cancer Center
Beijing, Beijing Municipality, China
Actively Recruiting
2
Beijing GoBroad hospital
Beijing, Beijing Municipality, China
Actively Recruiting
3
The Affiliated Hospital Of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221000
Actively Recruiting
Research Team
Z
Zhengxiang Han, MD
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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