Actively Recruiting
Study of GC101 TIL in Brain Glioma (Soochow2)
Led by Shanghai Juncell Therapeutics · Updated on 2025-12-11
50
Participants Needed
1
Research Sites
316 weeks
Total Duration
On this page
Sponsors
S
Shanghai Juncell Therapeutics
Lead Sponsor
S
Second Affiliated Hospital of Soochow University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with malignant glioma . Autologous TILs are expanded from tumor resections and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.
CONDITIONS
Official Title
Study of GC101 TIL in Brain Glioma (Soochow2)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- Diagnosed with primary, relapsed, or metastasized brain glioma
- Expected life expectancy longer than 3 months
- Karnofsky score 60% or higher, or ECOG score between 0 and 2
- Failed standard treatments or no standard treatments available
- Tumor suitable for biopsy or resection, or malignant fluid for TIL isolation
- At least one tumor lesion that can be evaluated
- Adequate blood counts and organ function within 7 days before enrollment
- No contraindications for operation or biopsy
- Women with child-bearing potential agree to use effective contraception during and 1 year after lymphodepletion
- No tumor-targeting therapies within 28 days before TIL collection
- Able to understand and sign informed consent
- Able to comply with follow-up and study requirements
You will not qualify if you...
- Need glucocorticoid treatment over 15 mg prednisone daily or immune-modulating treatment for autoimmune diseases
- Forced expiratory volume in 1 second less than 2 liters or lung diffusion capacity under 40%
- Severe heart problems including advanced heart failure, low blood pressure, uncontrolled coronary disease, or heart rhythm disorders
- HIV infection, active hepatitis B or C, syphilis, or positive related antibodies
- Severe physical or mental illness
- Active systemic infection or positive blood cultures
- Treatment with other medicines, biologics, chemo- or radiotherapy within the last month
- Allergy to substances similar to cell therapy
- Prior immunotherapy with severe immune-related adverse events (level above 3)
- Prior anti-tumor treatment side effects not resolved to mild levels
- Pregnancy or breastfeeding
- History of organ or stem cell transplantation or renal replacement therapy
- Other severe systemic diseases or conditions unsuitable for the study by investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Actively Recruiting
Research Team
G
GC Clinical
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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