Actively Recruiting
A Study of GC101 TIL in Advanced Breast Cancer (10hospital)
Led by Shanghai Juncell Therapeutics · Updated on 2025-12-11
50
Participants Needed
1
Research Sites
317 weeks
Total Duration
On this page
Sponsors
S
Shanghai Juncell Therapeutics
Lead Sponsor
S
Shanghai 10th People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy (GC 101 TIL) in patients with advanced breast cancer. Autologous TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.
CONDITIONS
Official Title
A Study of GC101 TIL in Advanced Breast Cancer (10hospital)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Histologically diagnosed primary, relapsed, or metastatic breast cancer
- Expected life span longer than 3 months
- Karnofsky score 60% or higher or ECOG performance status 0-2
- Have failed standard treatments or have no standard treatments available
- Tumor regions available for biopsy or resection, or malignant body fluid for TIL isolation
- At least one tumor lesion that can be evaluated
- Hematology and chemistry lab values within 7 days before enrollment meeting specified thresholds
- No absolute or relative contraindications to surgery or biopsy
- Women with childbearing potential agree to use effective contraception during and for one year after lymphodepletion
- Ceased all tumor-targeting therapies (radiotherapy, chemotherapy, biologics) at least 28 days before TIL collection
- Ability to understand and sign informed consent
- Willingness to adhere to follow-up visit schedule and study requirements
You will not qualify if you...
- Need for glucocorticoid treatment with prednisone over 15 mg daily or autoimmune diseases requiring immunomodulatory therapy
- Forced expiratory volume in one second (FEV1) less than 2 liters or lung diffusion capacity (DLCO) below 40%
- Significant heart problems including NYHA Class III/IV heart failure, unstable low blood pressure, severe coronary artery disease, ejection fraction under 35%, or severe arrhythmias
- HIV infection, active hepatitis B or C, syphilis infection
- Severe physical or mental illness
- Active systemic infection requiring treatment or positive blood cultures
- Receiving other medicines, biologic therapy, chemotherapy, or radiotherapy within one month or currently
- History of allergy to substances similar to cell therapy
- Previous immunotherapy adverse events above grade 3
- Previous anti-tumor treatment side effects not resolved to grade 1 or below (excluding non-safety concerns like hair loss)
- Pregnant or breastfeeding women
- History of organ or stem cell transplantation, or renal replacement therapy
- Other severe systemic diseases or conditions making participation inappropriate as judged by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Tenth People's Hospital
Shanghai, 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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