Actively Recruiting
A Clinical Study to Evaluate the Safety and Efficacy of Autologous Tumor Infiltrating Lymphocytes Injection in Patients With Advanced Breast Cancer
Led by Shanghai Juncell Therapeutics · Updated on 2025-12-11
50
Participants Needed
1
Research Sites
52 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
Researchers are evaluating the safety and effectiveness of tumor infiltrating lymphocyte (TIL) therapy using GC101 TIL in patients with advanced breast cancer. This early phase 1 clinical study focuses on patients who have either primary, relapsed, or metastatic breast cancer and have failed standard treatments or have no available standard options. The study aims to understand how this therapy works in controlling disease and its side effects. The treatment involves collecting a patient's own TILs from tumor biopsies or resections, expanding them in the lab, and then infusing between 1 billion to 50 billion cells intravenously. Before the TIL infusion, patients receive a non-myeloablative lymphodepletion regimen that includes a single dose of hydroxychloroquine (600 mg) and cyclophosphamide. The infusion itself takes about 30 to 120 minutes. Participants will be monitored for adverse events over six months and followed up to 36 months to assess tumor response, disease control, duration of response, progression-free survival, and overall survival. Quality of life changes will also be tracked. Throughout the study, patients undergo blood tests, tumor evaluations, and regular follow-up visits to measure safety and treatment effects. The total study duration may extend up to three years for outcome assessments.
CONDITIONS
Brief Title
A Study of GC101 TIL in Advanced Breast Cancer (10hospital)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- Histologically diagnosed with primary, relapsed, or metastatic breast cancer
- Expected life span more than 3 months
- Karnofsky score 60% or higher or ECOG score between 0 and 2
- Failed standard treatment regimens or no standard treatments available
- Tumor regions suitable for biopsy or resection, or malignant fluid where TILs can be isolated
- At least one evaluable tumor lesion
- Adequate blood counts and organ function within 7 days prior to enrollment
- No contraindications to operation or biopsy
- Willing to use effective contraception if of child-bearing potential
- All tumor-targeting therapies stopped at least 28 days before TIL collection
- Able to understand and sign informed consent
- Able to follow follow-up visit plans and study requirements
You will not qualify if you...
- Need for glucocorticoid treatment over 15mg prednisone daily or immunomodulatory treatment for autoimmune diseases
- Lung function with forced expiratory volume in 1 second less than 2L or DLCO less than 40%
- Significant heart problems including severe heart failure, low blood pressure, uncontrolled coronary disease, or low ejection fraction
- Active infections including HIV, hepatitis B or C, or syphilis
- Severe physical or mental illness
- Active systemic infection or positive blood cultures
- Recent or ongoing treatment with other medicines, biologics, chemotherapy, or radiotherapy within a month
- History of allergy to substances similar to cell therapy
- Previous immunotherapy-related adverse events greater than level 3
- Unresolved anti-tumor treatment adverse events above grade 1 (except alopecia)
- Pregnant or breastfeeding women
- History of organ or stem cell transplantation or renal replacement therapy
- Other severe systemic diseases or conditions deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single infusion with lymphodepletion treatment prior to infusion
Participants receive an intravenous infusion of autologous Tumor Infiltrating Lymphocytes (TIL) after lymphodepletion treatment with hydroxychloroquine and cyclophosphamide.
1 treatment visit (in-person)
Duration - Up to 36 months
Participants are monitored for safety, response, and quality of life after treatment.
Regular visits for assessments up to 36 months
Trial Site Locations
Total: 1 location
1
Shanghai Tenth People's Hospital
Shanghai, China
Actively Recruiting
Research Team
G
GC Clinical
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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