Actively Recruiting
TIL Gean Therapy Combined With Immunotherapy for Advanced or Metastatic Refractory Breast Cancer
Led by Essen Biotech · Updated on 2024-11-12
85
Participants Needed
1
Research Sites
122 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This Phase I/II study evaluates the safety and efficacy of autologous tumor-infiltrating lymphocytes (TIL) therapy combined with Pembrolizumab (Keytruda) immunotherapy in patients with advanced or metastatic refractory breast cancer. TILs will be harvested from patients' tumors, expanded in vitro, and infused back into the patients following a non-myeloablative lymphodepletion regimen. Pembrolizumab, a monoclonal antibody that targets the PD-1 receptor on T cells, will be administered to enhance the immune response. The primary endpoint is to determine the objective response rate (ORR) of this combined therapy. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), and quality of life (QoL). This trial aims to provide a novel, personalized treatment option for patients with limited therapeutic alternatives.
CONDITIONS
Official Title
TIL Gean Therapy Combined With Immunotherapy for Advanced or Metastatic Refractory Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 16 and 90 years
- Histologically confirmed primary, relapsed, or metastatic breast cancer
- Expected life span longer than 3 months
- Karnofsky score 60% or higher, or ECOG performance status 0 to 2
- Have failed standard treatment or no standard treatment options available
- Tumor areas suitable for biopsy or resection, or malignant body fluid available for TIL isolation
- At least one measurable tumor lesion
- Blood counts within specified limits (WBC 2.5 x 10^9/L, neutrophils 1.5 x 10^9/L, lymphocytes 0.7 x 10^9/L, platelets 100 x 10^9/L, hemoglobin 90 g/L)
- Coagulation tests within acceptable ranges unless on recent anticoagulants
- Kidney and liver function tests within specified limits
- No contraindications to surgery or biopsy
- Women of childbearing potential must use effective contraception during and for 1 year after lymphodepletion
- Ceased all tumor-targeting therapies at least 28 days before TIL collection
- Able to understand and sign informed consent
- Willing to comply with follow-up visits and study requirements
You will not qualify if you...
- Need for glucocorticoid treatment with prednisone over 15 mg daily or immunomodulatory treatment for autoimmune diseases
- Lung function with forced expiratory volume in 1 second less than 2 liters or carbon monoxide diffusion capacity below 40%
- Significant heart problems including NYHA Grade III/IV heart failure, uncontrolled low blood pressure, severe coronary disease, ejection fraction below 35%, or serious heart rhythm disorders
- Infection with HIV, active hepatitis B or C, syphilis, or positive for related antibodies
- Severe physical or mental illnesses
- Active systemic infections requiring treatment
- Use of other medicines, biological therapies, chemotherapy, or radiotherapy within the past month
- History of allergy to compounds similar to cell therapy
- Previous immunotherapy adverse events worse than grade 3
- Ongoing adverse effects from prior anti-tumor treatments not resolved to mild levels
- Pregnancy or breastfeeding
- History of organ transplantation, stem cell transplantation, or kidney replacement therapy
- Other severe systemic diseases or conditions considered unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
District One Hospital
Beijing, Beijing Municipality, China, 086-373
Actively Recruiting
Research Team
R
Rhoda M Smith, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here