Actively Recruiting
Study of Autologous Tumor-Draining Lymph Node-Derived Lymphocytes for Advanced HER2-Negative Breast Cancer
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2023-08-08
170
Participants Needed
1
Research Sites
612 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
RATIONALE: Patients with HER2-negative advanced breast cancer have limited choice on targeted therapies, and often show only modest responses to available immunotherapies. Adoptive cell therapy with tumor-infiltrating lymphocytes has difficulties in preparing enough cells from solid tumors and overcoming the exhaustion and dysfunction of T cells, which limit its clinical use. Tumor-draining lymph node-derived lymphocytes (LNLs) that have abundant tumor-specific T cells, rather than exhausted T cells, are easier to produce. It is not yet known whether LNL treatment is safe and effective in patients with advanced HER2-negative breast cancer. PURPOSE: This open-label phase I/II trial is to study the safety and efficacy of autologous LNL in patients with advanced HER2-negative breast cancer.
CONDITIONS
Official Title
Study of Autologous Tumor-Draining Lymph Node-Derived Lymphocytes for Advanced HER2-Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent for study participation
- Female aged between 18 and 70 years
- Locally advanced or recurrent inoperable HER2-negative breast cancer (Stage IIIB-IIIC) or metastatic breast cancer (Stage IV)
- For ER-positive and/or PR-positive breast cancer, failed at least one hormonal therapy or CDK4/6 inhibitor or suitable for chemotherapy; prior chemotherapy may be unlimited
- Prior treatments for Stage IIIB, IIIC or IV breast cancer have not included the chemotherapeutic drugs or immune checkpoint inhibitors used in this study, or if used in (neo)adjuvant setting, at least 12 months have passed since completion
- No prior adoptive cell therapy
- Suitable for treatment with nab-paclitaxel or gemcitabine/carboplatin and camrelizumab
- Accessible tumor-draining lymph nodes for surgery to grow LNL
- Measurable disease based on RECIST 1.1 criteria
- Recent or new biopsy available for molecular subtype and PD-L1 expression unless contraindicated
- ECOG performance status of 0 or 1
- Life expectancy of at least 4 months
- Adequate organ function including blood counts, liver, kidney, coagulation, heart (LVEF ≥50%), and lung (FEV1 ≥60%)
- Female participants of childbearing potential must use contraception during and one year after treatment and have a negative pregnancy test within 7 days prior to LNL infusion
- Required washout periods from prior therapies met: angiogenesis inhibitors (4 weeks), chemotherapy/targeted therapy (3 weeks), radiotherapy (2 weeks), hormonal therapy (1 week)
- Recovery from prior therapy-related adverse events to Grade ≤1 or stable organ function except for certain irreversible conditions not worsened by LNL infusion
You will not qualify if you...
- Rapidly progressing tumors
- Active CNS metastases or carcinomatous meningitis except for stable, treated brain metastases meeting imaging criteria
- Spinal cord compression not relieved by surgery or radiotherapy
- Uncontrolled pleural effusion, pericardial effusion, or ascites (indwelling catheters allowed)
- Uncontrolled cancer pain without a treatment plan
- Additional malignancy within last 5 years except certain skin or in situ cancers
- History of significant cardiovascular disease including congestive heart failure (NYHA Class >2), recent myocardial infarction, or serious arrhythmias
- Interstitial or active pneumonia affecting lung function
- Active infection requiring treatment or unexplained fever >38.5°C unrelated to cancer
- Recent arterial or venous thrombotic events within 5 months
- Participation in another clinical study with investigational agents or devices within 4 weeks
- Known psychiatric, alcohol, or substance abuse disorders
- Pregnancy or breastfeeding
- Active or history of autoimmune disease requiring systemic treatment
- History of immunodeficiency or positive HIV serology
- Recent or untreated tuberculosis
- Active hepatitis B or C unless controlled with normal viral levels and treatment
- Receipt of live vaccine within 4 weeks prior or planned during study
- History of allogeneic bone marrow or organ transplant
- Known allergy or hypersensitivity to study drugs or components
- Contraindications to IL-2 including refractory epilepsy or active gastrointestinal bleeding
- History of Grade ≥2 neuropathy
- Use of prohibited medications within 7 days prior to enrollment
- Any condition that may interfere with study participation or safety as judged by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510120
Actively Recruiting
Research Team
S
Shicheng Su, M.D., Ph.D.
CONTACT
E
Erwei Song, M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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