Actively Recruiting
Phase I 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 2023-11-08
24
Participants Needed
1
Research Sites
426 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 phase I trial is mainly to study the safety of autologous LNL in patients with advanced HER2-negative breast cancer.
CONDITIONS
Official Title
Phase I 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 to participate
- Female aged between 18 and 70 years
- Diagnosis of locally advanced or recurrent inoperable HER2-negative breast cancer (Stage IIIB to IIIC) not treatable with curative intent or metastatic breast cancer (Stage IV)
- For ER-positive and/or PR-positive breast cancer, failure of at least one line of hormonal therapy or CDK4/6 inhibitor or suitable for chemotherapy; unlimited prior chemotherapy allowed for ER/PR-positive and triple-negative breast cancer
- No prior adoptive cell therapy
- Suitable for treatment with camrelizumab and another anti-tumor drug (chemotherapy, ADC, or PARP inhibitor) per investigator
- Accessible tumor-draining lymph nodes for surgery to grow LNL
- Measurable disease based on RECIST 1.1 criteria
- Recent or new biopsy from tumor lesion for molecular subtype and PD-L1 expression unless contraindicated
- ECOG performance status of 0 or 1
- Life expectancy of 4 months or more
- Adequate normal organ function including specified blood counts, liver, renal, coagulation, cardiac, and pulmonary function
- Female participants of childbearing potential willing to use contraception during study and one year after last dose and negative pregnancy test prior to LNL infusion
- Specified washout periods from prior therapies and recovery from therapy-related adverse events to Grade 1 or less except certain exceptions
You will not qualify if you...
- Rapidly progressing tumors
- Active CNS metastases or carcinomatous meningitis except stable treated CNS metastases without medication or corticosteroid dependence
- Unrelieved spinal cord compression
- Uncontrolled pleural, pericardial effusion or ascites unless indwelling catheter present
- Uncontrolled cancer pain without treatment plan
- Known additional progressing malignancy requiring treatment within last 5 years except certain skin and thyroid cancers
- History of significant cardiovascular disease including heart failure, unstable angina, recent myocardial infarction, or arrhythmias requiring treatment
- Interstitial or active pneumonia affecting pulmonary function
- Active infection requiring systemic therapy or unexplained fever above 38.5 0C not caused by cancer
- Recent arterial or venous thrombotic events
- Participation in another clinical study with investigational agents within 4 weeks
- Psychiatric, alcohol, or substance abuse disorders
- Pregnancy or breastfeeding
- Active or history of autoimmune disease requiring systemic treatment
- History of immunodeficiency or positive HIV test
- Tuberculosis within past year or untreated active tuberculosis
- Active hepatitis B or C unless viral levels normal and under treatment
- Recent or planned live vaccination
- History of bone marrow or organ transplant
- Allergy or hypersensitivity to study drugs or components
- Contraindications to IL-2 use including epilepsy or active gastrointestinal bleeding
- History of Grade 2 or higher neuropathy
- Use of prohibited medications or conditions interfering with study participation or safety as judged by investigator
AI-Screening
AI-Powered 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
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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