Actively Recruiting
Phase I Clinical Study of Tumor-associated Lymph Node T Cell Therapy for Advanced Solid Tumors
Led by Guangzhou FineImmune Biotechnology Co., LTD. · Updated on 2024-12-03
23
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A total of 17 to 23 participants are anticipated to be enrolled in the Phase I clinical trial, which is further divided into two distinct parts: one part involves single-agent cell therapy, while the other entails a combination of cell therapy and Serplulimab Injection. To be more precise, the study aims to include patients who have been diagnosed with metastatic or locally advanced refractory/recurrent malignant solid tumors and have shown resistance to standard therapeutic interventions. These tumor types may encompass head and neck cancer, ovarian cancer, lung cancer, melanoma, and others.
CONDITIONS
Official Title
Phase I Clinical Study of Tumor-associated Lymph Node T Cell Therapy for Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be between 18 and 75 years old
- Have metastatic or locally advanced refractory/recurrent malignant solid tumors that failed standard therapy or could not tolerate standard treatment
- Have at least one measurable target lesion
- Voluntarily agree to participate and sign informed consent
- Have at least one resectable tumor-associated lymph node suitable for T cell isolation
- Have an ECOG performance status of 0 or 1
- Have an expected survival time longer than 6 months
- Female participants with fertility potential must have a negative pregnancy test
- All participants with fertility potential must agree to use effective contraception during the study and for 12 months after the last dose
- Be willing to regularly visit the hospital for treatment, testing, evaluation, and management throughout the study period
You will not qualify if you...
- Have moderate to severe infection or be at risk of opportunistic infections
- Have active autoimmune diseases except vitiligo or healed childhood asthma/allergies
- Have uncontrolled diseases such as symptomatic congestive heart failure, unstable angina, arrhythmias (except stable atrial fibrillation), or significant carotid stenosis
- Have acute systemic infections, coagulation disorders, or serious cardiopulmonary diseases
- Have used large amounts of glucocorticoids or immunosuppressants within 4 weeks
- Have a history of severe allergic reactions to study drugs
- Have uncontrolled central nervous system metastases or cancerous meningitis
- Are pregnant, breastfeeding, or unable to use contraception
- Have had recent anti-tumor therapy within specified washout periods
- Are enrolled in another interventional clinical study concurrently
- Have a history of allogeneic organ or hematopoietic stem cell transplantation
- Have interstitial lung disease, suspected interstitial pneumonia, or severe lung diseases affecting lung function
- Have primary immunodeficiency, positive HIV test, chronic hepatitis B or C infection
- Have certain cardiovascular diseases including recent myocardial ischemia or infarction, symptomatic pulmonary embolism, severe heart failure, ventricular arrhythmias, or stroke within 6 months
- Have pleural, pericardial effusion, or ascites not controllable by drainage
- Have received live vaccines within 30 days before study or plan to receive during study
- Have diseases causing severe hypersensitivity to monoclonal antibodies
- Have other conditions that pose risk or interfere with study evaluation
- Have a second primary tumor within 5 years
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Gaungdong, China, 510700
Actively Recruiting
Research Team
Y
Ying Cheng, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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