Actively Recruiting
A Phase I Trial of Tumor-Associated Lymph Node T-Cell Injection With Advanced Malignant Solid Tumors
Led by Guangzhou FineImmune Biotechnology Co., LTD. · Updated on 2025-03-26
32
Participants Needed
1
Research Sites
148 weeks
Total Duration
On this page
Sponsors
G
Guangzhou FineImmune Biotechnology Co., LTD.
Lead Sponsor
S
Sun Yat-sen University
Collaborating Sponsor
AI-Summary
What this Trial Is About
A Phase I clinical trial of the safety and tolerability of tumor-associated lymph node T cell injection in patients with advanced malignant solid tumors, including but not limited to melanoma, head and neck tumors, cervical cancer, and non-small cell lung cancer.
CONDITIONS
Official Title
A Phase I Trial of Tumor-Associated Lymph Node T-Cell Injection With Advanced Malignant Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent and able to comply with study visits and procedures
- Age between 18 and 75 years, male or female
- ECOG performance status score of 0 or 1
- Expected survival of at least 12 weeks
- Confirmed advanced malignant solid tumors that have failed standard treatment or lack effective options, including melanoma, head and neck tumors, cervical cancer, and non-small cell lung cancer
- Presence of tumor-associated lymph nodes suitable for resection with T cells isolation (tissue of at least 1 cm3, untreated or progressed after local treatment)
- At least one evaluable lesion after sampling, measurable by CT or MRI according to RECIST v1.1 criteria
- Sufficient organ and bone marrow function without recent blood transfusions or hematopoietic stimulating factors within 14 days prior to screening
- Fertile men and women of reproductive age agree to use effective contraception from consent signing until one year after cell transfusion, and women have a negative pregnancy test at screening
You will not qualify if you...
- Presence of meningeal or active brain metastases
- Prior allogeneic bone marrow or organ transplantation, or awaiting transplantation
- Positive tests for hepatitis B, hepatitis C, HIV, syphilis, cytomegalovirus IgM, Epstein-Barr virus IgM, or human T-lymphotropic virus antibodies
- Recent chemotherapy, targeted therapy, biologic therapy, or extensive radiotherapy within specified timeframes before pretreatment
- Ongoing adverse events from previous antitumor therapy not resolved to grade 1 or baseline except specified exceptions
- Immunization with live attenuated vaccines within 28 days prior or planned during the study
- Major surgery within 28 days prior to pretreatment or planned during the study
- Long-term systemic corticosteroids or immunosuppressive treatment except local use around sampling or during the study
- Active systemic infections requiring intravenous antibiotics within 7 days prior to screening
- Active or past autoimmune diseases likely to recur, with some exceptions
- History of interstitial lung disease, severe lung impairment, or radiation pneumonia
- Severe liver conditions including hepatic encephalopathy, hepatorenal syndrome, or advanced cirrhosis
- Uncontrolled third space effusions such as pleural fluid or ascites
- History of severe cardiovascular or cerebrovascular disease
- Pulmonary embolism or severe deep vein thrombosis requiring certain treatments
- Severe immune-related adverse events from prior immunotherapy
- Contraindications for immune checkpoint treatments
- Participation in other interventional clinical trials
- Pregnant or lactating women
- Other conditions affecting compliance or suitability for the study as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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