Actively Recruiting
A Phase I Clinical Trial of the Safety and Tolerability of Tumor-Associated Lymph Node T-Cell Injection (TAL-T) in Subjects With Advanced Malignant Solid Tumors
Led by Guangzhou FineImmune Biotechnology Co., LTD. · Updated on 2025-03-26
32
Participants Needed
1
Research Sites
52 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
Researchers are evaluating the safety and tolerability of tumor-associated lymph node T cell (TAL-T) therapy in patients with advanced malignant solid tumors, including melanoma, head and neck tumors, cervical cancer, and non-small cell lung cancer. This Phase I trial aims to explore dosage ranges and assess initial safety and possible effectiveness in patients who have failed standard treatments or have no effective options. Treatment involves removing at least one lymph node sample from each participant to isolate and expand TAL-T cells outside the body. Patients undergo lymphodepletion before receiving TAL-T cell infusions. Additionally, Serplulimab injections are given intravenously before and after TAL-T cell infusion. The study has two phases: an exploration dose range phase with increasing doses to evaluate safety, followed by an expansion phase focusing on three preferred tumor types, with participant numbers adjusted based on earlier results. Participants will be monitored from the time they consent until 54 weeks after cell reinfusion for any adverse events or serious adverse events. Assessments include imaging to evaluate lesions, organ and bone marrow function tests, and questionnaires related to safety and treatment response. The trial measures outcomes such as objective response rate, disease control rate, duration of response, progression-free survival, and overall survival over two years, with safety data carefully collected throughout the study period.
CONDITIONS
Brief 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 18 to 75 years, male or female
- ECOG performance status of 0 or 1
- Expected survival of at least 12 weeks
- Advanced malignant solid tumors confirmed by cytology or histopathology, including melanoma, head and neck tumors, cervical cancer, and non-small cell lung cancer, having failed standard treatment or lacking effective options
- Presence of tumor-associated lymph nodes suitable for resection and T cell isolation (tissue size ≥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
- Sufficient organ and bone marrow function without recent blood transfusions or stimulating factors
- Fertile participants agree to use effective contraception from consent until one year after cell transfusion, with women having a negative pregnancy test at screening
You will not qualify if you...
- Meningeal metastases or active brain metastases
- Previous allogeneic bone marrow or organ transplantation
- Positive for hepatitis B, hepatitis C, HIV, syphilis, CMV IgM, EBV IgM, or HTLV antibodies
- Recent chemotherapy, targeted therapy, biologic therapy, radical or extensive radiotherapy, or certain traditional medicines within defined timeframes before treatment
- Unresolved adverse events from prior therapies except specific controlled conditions
- Recent live attenuated vaccine or planned vaccination during the study
- Major surgery within 28 days prior or planned during the study
- Long-term systemic corticosteroids or immunosuppressive agents use excluding local or inhaled forms
- Active systemic infections needing IV antibiotics within 7 days prior to screening
- Active or past autoimmune diseases likely to recur, except controlled hypothyroidism or type 1 diabetes
- Interstitial lung disease, severe lung impairment, hepatic encephalopathy, severe liver cirrhosis or failure
- Uncontrolled third space effusions like pleural fluid or ascites
- History of severe cardiovascular or cerebrovascular disease
- Pulmonary embolism or severe deep vein thrombosis requiring interventions or therapeutic anticoagulation
- Grade 3 or higher immune-related adverse events from prior immunotherapy
- Contraindications to immune checkpoint treatments
- Participation in other interventional clinical trials
- Pregnant or lactating women
- Any condition affecting compliance or suitability for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration varies across dose exploration and expansion phases as per protocol
Participants undergo lymph node resection to collect tumor-associated lymph node T cells, followed by lymphodepletion and infusion of TAL-T cells. Serplulimab injections are given intravenously before and after TAL-T infusion.
Multiple visits for cell collection, lymphodepletion, infusion, and monitoring
Duration - Up to 54 weeks after cell retransfusion
Participants are monitored for safety, tolerability, and efficacy outcomes for up to 54 weeks after cell retransfusion.
Regular follow-up visits for safety and efficacy assessments
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
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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