Phase I Clinical Study of Tumor-associated Lymph Node T Cell Therapy for Advanced Solid Tumors
NCT ID: NCT06302062
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
23 participants
INTERVENTIONAL
2023-06-06
2026-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort A
Three patients were planned to be enrolled, and each subject received one to two cell transfusions.
Tumor Associated Lymph node T cell
At least one lymph sample is resected from each participant, then it is separated and cultured ex vivo to expand the population of Tumor Associated Lymph node T cells (FIT003 TAL-T). After lymphodepletion, patients are infused with FIT003 TAL-T.
cyclophosphamide
A one-day intravenous injection of cyclophosphamide was administered two days prior to the initial cell transfusion.
IL-2
The IL-2 treatment will be continued for 5 days.
Cohort B
14 to 20 patients were enrolled, and each subject received one to two cell transfusions. In this group, Tumor Associated Lymph node T cells were combined with Serplulimab Injection.
Tumor Associated Lymph node T cell
At least one lymph sample is resected from each participant, then it is separated and cultured ex vivo to expand the population of Tumor Associated Lymph node T cells (FIT003 TAL-T). After lymphodepletion, patients are infused with FIT003 TAL-T.
cyclophosphamide
A one-day intravenous injection of cyclophosphamide was administered two days prior to the initial cell transfusion.
IL-2
The IL-2 treatment will be continued for 5 days.
Serplulimab Injection
In group B, Serplulimab Injection was injected before and after cell transfusion. If two cell transfusions were performed,Serplulimab Injection were given again .
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tumor Associated Lymph node T cell
At least one lymph sample is resected from each participant, then it is separated and cultured ex vivo to expand the population of Tumor Associated Lymph node T cells (FIT003 TAL-T). After lymphodepletion, patients are infused with FIT003 TAL-T.
cyclophosphamide
A one-day intravenous injection of cyclophosphamide was administered two days prior to the initial cell transfusion.
IL-2
The IL-2 treatment will be continued for 5 days.
Serplulimab Injection
In group B, Serplulimab Injection was injected before and after cell transfusion. If two cell transfusions were performed,Serplulimab Injection were given again .
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. having metastatic or locally advanced refractory/recurrent malignant solid tumors that have failed standard therapy or have failed to tolerate standard treatment;
3. having at least one measurable target lesion;
4. \* voluntarily participating and signing an informed consent form;
5. \* having at least one resectable tumor-associated lymph node from which T cells can be successfully isolated;
6. \* having an ECOG score of 0-1;
7. \* having an expected survival of more than 6 months;
8. \* female subjects with fertility potential must have a negative pregnancy test, and all men and women with fertility potential must consent to using medically effective contraception during the study period and for 12 months after the last dose of the study medication;
9. \* being willing to regularly come to the hospital for treatment, testing, evaluation, and management as required during the entire study period.
Exclusion Criteria
2. \* Present with active autoimmune disease (other than vitiligo or childhood asthma/allergies that have healed);
3. \* Uncontrolled concomitant disease, including but not limited to symptomatic congestive heart failure, unstable angina pectoris, arrhythmias (excluding stable atrial fibrillation), and significant carotid stenosis.
4. \* Acute systemic infections, coagulation disorders or other serious cardiopulmonary diseases;
5. Patients who have used large amounts of glucocorticoids or other immunosuppressants within 4 weeks;
6. \* A history of severe hypersensitivity to any of the drugs used in this study;
7. Known uncontrolled central nervous system (CNS) metastases and/or cancerous meningitis;
8. \* Pregnant and lactating women, as well as women and men who were unable to cooperate with contraception during the study period;
9. Previous anti-tumor therapy: within four weeks of radiotherapy, chemotherapy, one week after TKI inhibitor treatment, four weeks of investigational therapy or four half-lives, whichever is shorter;
10. \* Enroll in another clinical study at the same time, unless it is an observational, non-interventional clinical study or the follow-up period of an interventional study;
11. \* Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
12. \* Known history of interstitial lung disease. Exclude subjects with high suspicion of interstitial pneumonia; Or may interfere with the detection or management of suspected drug-related pulmonary toxicity; Or other moderate to severe lung diseases that seriously affect lung function;
13. \* Known history of primary immunodeficiency virus infection or positive HIV test;
14. \* Patients with chronic hepatitis B or HBV carriers of chronic hepatitis B virus (HBV), or patients with active hepatitis C should be excluded;
15. \* Any of the following cardiovascular diseases
1. have evidence of acute or persistent episodes of myocardial ischemia;
2. symptomatic pulmonary embolism is present;
3. acute myocardial infarction occurred within 6 months prior to the initial study treatment;
4. symptomatic congestive heart failure (grade 3 or 4 according to the New York Heart Association Functional Scale) occurred within 6 months prior to the first study treatment;
5. Occurrence of grade 2 or more ventricular arrhythmias within 6 months prior to the first study treatment;
6. cerebrovascular accident or transient ischemic stroke occurred within 6 months prior to the first study treatment
16. \* Subjects with pleural effusion, pericardial effusion, or ascites that, in the investigator\'s judgment, cannot be stably controlled by repeated drainage or other methods;
17. Have received a live vaccine within 30 days prior to the first dose or plan to receive a live vaccine during the study period;
18. \* Disease known to produce severe hypersensitivity to other monoclonal antibodies;
19. Any condition that the investigator believes may result in a risk of acceptance of the study drug treatment or interfere with the evaluation of the study drug or the safety of the subjects or the interpretation of the study results;
20. \* With a second primary tumor (within 5 years).
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Guangzhou FineImmune Biotechnology Co., LTD.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sun Yat-sen University Cancer Center
Guangzhou, Gaungdong, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Xiaoshi Zhang
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FIT003-IIT
Identifier Type: -
Identifier Source: org_study_id