Tumor Associated Lymph Node T CellPhase 1NCT06716619
A Phase I Trial of Tumor-Associated Lymph Node T-Cell Injection With Advanced Malignant Solid Tumors
A Phase 1 study testing Tumor Associated Lymph node T cell and Serplulimab Injection in people with Tumor Associated Lymph Node T Cell and Advanced Solid Tumor, run by Guangzhou FineImmune Biotechnology Co., LTD. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tumor Associated Lymph Node T Cell, Advanced Solid Tumor, Immunotherapy
- What is being tested?
- Tumor Associated Lymph node T cell and Serplulimab Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 13 Feb 2025to 19 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign a written informed consent (ICF) and be able to comply with the visit and related procedures required by the program;
- Age ≥18 years old, and ≤75 years old, male and female;
- ECOG score 0-1;
- Expected survival is not less than 12 weeks;
- Advanced malignant solid tumors confirmed by cytology or histopathology (tumor markers combined with imaging can be used for some special advanced tumors, such as liver cancer) that have failed standard treatment or lack effective treatment methods, including but not limited to melanoma, head and neck tumors, cervical cancer, non-small cell lung cancer, etc.
- "Standard treatment failure" refers to the occurrence of disease progression after enough treatment courses and sufficient lines of treatment with the existing standard recommended therapy (refer to the latest CSCO guidelines), or recurrence after the regression of the tumor after standard treatment, or the toxic side effects of standard treatment are not tolerated.
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- There are tumor-associated lymph nodes that can be resected and T cells can be isolated: the tissue taken is ≥1 cm3, and the site has not received local treatment or has progressed after local treatment;
- After sampling, subjects still have at least one evaluable lesion (Extended enrollment phase according to RECIST v1.1, subjects still have at least one measurable lesion (lesions that have received local treatment such as radiotherapy, interventional therapy, etc., cannot be considered as measurable lesions unless imaging evidence confirms clear progression of the lesion). That is, CT or MRI examination of non-lymph node lesions with the longest diameter ≥10 mm, and/or lymph node lesions with a short diameter ≥15 mm);
- The subject has sufficient organ and bone marrow function (no blood transfusion or hematopoietic stimulating factors can be received within 14 days prior to screening)
- Fertile men and women of reproductive age must agree to use effective contraception from the time they sign the ICF until one year after cell transfusion, and women of reproductive age must have a negative blood pregnancy test at the time of screening.
Who cannot join
- meningeal metastases, and/or active brain metastases;
- Have previously received allogeneic bone marrow transplantation, organ transplantation or are waiting for transplantation;
- HBsAg positive hepatitis B; HCV-Ab positive hepatitis C; Positive for human immunodeficiency virus (HIV) antibodies; Syphilis antibody positive; Cytomegalovirus (CMV) IgM antibody positive; Human herpesvirus type 4 (EBV) IgM positive; Human T-lymphocytophilic virus (HTLV-Ⅰ/Ⅱ) antibody positive;
- Received any fluorouracil chemotherapeutic drugs or small molecule targeted drugs within 14 days or 5 half-lives (whichever is shorter) prior to pretreatment; Received any antitumor biologic or non-fluorouracil chemotherapeutic drugs within 28 days or 5 half-lives (whichever is shorter) prior to pretreatment; Received radical radiotherapy or extensive radiotherapy within 28 days prior to pretreatment (except local non-target palliative radiotherapy for symptom relief within 14 days prior to pretreatment); Received Chinese medicine/Chinese herbal medicine with anti-tumor indications and local interventional therapy within 14 days prior to pretreatment;
- Adverse events resulting from previous antitumor therapy have not returned to grade 1 or baseline levels (except for alopecia, grade 2 peripheral neurotoxicity, hypothyroidism controlled by alternative therapy and other toxicities that the investigators judged to be of no safety risk);
- Persons who had been immunized with live attenuated vaccine within 28 days prior to pretreatment, or who required live attenuated vaccine immunization during the study period;
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- Had major surgery within 28 days prior to pretreatment, or required major surgery during the study period;
- Long-term (≥3 days) treatment with systemic corticosteroids (dose ≥10 mg/ day of prednisone or equivalent hormone) or other immunosuppressive agents, except for inhalation or local use, is required 7 days before the tumor-associated lymph node excision sampling or during the study period;
- Subjects with active systemic infections requiring intravenous antibiotic treatment within 7 days prior to screening;
- Patients with active or past autoimmune diseases that are likely to recurs, such as systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vasculitis, psoriasis, etc. (subjects with hypothyroidism requiring only thyroid hormone replacement therapy, and subjects with type 1 diabetes requiring only insulin replacement therapy can be enrolled);
- Previous or current cases of interstitial lung disease, coniosis, radiation pneumonia, severe impairment of lung function, etc.;
- Hepatic encephalopathy, hepatorenal syndrome or Child-Pugh grade B or more severe cirrhosis, liver failure;
- Third space effusion with poor clinical control before screening, such as pleural fluid and ascites that cannot be controlled by drainage or other methods;
- Have a history of severe cardiovascular and cerebrovascular disease
- Patients with pulmonary embolism or severe deep venous thrombosis of lower extremities during screening, requiring interventional therapy such as inferior vena cava filter placement, or using therapeutic dose of anticoagulants;
- Any CTCAE 5.0 immune-related adverse reactions (irAE) grade ≥3 during any prior immunotherapy;
- Those with immune checkpoints (such as PD-1) for treatment of other contraindications;
- Subjects are participating in other interventional clinical studies;
- Pregnant or lactating women;
- The investigator believes that the subjects have other conditions that may affect their compliance or are not suitable to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Gaungdong, 510700
Xiaoshi Zhang, 020-8734-3383
Xiaoshi Zhang, Professor
About this study
Official title: 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
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.
Read the detailed description
The study was divided into two phases, the dose-range exploration study and the expanded enrollment study.
Exploration of the dosage range phase and the expanded enrollment phase were designed to evaluate the safety, tolerability, and initial efficacy of TAL-T cell therapy in patients with advanced solid tumors
- Conditions
- Tumor Associated Lymph Node T Cell, Advanced Solid Tumor, Immunotherapy, Serplulimab Injection
- Being tested
- Tumor Associated Lymph node T cell, Serplulimab Injection
- Keywords
- Immunotherapy, Advanced Solid Tumor, Tumor Associated Lymph Node T Cell, TAL-T, cell therapy, Serplulimab Injection, Adverse Drug Event, Efficacy, Safety
- Medical subject headings
- Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor Associated Lymph node T cellBiological
Also called TAL-T, TAL-T cells
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 . After lymphodepletion, patients are infused with TAL-T.
Serplulimab InjectionDrug
Srulizumab injection was given intravenous infusion both before and after the TAL-T cells infusion.
| Study group | Role | What they receive |
|---|---|---|
| Exploration of the dosage range and Expansion phase | Experimental | In the exploration dosage range phase, the safety data accumulated from the trial will be used to evaluate whether the safety of TAL-T cell therapy meets the requirements and decide whether to terminate the study. Exploration of the dosage range is divided into three dose phases, and the upper limit of the maximum dose is constantly expanded.
After completion of exploration study, three types of preferred tumor will be choosed by sponsor. During the expansion phase, the actual number of participants in each cohort may be adjusted based on the obtained trial results to further evaluate the safety, tolerability, and efficacy of TAL-T cell infusion. Receives: Biological: Tumor Associated Lymph node T cell; Drug: Serplulimab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
AEs and SAEs
Incidence, severity and drug correlation of AEs and SAEs
Measured: All aes and saes are to be collected from the time the pre-screened informed consent is signed until 54 weeks after cell retransfusion, unless the subject withdraws from the study early for any reason
Secondary outcomes (5)
ORR
The proportion of subjects receiving a confirmed optimal response of PR or above which was evaluation according to RECIST or iRECIST principles.
Measured: Two years
DCR
The proportion of subjects whose response was assessed as CR, PR, or stable disease (SD) to the total number of subjects for which response could be assessed
Measured: Two years
DOR
The first assessment of efficacy was CR or PR up to PD or the time of death from any cause
Measured: Two years
PFS
The time from the beginning of preconditioning until disease progression (PD) or death from any cause
Measured: Two years
OS
The time from the subject's pre-treatment until death from any cause
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start13 Feb 2025
- Primary completion19 Dec 2026 (estimated)
- Study completion19 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor Associated Lymph Node T CellStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou FineImmune Biotechnology Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sun Yat-sen University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06716619
- Sponsor's protocol ID
- FIT003-001
- Status last verified
- Mar 2025
- First submitted
- 29 Nov 2024
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06716619
- Acronym / sponsor ID
- FIT003-001
- Conditions
- Tumor Associated Lymph Node T Cell, Advanced Solid Tumor, Immunotherapy, Serplulimab Injection
- Keywords
- Immunotherapy, Advanced Solid Tumor, Tumor Associated Lymph Node T Cell, TAL-T, cell therapy, Serplulimab Injection, Adverse Drug Event, Efficacy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Guangzhou FineImmune Biotechnology Co., LTD.Industry (pharma, biotech, devices)
- Collaborators
- Sun Yat-sen University
- Study start
- 13 Feb 2025 (actual)
- Primary completion
- 19 Dec 2026 (estimated)
- Study completion
- 19 Dec 2027 (estimated)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study was divided into two phases, the dose-range exploration study and the expanded enrollment study.
Exploration of the dosage range phase and the expanded enrollment phase were designed to evaluate the safety, tolerability, and initial efficacy of TAL-T cell therapy in patients with advanced solid tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exploration of the dosage range and Expansion phase | Experimental | Biological: Tumor Associated Lymph node T cell, Drug: Serplulimab InjectionIn the exploration dosage range phase, the safety data accumulated from the trial will be used to evaluate whether the safety of TAL-T cell therapy meets the requirements and decide whether to terminate the study. Exploration of the dosage range is divided into three dose phases, and the upper limit of the maximum dose is constantly expanded. After completion of exploration study, three types of preferred tumor will be choosed by sponsor. During the expansion phase, the actual number of participants in each cohort may be adjusted based on the obtained trial results to further evaluate the safety, tolerability, and efficacy of TAL-T cell infusion. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Sign a written informed consent (ICF) and be able to comply with the visit and related procedures required by the program;
- Age ≥18 years old, and ≤75 years old, male and female;
- ECOG score 0-1;
- Expected survival is not less than 12 weeks;
- Advanced malignant solid tumors confirmed by cytology or histopathology (tumor markers combined with imaging can be used for some special advanced tumors, such as liver cancer) that have failed standard treatment or lack effective treatment methods, including but not limited to melanoma, head and neck tumors, cervical cancer, non-small cell lung cancer, etc.
Key exclusion criteria (20 listed)
- meningeal metastases, and/or active brain metastases;
- Have previously received allogeneic bone marrow transplantation, organ transplantation or are waiting for transplantation;
- HBsAg positive hepatitis B; HCV-Ab positive hepatitis C; Positive for human immunodeficiency virus (HIV) antibodies; Syphilis antibody positive; Cytomegalovirus (CMV) IgM antibody positive; Human herpesvirus type 4 (EBV) IgM positive; Human T-lymphocytophilic virus (HTLV-Ⅰ/Ⅱ) antibody positive;
- Received any fluorouracil chemotherapeutic drugs or small molecule targeted drugs within 14 days or 5 half-lives (whichever is shorter) prior to pretreatment; Received any antitumor biologic or non-fluorouracil chemotherapeutic drugs within 28 days or 5 half-lives (whichever is shorter) prior to pretreatment; Received radical radiotherapy or extensive radiotherapy within 28 days prior to pretreatment (except local non-target palliative radiotherapy for symptom relief within 14 days prior to pretreatment); Received Chinese medicine/Chinese herbal medicine with anti-tumor indications and local interventional therapy within 14 days prior to pretreatment;
- Adverse events resulting from previous antitumor therapy have not returned to grade 1 or baseline levels (except for alopecia, grade 2 peripheral neurotoxicity, hypothyroidism controlled by alternative therapy and other toxicities that the investigators judged to be of no safety risk);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tumor Associated Lymph node T cellAlso: TAL-T, TAL-T cellsAt 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 . After lymphodepletion, patients are infused with TAL-T. | Biological | Exploration of the dosage range and Expansion phase |
| Serplulimab InjectionSrulizumab injection was given intravenous infusion both before and after the TAL-T cells infusion. | Drug | Exploration of the dosage range and Expansion phase |
Primary outcome
AEs and SAEs
Time frame: All aes and saes are to be collected from the time the pre-screened informed consent is signed until 54 weeks after cell retransfusion, unless the subject withdraws from the study early for any reason
Incidence, severity and drug correlation of AEs and SAEs
5 secondary outcomes
ORR
Time frame: Two years
DCR
Time frame: Two years
DOR
Time frame: Two years
PFS
Time frame: Two years
OS
Time frame: Two years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tumor Associated Lymph node T cell and Serplulimab Injection in people with Tumor Associated Lymph Node T Cell and Advanced Solid Tumor, run by Guangzhou FineImmune Biotechnology Co., LTD. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Cheng, Master (86-02031605836, chengy02@fineimmu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AEs and SAEs (time frame: All aes and saes are to be collected from the time the pre-screened informed consent is signed until 54 weeks after cell retransfusion, unless the subject withdraws from the study early for any reason). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.