Advanced Solid TumorPhase 1TAL-TNCT06302062
Phase I Clinical Study of Tumor-associated Lymph Node T Cell Therapy for Advanced Solid Tumors
A Phase 1 study testing Tumor Associated Lymph node T cell, cyclophosphamide and IL-2 in people with Advanced Solid Tumor and Tumor Associated Lymph Node T Cell, run by Guangzhou FineImmune Biotechnology Co., LTD. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor, Tumor Associated Lymph Node T Cell, Immunotherapy
- What is being tested?
- Tumor Associated Lymph node T cell, cyclophosphamide and IL-2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2023to 30 Jun 2026
- 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
Before conducting tumor-associated lymph node sampling, it is necessary to verify that subjects meet the inclusion criteria marked with an asterisk (*). These criteria include:
- * being between the ages of 18 and 75;
- having metastatic or locally advanced refractory/recurrent malignant solid tumors that have failed standard therapy or have failed to tolerate standard treatment;
- having at least one measurable target lesion;
- * voluntarily participating and signing an informed consent form;
- * having at least one resectable tumor-associated lymph node from which T cells can be successfully isolated;
- * having an ECOG score of 0-1;
- * having an expected survival of more than 6 months;
- * 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;
- * being willing to regularly come to the hospital for treatment, testing, evaluation, and management as required during the entire study period.
Before sampling tumor-associated lymph nodes, it is important to confirm that the subject does not meet any of the exclusion criteria marked with an asterisk (*). These criteria include:
- * Experiencing moderate to severe infection or at risk of opportunistic infection;
- * Present with active autoimmune disease (other than vitiligo or childhood asthma/allergies that have healed);
- * Uncontrolled concomitant disease, including but not limited to symptomatic congestive heart failure, unstable angina pectoris, arrhythmias (excluding stable atrial fibrillation), and significant carotid stenosis.
- * Acute systemic infections, coagulation disorders or other serious cardiopulmonary diseases;
- Patients who have used large amounts of glucocorticoids or other immunosuppressants within 4 weeks;
- * A history of severe hypersensitivity to any of the drugs used in this study;
- Known uncontrolled central nervous system (CNS) metastases and/or cancerous meningitis;
- * Pregnant and lactating women, as well as women and men who were unable to cooperate with contraception during the study period;
- 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;
- * 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;
- * Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
- * 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;
- * Known history of primary immunodeficiency virus infection or positive HIV test;
- * Patients with chronic hepatitis B or HBV carriers of chronic hepatitis B virus (HBV), or patients with active hepatitis C should be excluded;
- * Any of the following cardiovascular diseases
- have evidence of acute or persistent episodes of myocardial ischemia;
- symptomatic pulmonary embolism is present;
- acute myocardial infarction occurred within 6 months prior to the initial study treatment;
- 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;
- Occurrence of grade 2 or more ventricular arrhythmias within 6 months prior to the first study treatment;
- cerebrovascular accident or transient ischemic stroke occurred within 6 months prior to the first study treatment
- * Subjects with pleural effusion, pericardial effusion, or ascites that, in the investigator\'s judgment, cannot be stably controlled by repeated drainage or other methods;
- Have received a live vaccine within 30 days prior to the first dose or plan to receive a live vaccine during the study period;
- * Disease known to produce severe hypersensitivity to other monoclonal antibodies;
- 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;
- * With a second primary tumor (within 5 years).
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: An Open,Single-center,Phase I Clinical Study of Tumor-associated Lymph Node T Cell Therapy for Advanced Solid Tumors
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.
Read the detailed description
This is an open, single-center Phase I clinical trial designed to assess the safety, tolerability, efficacy, and feasibility of tumor-associated lymph node T cells (TAL-T) for treating metastatic solid tumors. The study consists of three distinct phases: screening, administration of treatment, and follow-up evaluation. In this investigation, TAL-T cells will be cultured after being separated in a laboratory setting. Participants will receive 1-2 infusions of TAL-T cells.
- Being tested
- Tumor Associated Lymph node T cell, cyclophosphamide, IL-2, Serplulimab Injection
- Keywords
- TAL-T, cell therapy, Tumor Associated Lymph node T cell, Safety, Adverse Drug Event, Efficacy, Immunotherapy, Serplulimab Injection
- 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 cellDrug
Also called TAL-T cells, TAL-T
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.
cyclophosphamideDrug
A one-day intravenous injection of cyclophosphamide was administered two days prior to the initial cell transfusion.
IL-2Drug
Also called Cellular interleukin 2, interleukin-2
The IL-2 treatment will be continued for 5 days.
Serplulimab InjectionDrug
Also called PD1 monoclonal antibody, PD1
In group B, Serplulimab Injection was injected before and after cell transfusion. If two cell transfusions were performed,Serplulimab Injection were given again .
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Three patients were planned to be enrolled, and each subject received one to two cell transfusions. Receives: Drug: Tumor Associated Lymph node T cell; Drug: cyclophosphamide; Drug: IL-2 |
| Cohort B | Experimental | 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. Receives: Drug: Tumor Associated Lymph node T cell; Drug: cyclophosphamide; Drug: IL-2; Drug: Serplulimab Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
The dosage of TAL-T was determined to limit toxicity
Measured: At least 58 days
MDT
Determine the maximum tolerated dose of TAL-T
Measured: At least 58 days
Number of participants with treatment-related adverse events as assessed by CTCAE V4.03
Keep record the adverse eventd experienced by subjects in 30 days after the last infusion
Measured: At least 60 days
Secondary outcomes (3)
ORR
The proportion of subjects receiving a confirmed optimal response of PR or above which was evaluation according to RECIST or iRECIST principles.
Measured: one yaer
PFS
The time between the subject receiving treatment and the onset of PD or death from any cause, whichever occurs first. If the subject had no events (PD or death), the last response assessment day was the cut-off time for PFS.
Measured: two years
life quality score
ECOG 0-1
Measured: At least 70 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start6 Jun 2023
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou FineImmune Biotechnology Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302062
- Sponsor's protocol ID
- FIT003-IIT
- Acronym
- TAL-T
- Status last verified
- Nov 2024
- First submitted
- 4 Mar 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open,Single-center,Phase I Clinical Study of Tumor-associated Lymph Node T Cell Therapy for Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06302062
- Acronym / sponsor ID
- TAL-T / FIT003-IIT
- Keywords
- TAL-T, cell therapy, Tumor Associated Lymph node T cell, Safety, Adverse Drug Event, Efficacy, Immunotherapy, Serplulimab Injection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Guangzhou FineImmune Biotechnology Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 8 Mar 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 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.
Detailed description
This is an open, single-center Phase I clinical trial designed to assess the safety, tolerability, efficacy, and feasibility of tumor-associated lymph node T cells (TAL-T) for treating metastatic solid tumors. The study consists of three distinct phases: screening, administration of treatment, and follow-up evaluation. In this investigation, TAL-T cells will be cultured after being separated in a laboratory setting. Participants will receive 1-2 infusions of TAL-T cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: Tumor Associated Lymph node T cell, Drug: cyclophosphamide, Drug: IL-2Three patients were planned to be enrolled, and each subject received one to two cell transfusions. |
| Cohort B | Experimental | Drug: Tumor Associated Lymph node T cell, Drug: cyclophosphamide, Drug: IL-2, Drug: Serplulimab Injection14 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 cells, TAL-TAt 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. | Drug | Cohort A, Cohort B |
| cyclophosphamideA one-day intravenous injection of cyclophosphamide was administered two days prior to the initial cell transfusion. | Drug | Cohort A, Cohort B |
| IL-2Also: Cellular interleukin 2, interleukin-2The IL-2 treatment will be continued for 5 days. | Drug | Cohort A, Cohort B |
| Serplulimab InjectionAlso: PD1 monoclonal antibody, PD1In group B, Serplulimab Injection was injected before and after cell transfusion. If two cell transfusions were performed,Serplulimab Injection were given again . | Drug | Cohort B |
Primary outcome
DLT
Time frame: At least 58 days
The dosage of TAL-T was determined to limit toxicity
MDT
Time frame: At least 58 days
Determine the maximum tolerated dose of TAL-T
Number of participants with treatment-related adverse events as assessed by CTCAE V4.03
Time frame: At least 60 days
Keep record the adverse eventd experienced by subjects in 30 days after the last infusion
3 secondary outcomes
ORR
Time frame: one yaer
PFS
Time frame: two years
life quality score
Time frame: At least 70 days
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 3 Dec 2024.
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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, cyclophosphamide and IL-2 in people with Advanced Solid Tumor and Tumor Associated Lymph Node T Cell, 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?
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 3 Dec 2024. 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 (86-020-31605836, chengy02@fineimmu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: At least 58 days). The study lists 3 primary outcomes in all. 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 3 Dec 2024.