Solid TumorPhase 1NCT03891706
Individualized Tumor Specific TCR- T Cells in the Treatment of Advanced Solid Tumors
A Phase 1 study testing tumor-specific TCR-T cells and Interleukin-2 in people with Solid Tumor, run by Guangzhou FineImmune Biotechnology Co., LTD. at 1 site in China.
Trial summary
The primary purpose of this study is to evaluate the safety of the tumor-specific TCR-T cells in the treatment of advanced Solid Tumor . The secondary purpose of this study is to preliminarily showed the effect of TCR-T cells in the treatment of advanced Solid Tumor . Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- tumor-specific TCR-T cells and Interleukin-2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 8 Jan 2019to 31 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 70 years old, regardless of gender;
- Diagnosed as solid tumors by histopathology, and the tumor lesions could be detected or evaluated;
- Be after standard treatment or who lack effective treatment programs;
- Patients and their families were willing to participate in the clinical trial and signed the informed consent;
- Physical status: ECOG score 0-1;
- Expected survival time > 3 months;
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- HIV antibody negative;Hepatitis b surface antigen negative;Hepatitis c antibody negative;The results of blood routine and coagulation were roughly normal, lymphocyte >0.8×10^9/L, hemoglobin >100g/L, and the pregnancy test of female patients with fertility potential was negative.
- Left ventricular ejection fraction 50% as indicated by cardiac ultrasound;Upper normal level of serum ALT/AST < 2.5 times;Serum creatinine 1.6mg/dl;Total bilirubin 1.5mg/dl, subject's total bilirubin < 3mg/dl except for Gilberts Syndrome;
- At least 4 weeks after the last systemic treatment, the patient's toxic and side effects must be restored to grade 1 or lower (except for alopecia or vitiligo).If the subject undergoes minor surgery within 3 weeks prior to enrollment, as long as all toxicity is recovered to level 1 or lower, the subject will meet the enrollment requirements.
- During the whole study period, patients can regularly visit the enrolled research institutions for relevant detection, evaluation and management;
- The patient is not allowed to use any anti-tumor drugs or treatments for 4 weeks prior to the infusion of TCR-T cells;
- Patients' tumor lesions can be obtained by surgery or puncture, and tumor infiltrating T cells can be successfully isolated from the obtained tumor tissue;
- T cells in patients' peripheral blood can effectively proliferate and expand by at least 10 times in the Pre-culture;
- The benefits of participating in the clinical trial outweigh the risks,which was evaluated by the researchers base on the status or condition of the patients.
Who cannot join
- Any form of primary immunodeficiency disease (such as severe combined immunodeficiency disease);
- Experiencing moderate to severe infection or possible opportunistic infection;
- Patients with a history of autoimmunity (e.g., SLE, psoriasis, etc.);
- Acute systemic infection, coagulation dysfunction or other serious cardiopulmonary diseases;
- Patients who have is suffering a large amount of glucocorticoid or other immunosuppressive agents within 4 weeks;
- Be allergic to any drug used in this study;
- Central nervous system metastases patients with clinically unstable or acute meningitis (except these clinically stable after treatment) Clinical stability needs to be met as follows: 4 weeks at least before the trial treatment, 1) no new brain lesion or no expanded of the original lesions confirmed by MRI); 2) no hormone therapy for at least 2 weeks; 3) neurological symptoms have returned to baseline;
- Pregnant and lactating women, as well as male and female patients who could not cooperate with contraception during the study period.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Gaungdong, 510700
Xuzhi Pan, 86-20-87343135, panxzh@sysucc.org.cn
Xiaoshi Zhang, professor
About this study
Official title: An Open, Single-center, Stage I Clinical Study of Individualized Tumor Specific TCR-T Cells in the Treatment of Advanced Solid Tumors.
The primary purpose of this study is to evaluate the safety of the tumor-specific TCR-T cells in the treatment of advanced Solid Tumor .
The secondary purpose of this study is to preliminarily showed the effect of TCR-T cells in the treatment of advanced Solid Tumor .
Read the detailed description
This study is an open, single-center, phase I clinical trial which is aim to evaluate the safety and tolerability of tumor-specific TCR-T cells. In this study, these TCR-T cells will be multiplied, or grown, in the laboratory.Subjects will received TCR-T cells infusions twice at day 0 and day 14, with the use of IL-2 for 5 consecutive days after every cell infusion.
- Conditions
- Solid Tumor
- Being tested
- tumor-specific TCR-T cells, Interleukin-2
- Keywords
- TCR-T
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tumor-specific TCR-T cellsDrug
Also called TCR-T cells, FIT-001
On day 0 and day 14, 0.5-5x10^9 TCR-T cells will be infused intravenously (IV) over 1 hour,patients may choose to receive more cell infusions if they benefit from the treatment.
Interleukin-2Drug
Also called IL-2
Aldesleukin 3,000,000 IU. IV.QD beginning within 24 hours of cell infusion and continuing for up to 5 days .
| Study group | Role | What they receive |
|---|---|---|
| TCR-T cell infusion | Experimental | Patient will exposed to Individualized Tumor-t Cell Receptor (TCR) -Mediated T Cells therapy Receives: Drug: tumor-specific TCR-T cells; Drug: Interleukin-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Keep records the adverse events experienced by subjects in 30 days after the last infusion.
Measured: At least 45 days
Secondary outcomes (3)
Disease Control Rate(DCR)
DCR is defined as the proportion of patients with tumor size reduction(CR,PR) and stable (SD) assessed by RECIST 1.1 and iRECIST
Measured: one year
overall survival(OS)
The time from the first injection of Investigational Product until death
Measured: two year
progression-free survival(PFS)
PFS is defined as the time from the first injection of Investigational Product until objective tumor progression or death, whichever occurs first.Assessed by RECIST 1.1 and iRECIST
Measured: two year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start8 Jan 2019
- Primary completion1 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou FineImmune Biotechnology Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sun Yat-Sen University Cancer Center
- Responsible party
- Sponsor
- Investigators
- Penghui Zhou, Study director, Guangzhou FineImmune Biotechnology Co., LTD.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03891706
- Sponsor's protocol ID
- FI-FIT001-001
- Status last verified
- Sep 2024
- First submitted
- 24 Mar 2019
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Single-center, Stage I Clinical Study of Individualized Tumor Specific TCR-T Cells in the Treatment of Advanced Solid Tumors.
- ClinicalTrials.gov ID
- NCT03891706
- Acronym / sponsor ID
- FI-FIT001-001
- Conditions
- Solid Tumor
- Keywords
- TCR-T
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Guangzhou FineImmune Biotechnology Co., LTD.Industry (pharma, biotech, devices)
- Collaborators
- Sun Yat-Sen University Cancer Center
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Mar 2019 (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.
The primary purpose of this study is to evaluate the safety of the tumor-specific TCR-T cells in the treatment of advanced Solid Tumor .
The secondary purpose of this study is to preliminarily showed the effect of TCR-T cells in the treatment of advanced Solid Tumor .
Detailed description
This study is an open, single-center, phase I clinical trial which is aim to evaluate the safety and tolerability of tumor-specific TCR-T cells. In this study, these TCR-T cells will be multiplied, or grown, in the laboratory.Subjects will received TCR-T cells infusions twice at day 0 and day 14, with the use of IL-2 for 5 consecutive days after every cell infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TCR-T cell infusion | Experimental | Drug: tumor-specific TCR-T cells, Drug: Interleukin-2Patient will exposed to Individualized Tumor-t Cell Receptor (TCR) -Mediated T Cells therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Aged between 18 and 70 years old, regardless of gender;
- Diagnosed as solid tumors by histopathology, and the tumor lesions could be detected or evaluated;
- Be after standard treatment or who lack effective treatment programs;
- Patients and their families were willing to participate in the clinical trial and signed the informed consent;
- Physical status: ECOG score 0-1;
Key exclusion criteria (8 listed)
- Any form of primary immunodeficiency disease (such as severe combined immunodeficiency disease);
- Experiencing moderate to severe infection or possible opportunistic infection;
- Patients with a history of autoimmunity (e.g., SLE, psoriasis, etc.);
- Acute systemic infection, coagulation dysfunction or other serious cardiopulmonary diseases;
- Patients who have is suffering a large amount of glucocorticoid or other immunosuppressive agents within 4 weeks;
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-specific TCR-T cellsAlso: TCR-T cells, FIT-001On day 0 and day 14, 0.5-5x10^9 TCR-T cells will be infused intravenously (IV) over 1 hour,patients may choose to receive more cell infusions if they benefit from the treatment. | Drug | TCR-T cell infusion |
| Interleukin-2Also: IL-2Aldesleukin 3,000,000 IU. IV.QD beginning within 24 hours of cell infusion and continuing for up to 5 days . | Drug | TCR-T cell infusion |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Time frame: At least 45 days
Keep records the adverse events experienced by subjects in 30 days after the last infusion.
3 secondary outcomes
Disease Control Rate(DCR)
Time frame: one year
overall survival(OS)
Time frame: two year
progression-free survival(PFS)
Time frame: two year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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. This study is not recruiting at the moment.
Penghui Zhou study director
Guangzhou FineImmune Biotechnology Co., LTD.
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-specific TCR-T cells and Interleukin-2 in people with 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 14 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 19 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuzhi Pan (86-20-87343135, panxzh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 (time frame: At least 45 days). 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 19 Sep 2024.