SarcomaPhase 1NCT06942143
An Open-label, Phase I Clinical Trial of Super1 TCR-T in NY-ESO-1-positive Patients With Advanced Solid Tumors
A Phase 1 study testing Super1 TCR-T in people with Sarcoma and Lung Cancers, run by Guangzhou FineImmune Biotechnology Co., LTD. at 1 site in China.
Trial summary
This study was a phase I safety and tolerability clinical trial conducted in a single-center, open-label, 3+3 design with dose escalation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sarcoma, Lung Cancers, Melanoma
- What is being tested?
- Super1 TCR-T
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 22 May 2025to 25 Jun 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 informed consent before conducting any trial-related activities;
- Age of 18-75 years old, male or female;
- Patients with first-line treatment failure;
- Measurable lesions according to RECIST1.1 criteria.
- During the trial screening period, the following two screening criteria must be met (by the sponsor) :
- HLA-A*02 positive;
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- The positive rate of NYESO-1 immunohistochemical staining was ≥20%.
- ECOG score 0-1;
- The expected survival time is more than 3 months;
- Antineoplastic drugs and treatments were not allowed for 4 weeks before TCR-T cell infusion;
- Echocardiography showed left ventricular ejection fraction ≥50%;
- Laboratory test results should at least meet the following specified indicators:
- WBC ≥3.0×109/L;
- Absolute neutrophil count (ANC) ≥1.5×109/L;
- Absolute lymphocyte count (ALC) ≥1.0×109/L;
- platelet (PLT) ≥75×109/L;
- hemoglobin ≥10g/dL (no blood transfusion in the past 7 days);
- Prothrombin time or INR≤1.5x upper limit of normal unless receiving anticoagulant therapy;
- Partial prothrombin time (APTT) ≤1.5x upper limit of normal time, unless receiving anticoagulant therapy;
- 24-hour creatinine clearance ≥60mL/ min;
- Aspartate aminotransferase (AST/SGOT) ≤2.5×ULN;
- alanine aminotransferase (ALT/SGPT) ≤2.5×ULN;
- Total bilirubin (TBIL) ≤1.5×ULN
- Negative pregnancy tests in women of childbearing potential prior to study treatment; Consent must be given to use effective contraception during treatment.
- During the whole period of the trial, I can regularly visit the enrolled research institutions for relevant testing, evaluation and management.
Who cannot join
- Patients who received major surgery, conventional chemotherapy, large area radiotherapy, immunotherapy or biological therapy within 4 weeks before entering the trial;
- Known to produce allergic reactions to any component of the trial treatment;
- no recovery from previous surgery or treatment-related adverse events to ≤ grade 2 CTCAE;
- Poorly controlled hypertension (systolic blood pressure > 160mmHg and/or diastolic blood pressure > 90mmHg) or clinically significant (e.g., active) cardio-cerebrovascular disease; Cerebrovascular accident (within 6 months before the signing of informed consent), myocardial infarction (within 6 months before the signing of informed consent), unstable angina, congestive heart failure of New York Heart Association class II or higher (Appendix), or severe arrhythmia that could not be controlled with medications or that had the potential to affect study treatment; Electrocardiogram (ECG) was significantly abnormal or the mean QTc interval was ≥450 msec on three consecutive occasions.
- Combined with other serious organic diseases and mental disorders;
- Have active systemic infection requiring treatment, including active tuberculosis, known HIV positivity, or clinically active hepatitis A, B, or C; (Virus carriers should be excluded)
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- Patients with autoimmune diseases: those with a history of inflammatory bowel disease or a history of autoimmune diseases (such as systemic lupus erythematosus, vasculitis, and invasive lung disease) judged by the investigators to be not suitable for this study should be excluded; (Patients with vitiligo are not excluded).
- Administration of chronic systemic cortisone steroids, hydroxyurea, and immunomodulatory agents (e.g., interleukin-2, interferon-α or γ, GM-CSF, mTOR inhibitors, cyclosporine, thymosin, etc.) within 4 weeks prior to cell therapy."
- History of organ transplantation, autologous/allogeneic stem cell transplantation and renal replacement therapy;
- Known uncontrolled diabetes mellitus, pulmonary fibrosis, interstitial lung disease, acute lung disease or liver failure;
- Known alcohol and/or drug abuse;
- Pregnant or lactating women;
- Trial participants with any coexisting medical conditions or diseases judged by the investigators to be likely to impair the conduct of the trial;
- No legal capacity/limited capacity.
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
Xing Zhang, Professor, 020-87343629, zhangxing@sysucc.org.cn
About this study
Official title: An Open-label, Phase I Clinical Trial of Autologous T Cells Transduced With NY-ESO-1 Antigen-specific High-affinity T Cell Receptors in NY-ESO-1-positive Patients With Advanced Solid Tumors
This study was a phase I safety and tolerability clinical trial conducted in a single-center, open-label, 3+3 design with dose escalation.
Read the detailed description
After the subjects signed the informed consent form, the HLA genotype of the subjects was detected. After the HLA genotype was confirmed as A*02, the tumor tissue was detected by immunohistochemistry. The subjects could proceed to the subsequent clinical trial if the NY-ESO-1 immunohistochemistry was positive. Each subject received only one cell reinfusion.
- Conditions
- Sarcoma, Lung Cancers, Melanoma
- Being tested
- Super1 TCR-T
- Keywords
- Cell therapy, Immunotherapy, Solid tumor, NY-ESO-1 TCR-T
- Medical subject headings
- Sarcoma, Lung Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Super1 TCR-TBiological
Also called NY-ESO-1 TCR-T
All participators received lymphoid-depleted preconditioning before Super1 TCR-T cells infusion. Super1 TCR-T cells were infused 3 days later. Concomitant administration of interleukin for 7 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation was performed in a 3+3 design | Experimental | The Super1 TCR-T dose toxicity test was escalated according to the following dose (positive cells) escalation schedule:
Level 1 Level 2 Level 3 Receives: Biological: Super1 TCR-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
Determining the dose-limiting toxicity (DLT) of Super1 TCR-T adoptive Immunotherapy
Measured: Up to 28 Days
MDT
Determining the maximum Tolerated dose (MTD) of Super1 TCR-T adoptive Immunotherapy
Measured: Up to 28 Days
Secondary outcomes (3)
ORR
Objective response rate,defined as the proportion of subjects with a confirmed PR or better best response
Measured: One year after cell reinfusion
OS
overall survival，time from subject's treatment to death. Participants with no death recorded at the time of statistical analysis were censored at the time of the last follow-up. In cases of loss to follow-up, data were censored at the date of the last contact with the participant.
Measured: One year after cell reinfusion
PFS
progression-free survival ，the time from the subject's treatment to the occurrence of PD or death from any cause, whichever occurred first. If no event (PD or death) occurred, the date of the last response assessment was the censored time for PFS.
Measured: One year after cell reinfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start22 May 2025
- Primary completion25 Apr 2027 (estimated)
- Study completion25 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies 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
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 15 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06942143
- Sponsor's protocol ID
- FIT002-IIT
- Status last verified
- Apr 2025
- First submitted
- 25 Mar 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase I Clinical Trial of Autologous T Cells Transduced With NY-ESO-1 Antigen-specific High-affinity T Cell Receptors in NY-ESO-1-positive Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06942143
- Acronym / sponsor ID
- FIT002-IIT
- Conditions
- Sarcoma, Lung Cancers, Melanoma
- Keywords
- Cell therapy, Immunotherapy, Solid tumor, NY-ESO-1 TCR-T
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Guangzhou FineImmune Biotechnology Co., LTD.Industry (pharma, biotech, devices)
- Collaborators
- Sun Yat-Sen University Cancer Center
- Study start
- 22 May 2025 (actual)
- Primary completion
- 25 Apr 2027 (estimated)
- Study completion
- 25 Jun 2027 (estimated)
- First posted
- 24 Apr 2025 (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.
This study was a phase I safety and tolerability clinical trial conducted in a single-center, open-label, 3+3 design with dose escalation.
Detailed description
After the subjects signed the informed consent form, the HLA genotype of the subjects was detected. After the HLA genotype was confirmed as A*02, the tumor tissue was detected by immunohistochemistry. The subjects could proceed to the subsequent clinical trial if the NY-ESO-1 immunohistochemistry was positive. Each subject received only one cell reinfusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Dose escalation was performed in a 3+3 design | Experimental | Biological: Super1 TCR-TThe Super1 TCR-T dose toxicity test was escalated according to the following dose (positive cells) escalation schedule: Level 1 Level 2 Level 3 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Sign informed consent before conducting any trial-related activities;
- Age of 18-75 years old, male or female;
- Patients with first-line treatment failure;
- Measurable lesions according to RECIST1.1 criteria.
- During the trial screening period, the following two screening criteria must be met (by the sponsor) :
Key exclusion criteria (14 listed)
- Patients who received major surgery, conventional chemotherapy, large area radiotherapy, immunotherapy or biological therapy within 4 weeks before entering the trial;
- Known to produce allergic reactions to any component of the trial treatment;
- no recovery from previous surgery or treatment-related adverse events to ≤ grade 2 CTCAE;
- Poorly controlled hypertension (systolic blood pressure > 160mmHg and/or diastolic blood pressure > 90mmHg) or clinically significant (e.g., active) cardio-cerebrovascular disease; Cerebrovascular accident (within 6 months before the signing of informed consent), myocardial infarction (within 6 months before the signing of informed consent), unstable angina, congestive heart failure of New York Heart Association class II or higher (Appendix), or severe arrhythmia that could not be controlled with medications or that had the potential to affect study treatment; Electrocardiogram (ECG) was significantly abnormal or the mean QTc interval was ≥450 msec on three consecutive occasions.
- Combined with other serious organic diseases and mental disorders;
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 |
|---|---|---|
| Super1 TCR-TAlso: NY-ESO-1 TCR-TAll participators received lymphoid-depleted preconditioning before Super1 TCR-T cells infusion. Super1 TCR-T cells were infused 3 days later. Concomitant administration of interleukin for 7 consecutive days. | Biological | Dose escalation was performed in a 3+3 design |
Primary outcome
DLT
Time frame: Up to 28 Days
Determining the dose-limiting toxicity (DLT) of Super1 TCR-T adoptive Immunotherapy
MDT
Time frame: Up to 28 Days
Determining the maximum Tolerated dose (MTD) of Super1 TCR-T adoptive Immunotherapy
3 secondary outcomes
ORR
Time frame: One year after cell reinfusion
OS
Time frame: One year after cell reinfusion
PFS
Time frame: One year after cell reinfusion
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 Sep 2025.
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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 Super1 TCR-T in people with Sarcoma and Lung Cancers, 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 25 inclusion and 14 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 3 Sep 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 (86-02031605836 ext. 08613535517727, 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: Up to 28 Days). The study lists 2 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 Sep 2025.