Advanced Mesenchymal MalignanciesPhase 1NCT07467122

Exploratory Clinical Study of TCR-T for MAGE-A4-positive Mesenchymal Malignancies

A Phase 1 study testing TCR-T cells targeting MAGE-A4 in people with Advanced Mesenchymal Malignancies, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Advanced Mesenchymal Malignancies
What is being tested?: TCR-T cells targeting MAGE-A4
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: 15 Mar 2026to 31 Dec 2031
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

Voluntarily sign a written informed consent form;
Gender is not limited. Age range: 18 to 75 years old (including the critical value).
Has histopathologically confirmed advanced mesenchymal malignancies, including but not limited to malignant phyllodes tumors of the breast, soft tissue sarcomas, osteosarcomas, etc. Has recurrent tumors, metastatic tumors or locally advanced tumors that have progressed after treatment and cannot be surgically resected, and has failed or cannot tolerate at least one line of standard treatment.
Has at least one measurable lesion (per RECIST1.1);
The H-score of MAGE-A4 expression in the patient's tumor tissue detected by immunohistochemistry reached 30 points or above.
H-score = 1×(percentage of weakly positive cells) + 2×(percentage of moderately positive cells) + 3×(percentage of strongly positive cells), with a score range of 0 to 300.

Show all 26Show fewer

HLA-A*02 positive, except for the following situations:
① HLA-A02:05 in either allele; Or either HLA-A02 allele having the same antigen-binding domain as HLA-A02:05;
②HLA-A02:07 (or the HLA-A02 allele having the same antigen-binding domain as HLA-A02:07) or any A02 null allele as the sole HLA-A02 allele.
For example, subjects containing both HLA02:01 and HLA02:07 meet this inclusion criterion.
Eastern Cooperative Oncology Group (ECOG) of 0 or 1;
Expected survival time ≥3 months;
Has the ability to collect peripheral blood for the preparation of TCR-T;
Absolute neutrophil count ≥ 1×10^9/L;
Platelet count ≥50×10^9/L, hemoglobin >90g/dL;
Absolute lymphocyte count ≥0.5×10^9/L;
Demonstrate adequate normal organ function:
Alanine aminotransferase ≤ 2.5× ULN (upper limit of normal value);
Aspartate aminotransferase ≤ 2.5× ULN;
Creatinine clearance rate ≥ 60 mL/min;
Serum total bilirubin ≤ 1.5× ULN;
Echocardiography diagnosed that the left ventricular ejection fraction (LVEF) of the subjects was ≥50% and no clinically significant pericardial effusion was observed.
No clinically significant electrocardiogram abnormalities were observed;
In the indoor natural air environment, the basic oxygen saturation exceeds 95%.
Women of childbearing age must have negative pregnancy results in blood human chorionic gonadotropin (HCG) (immunofluorescence method) during the screening period and baseline period, and agree to take effective contraceptive measures for at least one year after infusion; Male patients whose partners are women of childbearing age must agree to use effective barrier contraception for at least one year after infusion and avoid sperm donation. Contraceptive methods must include one highly effective and one additional effective (barrier) contraceptive method, which should be used from the start of screening until at least one year after TCR-T cell infusion or until two consecutive flow cytometry tests show that TCR-T cells are no longer present (whichever occurs later).
Has a specified washout period from prior anti-tumor therapies to peripheral blood collection for TCR-T preparation and before lymphodepleting chemotherapy: 1) anti-angiogenic drugs: 4 weeks; 2) chemotherapy and targeted therapy: 3 weeks; 3) radiotherapy: 2 weeks; 4) endocrine therapy: 1 week. Have recovered from prior therapy-related adverse events to Grade≤1 per CTCAE version 5.0 criteria or met the criteria of normal organ function specified above, except for second-degree peripheral nerve injury, alopecia, leukoderma, hypothyroidism controlled by thyroid hormone replacement therapy, type 1 diabetes controlled by insulin therapy, and other irreversible toxic events that would not be exacerbated by TCR-T infusion as judged by the investigator (e.g., hearing loss).

Who cannot join

Suffering from other malignant tumors (excluding non-melanoma skin cancer that is disease-free for more than 5 years, cervical cancer in situ, bladder cancer in situ and breast cancer in situ that have undergone surgical treatment and show no signs of recurrence);
Has a history of mental disorders that may affect compliance with this plan or prevent the signing of the informed consent form;
Has poorly controlled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >90 mmHg), or has suffered from grade III-IV heart failure or myocardial infarction, cardiac angioplasty or stent implantation, unstable angina pectoris, or other heart diseases with prominent clinical symptoms within one year prior to signing the informed consent form, or exhibits the QTc interval for males greater than 450 ms, and for females greater than 470 ms (the QTc interval is calculated using the Fridericia formula) during screening.
Has known active CNS metastases and/or carcinomatous meningitis except for previously treated and radiographically stable CNS metastases, or CNS metastase without medication requirement and corticosteroid dependence. To demonstrate radiographic stability of brain metastases, a minimum of 2 post-treatment brain imaging assessments are required: (1) The first brain imaging must be acquired after treatment of brain metastases has been completed; (2) The second brain imaging must be obtained during screening and 4 weeks after the previous post-treatment brain imaging.
Any of the following virological test results is positive:
Human immunodeficiency virus antibody (HIV antibody);

Show all 21Show fewer

Patients that are hepatitis B surface antigen (HBsAg) or hepatitis B core antigen (HBcAg) positive may participate provided that the HBV DNA level is normal. Participants that are hepatitis C antibody positive may participate provided that the HBV DNA level is normal. Participants that are hepatitis C antibody positive may receive anti-virus therapy, and take regular DNA copy number tests during this trial.
Treponema pallidum antibody (TP antibody). If necessary, additional tests can be conducted to rule out active syphilis before enrollment.
Has fungal, bacterial, viral or other infections that exist or are suspected to be uncontrollable or require intravenous administration for treatment;
Presents with significant bleeding tendencies, such as active gastrointestinal bleeding, coagulation dysfunction, etc.
Has a history of severe allergies or allergic constitutions;
Has a history of autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) that require systemic immunosuppressive/systemic disease regulatory drugs within the past two years;
Suffered from interstitial lung disease (such as pneumonia, pulmonary fibrosis) during the screening period, or has a clinically significant history of respiratory diseases;
Has a history of organ transplantation;
Has received gene therapy or other cell therapy targeting the same target within 6 months;
Has participated in other clinical trials within 4 weeks prior to the signing of the informed consent form, or the date of signing the informed consent form is still within 5 half-lives of the drug from the last participation in the clinical trial (whichever is longer).
Exhibits poor compliance due to physiological, family, social, geographical or other factors and are unable to cooperate and follow the research protocol and follow-up plan;
Has contraindications to cyclophosphamide, fludarabine, IL-2 or other drugs related to the study treatment;
Has complications that require systemic corticosteroid treatment (≥5 mg/day of dexamethasone or equivalent doses of other corticosteroids) or other immunosuppressive drug treatment within 12 weeks after the start of the study treatment.
Lactating women who are unwilling to stop breastfeeding;
Has any other conditions that researchers consider unsuitable for inclusion in the group.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Shicheng Su, PhD contact

+86 18664737343

magea4_mesenchymal@163.com

Yan Nie, PhD contact

+86 13719237746

magea4_mesenchymal@163.com

China1 site, 1 recruiting

Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, 510120
Shicheng Su, PhD, +86 18664737343, magea4_mesenchymal@163.com
Yan Nie, PhD, +86 13719237746, magea4_mesenchymal@163.com
Recruiting

Other trials in China

About this study

Official title: Exploratory Clinical Study of TCR-T in MAGE-A4-positive Mesenchymal Malignancies

RATIONALE: MAGE-A4 is a cancer-testis antigen widely expressed in various mesenchymal tumors but absent in normal tissues, making it an ideal immunotherapeutic target. Given the limited effectiveness of conventional therapies in advanced mesenchymal tumors, this study seeks to explore a novel treatment approach by engineering autologous T cells with a high-affinity TCR specific for MAGE-A4. PUOPOSE: This exploratory clinical study will assess safety profiles, treatment tolerance, and preliminary antitumor activity in patients with advanced mesenchymal malignancies.

Conditions: Advanced Mesenchymal Malignancies
Being tested: TCR-T cells targeting MAGE-A4
Keywords: Advanced mesenchymal malignancies, MAGE-A4, TCR-T

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TCR-T cells targeting MAGE-A4Biological
Infusion of TCR-T cells targeting MAGE-A4 on Day 1

Study groups in NCT07467122
Study group	Role	What they receive
TCR-T cells	Experimental	Not described Receives: Biological: TCR-T cells targeting MAGE-A4

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of participants with treatment-related Grade ≥3 cytokine release syndrome (CRS) or neurotoxicity assessed according to ASTCT criteria.
Incidence of Grade ≥3 cytokine release syndrome (CRS) or neurotoxicity related to TCR-T cell infusion that cannot be reversed to Grade ≤2 within 7 days after appropriate therapeutic intervention.
Measured: Within 7 days after TCR-T cell infusion.
Number of participants with treatment-related Grade ≥3 non-hematologic adverse events assessed by CTCAE v5.0.
Incidence of treatment-related Grade ≥3 non-hematologic toxicities following TCR-T cell infusion that cannot be reversed to Grade ≤2 within 28 days after therapeutic intervention.
Measured: Within 28 days after TCR-T cell infusion.
Number of participants experiencing adverse events (AE) and serious adverse events (SAE).
Incidence of adverse events and serious adverse events related to TCR-T cell infusion, graded according to CTCAE v5.0.
Measured: Within 96 weeks after TCR-T cell infusion.

Secondary outcomes (11)

Objective Response Rate (ORR) according to RECIST version 1.1.
The proportion of participants achieving complete response (CR) or partial response (PR) based on RECIST 1.1 criteria.
Measured: Within 96 weeks after TCR-T cell infusion.
Disease Control Rate (DCR) according to RECIST version 1.1
The proportion of participants achieving CR, PR, or stable disease (SD).
Measured: From enrollment to 96 weeks after TCR-T infusion.
Time to Response (TTR)
Time from TCR-T cell infusion to the first documented objective response (CR or PR) according to RECIST 1.1.
Measured: Up to 96 weeks after TCR-T infusion.
Duration of Response (DoR)
Time from the first documented objective response to disease progression or death according to RECIST 1.1.
Measured: Up to 96 weeks after TCR-T infusion.
Progression-Free Survival (PFS)
Time from enrollment to disease progression or death from any cause according to RECIST 1.1.
Measured: Up to 96 weeks after TCR-T infusion.
Overall Survival (OS)
Time from enrollment to death from any cause.
Measured: Up to 5 years.
Copy number of TCR gene in peripheral blood
Quantification of the TCR gene copy number in peripheral blood.
Measured: Within 96 weeks after TCR-T infusion.
Number of circulating TCR-T cells in peripheral blood
Enumeration of TCR-T cells in peripheral blood.
Measured: Within 96 weeks after TCR-T infusion.
Peak concentration of circulating TCR-T cells (Cmax)
Maximum observed level of circulating TCR-T cells in peripheral blood after infusion.
Measured: Within 96 weeks after infusion.
Time to peak concentration of TCR-T cells (Tmax)
Time from TCR-T infusion to the peak concentration of circulating TCR-T cells.
Measured: Within 96 weeks after infusion.
Area under the curve of TCR-T cell concentration (AUC0-28)
Area under the concentration-time curve of circulating TCR-T cells from Day 0 to Day 28.
Measured: Within 28 days after infusion.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Mar 202631 Dec 2031

First posted12 Mar 2026
Study start15 Mar 2026 (estimated)
Primary completion31 Dec 2029 (estimated)
Study completion31 Dec 2031 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Mesenchymal MalignanciesStudies of the same condition, open and under way.
More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
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: 15 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07467122
Sponsor's protocol ID: SYSEC【2025】02
Status last verified: Mar 2026
First submitted: 3 Dec 2025
Last updated: 12 Mar 2026
Results posted: No
Data monitoring committee: No
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 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Exploratory Clinical Study of TCR-T in MAGE-A4-positive Mesenchymal Malignancies
ClinicalTrials.gov ID: NCT07467122
Acronym / sponsor ID: SYSEC【2025】02
Conditions: Advanced Mesenchymal Malignancies
Keywords: Advanced mesenchymal malignancies, MAGE-A4, TCR-T
Phase: Phase 1
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 15 participants (estimated)
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
Study start: 15 Mar 2026 (estimated)
Primary completion: 31 Dec 2029 (estimated)
Study completion: 31 Dec 2031 (estimated)
First posted: 12 Mar 2026 (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.

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 cells	Experimental	Biological: TCR-T cells targeting MAGE-A4

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (26 listed)

Voluntarily sign a written informed consent form;
Gender is not limited. Age range: 18 to 75 years old (including the critical value).
Has histopathologically confirmed advanced mesenchymal malignancies, including but not limited to malignant phyllodes tumors of the breast, soft tissue sarcomas, osteosarcomas, etc. Has recurrent tumors, metastatic tumors or locally advanced tumors that have progressed after treatment and cannot be surgically resected, and has failed or cannot tolerate at least one line of standard treatment.
Has at least one measurable lesion (per RECIST1.1);
The H-score of MAGE-A4 expression in the patient's tumor tissue detected by immunohistochemistry reached 30 points or above.

Key exclusion criteria (21 listed)

Suffering from other malignant tumors (excluding non-melanoma skin cancer that is disease-free for more than 5 years, cervical cancer in situ, bladder cancer in situ and breast cancer in situ that have undergone surgical treatment and show no signs of recurrence);
Has a history of mental disorders that may affect compliance with this plan or prevent the signing of the informed consent form;
Has poorly controlled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >90 mmHg), or has suffered from grade III-IV heart failure or myocardial infarction, cardiac angioplasty or stent implantation, unstable angina pectoris, or other heart diseases with prominent clinical symptoms within one year prior to signing the informed consent form, or exhibits the QTc interval for males greater than 450 ms, and for females greater than 470 ms (the QTc interval is calculated using the Fridericia formula) during screening.
Has known active CNS metastases and/or carcinomatous meningitis except for previously treated and radiographically stable CNS metastases, or CNS metastase without medication requirement and corticosteroid dependence. To demonstrate radiographic stability of brain metastases, a minimum of 2 post-treatment brain imaging assessments are required: (1) The first brain imaging must be acquired after treatment of brain metastases has been completed; (2) The second brain imaging must be obtained during screening and 4 weeks after the previous post-treatment brain imaging.
Any of the following virological test results is positive:

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
TCR-T cells targeting MAGE-A4Infusion of TCR-T cells targeting MAGE-A4 on Day 1	Biological	TCR-T cells

Primary outcome

Number of participants with treatment-related Grade ≥3 cytokine release syndrome (CRS) or neurotoxicity assessed according to ASTCT criteria.
Time frame: Within 7 days after TCR-T cell infusion.
Incidence of Grade ≥3 cytokine release syndrome (CRS) or neurotoxicity related to TCR-T cell infusion that cannot be reversed to Grade ≤2 within 7 days after appropriate therapeutic intervention.
Number of participants with treatment-related Grade ≥3 non-hematologic adverse events assessed by CTCAE v5.0.
Time frame: Within 28 days after TCR-T cell infusion.
Incidence of treatment-related Grade ≥3 non-hematologic toxicities following TCR-T cell infusion that cannot be reversed to Grade ≤2 within 28 days after therapeutic intervention.
Number of participants experiencing adverse events (AE) and serious adverse events (SAE).
Time frame: Within 96 weeks after TCR-T cell infusion.
Incidence of adverse events and serious adverse events related to TCR-T cell infusion, graded according to CTCAE v5.0.

11 secondary outcomes

Objective Response Rate (ORR) according to RECIST version 1.1.
Time frame: Within 96 weeks after TCR-T cell infusion.
Disease Control Rate (DCR) according to RECIST version 1.1
Time frame: From enrollment to 96 weeks after TCR-T infusion.
Time to Response (TTR)
Time frame: Up to 96 weeks after TCR-T infusion.
Duration of Response (DoR)
Time frame: Up to 96 weeks after TCR-T infusion.
Progression-Free Survival (PFS)
Time frame: Up to 96 weeks after TCR-T infusion.
Overall Survival (OS)
Time frame: Up to 5 years.
Copy number of TCR gene in peripheral blood
Time frame: Within 96 weeks after TCR-T infusion.
Number of circulating TCR-T cells in peripheral blood
Time frame: Within 96 weeks after TCR-T infusion.
Peak concentration of circulating TCR-T cells (Cmax)
Time frame: Within 96 weeks after infusion.
Time to peak concentration of TCR-T cells (Tmax)
Time frame: Within 96 weeks after infusion.
Area under the curve of TCR-T cell concentration (AUC0-28)
Time frame: Within 28 days after infusion.

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 12 Mar 2026.
Individual participant dataSharing planned: No

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.

Shicheng Su, PhD contact

+86 18664737343

magea4_mesenchymal@163.com

Yan Nie, PhD contact

+86 13719237746

magea4_mesenchymal@163.com

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 TCR-T cells targeting MAGE-A4 in people with Advanced Mesenchymal Malignancies, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 26 inclusion and 21 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 12 Mar 2026. 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 Shicheng Su, PhD (+86 18664737343, magea4_mesenchymal@163.com), 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 Grade ≥3 cytokine release syndrome (CRS) or neurotoxicity assessed according to ASTCT criteria. (time frame: Within 7 days after TCR-T cell infusion.). 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?

On the ClinicalTrials.gov record for NCT07467122.

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 12 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.