Actively Recruiting
Exploratory Clinical Study of TCR-T for MAGE-A4-positive Mesenchymal Malignancies
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2026-03-12
15
Participants Needed
1
Research Sites
302 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Exploratory Clinical Study of TCR-T for MAGE-A4-positive Mesenchymal Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old
- Voluntarily sign written informed consent
- Histopathologically confirmed advanced mesenchymal malignancies with recurrent, metastatic, or locally advanced tumors not resectable by surgery
- Tumors progressed after or intolerant to at least one line of standard treatment
- At least one measurable lesion as per RECIST1.1
- MAGE-A4 expression H-score of 30 or above in tumor tissue
- HLA-A*02 positive with specific allele exceptions detailed in the protocol
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Expected survival time of at least 3 months
- Ability to collect peripheral blood for TCR-T preparation
- Absolute neutrophil count ≥ 1 x 10^9/L
- Platelet count ≥ 50 x 10^9/L and hemoglobin > 90 g/dL
- Absolute lymphocyte count ≥ 0.5 x 10^9/L
- Adequate organ function including liver enzymes, creatinine clearance, bilirubin, heart function, ECG, and oxygen saturation
- Women of childbearing potential must have negative pregnancy test and agree to contraception for at least one year post-infusion; male patients must agree to contraception
- Specified washout periods from prior anti-tumor therapies and recovery from related adverse events per protocol
You will not qualify if you...
- Presence of other malignant tumors except certain treated and disease-free skin or in situ cancers
- History of mental disorders affecting compliance or consent ability
- Poorly controlled hypertension or significant heart disease within one year before consent
- Known active central nervous system metastases or carcinomatous meningitis except stable treated brain metastases
- Positive tests for HIV, active hepatitis B or C without controlled viral levels, or active syphilis
- Uncontrollable infections requiring intravenous treatment
- Significant bleeding disorders
- History of severe allergies or allergic conditions
- Autoimmune diseases requiring systemic immunosuppressive treatment in past two years
- Interstitial lung disease or significant respiratory disease history
- History of organ transplantation
- Prior gene or cell therapy targeting the same antigen within six months
- Participation in other clinical trials within four weeks or within five drug half-lives
- Poor compliance or inability to follow protocol and follow-up
- Contraindications to study drugs including cyclophosphamide, fludarabine, IL-2
- Need for systemic corticosteroids or immunosuppressive drugs within 12 weeks after study start
- Lactating women unwilling to stop breastfeeding
- Any other condition deemed unsuitable by the researchers
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China, 510120
Actively Recruiting
Research Team
S
Shicheng Su, PhD
CONTACT
Y
Yan Nie, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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