Actively Recruiting
Efficacy and Safety of MSLN CAR-T in Advanced Malignant Tumors
Led by Shenzhen University General Hospital · Updated on 2026-02-10
20
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
1. Study Title: Efficacy and safety of MSLN CAR-T in advanced malignant tumors 2. Study Objectives: Primary: To evaluate the safety and tolerability of MSLN-targeted CAR-T cell therapy in patients with stage III/IV advanced malignant tumors. Secondary: To preliminarily evaluate the efficacy of MSLN-targeted CAR-T cell therapy in this patient population. Exploratory: To assess in vivo expansion and persistence of infused MSLN-targeted CAR-T cells and explore correlations with clinical outcomes. 3. Participant Intervention: Participants will receive lymphodepleting chemotherapy (FC regimen: Fludarabine + Cyclophosphamide) on Days -5, -4, and -3 relative to the planned MSLN CAR-T cell infusion. The CAR-T cell infusion will be administered 72 hours after the completion of the FC chemotherapy.
CONDITIONS
Official Title
Efficacy and Safety of MSLN CAR-T in Advanced Malignant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years, any gender
- Voluntary participation with signed informed consent
- Histopathologically confirmed unresectable, locally advanced, recurrent, or metastatic solid malignant tumor at stage III or IV
- Measurable and evaluable lesions according to RECIST v1.1
- Positive MSLN expression in tumor tissue confirmed by immunohistochemistry
- Received standard first-line therapy with disease progression or intolerance
- Not suitable for curative treatments like chemoradiotherapy, surgery, or immune checkpoint inhibitors, or refuses surgery
- No antibody-based therapy within 2 weeks before cell therapy
- ECOG performance status between 0 and 2
- No contraindications to peripheral blood leukapheresis
- Estimated life expectancy of at least 3 months
You will not qualify if you...
- Allergy to any component of the cell product
- Blood count abnormalities: WBC ≤1 x 10^9/L, ANC ≤0.5 x 10^9/L, ALC ≤0.5 x 10^9/L, or platelets ≤25 x 10^9/L
- Laboratory abnormalities: total bilirubin ≥1.5 mg/dL; ALT or AST >2.5 times upper limit of normal; creatinine ≥2.0 mg/dL
- NYHA class III or IV heart failure or left ventricular ejection fraction below 50%
- Oxygen saturation below 92% on room air
- Recent significant cardiac events within 12 months
- Grade 3 hypertension poorly controlled by medication
- History of severe brain injury, epilepsy, or cerebral vascular disease
- Autoimmune disease, immunodeficiency, or need for immunosuppressive therapy
- Uncontrolled active infection
- Prior treatment with any CAR-T or genetically modified T-cell therapy
- Live vaccine within 4 weeks prior to enrollment
- Positive tests for HIV, HBV, HCV, or TPPA/RPR; or HBV carrier status
- History of alcohol abuse, illicit drug use, or psychiatric disorders
- Participation in another clinical study within 3 months
- Female subjects who are pregnant, breastfeeding, planning pregnancy, or unable/unwilling to use effective contraception
- Any condition making the subject unsuitable for participation as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shenzhen University General Hospital
Shenzhen, Other (Non U.s.), China, 518055
Actively Recruiting
Research Team
G
Guocheng Zhong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
1
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