Efficacy and Safety of MSLN CAR-T in Advanced Malignant Tumors

NCT07399769 | Recruiting Phase 1

• 1 other identifier: 112
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

• 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

Advanced Solid Malignant Tumors (With Positive Expression of MSLN in Tumor Tissue)

Outcome Measures

Primary Outcomes (1)

• TRAEs

  Adverse events during treatment

  From date of initial treatment to the 30 days after treatment

Secondary Outcomes (1)

• Disease-related clinical responses

  From date of enrollment until the date of clinical responses,up to 2 years

Study Arms (1)

CART group

EXPERIMENTAL

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.

Combination Product: CAR-T

Interventions

CAR-T COMBINATION_PRODUCT

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.

CART group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-75 years (≥18 and ≤75 years), either sex;
• The subject voluntarily participates in the study and provides written informed consent signed by the subject or his/her legally authorized representative;
• Histopathologically confirmed unresectable, locally advanced, recurrent, or metastatic solid malignant tumor; according to the AJCC TNM staging system (8th edition, 2017), subjects diagnosed with stage III or stage IV solid malignant tumors;
• Presence of measurable and evaluable lesions according to RECIST v1.1;
• Positive MSLN expression in tumor tissue confirmed by immunohistochemistry (IHC);
• The subject must have received standard first-line therapy and has experienced disease progression or is intolerant to such therapy;
• The subject is not suitable for curative treatment modalities such as definitive chemoradiotherapy and/or surgery/immune checkpoint inhibitors, or refuses surgical resection;
• No antibody-based therapy administered within 2 weeks prior to cell therapy;
• ECOG performance status 0-2;
• No contraindications to peripheral blood leukapheresis;
• Estimated life expectancy ≥ 3 months.

You may not qualify if:

• History of allergy to any component of the cell product;
• Any of the following hematologic abnormalities on complete blood count (CBC): WBC ≤ 1 × 10\^9/L, absolute neutrophil count (ANC) ≤ 0.5 × 10\^9/L, absolute lymphocyte count (ALC) ≤ 0.5 × 10\^9/L, or platelets (PLT) ≤ 25 × 10\^9/L;
• Any of the following laboratory abnormalities, including but not limited to: serum total bilirubin ≥ 1.5 mg/dL; serum ALT or AST \> 2.5 × ULN; serum creatinine ≥ 2.0 mg/dL;
• NYHA class III or IV heart failure per the New York Heart Association functional classification, or left ventricular ejection fraction (LVEF) \< 50% on echocardiography;
• Abnormal pulmonary function with oxygen saturation (SpO₂) \< 92% on room air;
• History of myocardial infarction, coronary angioplasty or stenting, unstable angina, or other clinically significant severe cardiac disease within 12 months prior to enrollment;
• Grade 3 hypertension with poor blood pressure control despite medical treatment;
• History of traumatic brain injury, disturbance of consciousness, epilepsy, or severe cerebral ischemic or hemorrhagic disease;
• Presence of autoimmune disease, immunodeficiency, or other conditions requiring immunosuppressive therapy;
• Presence of uncontrolled active infection;
• Prior treatment with any CAR-T cell product or other genetically modified T-cell therapy;
• Receipt of a live vaccine within 4 weeks prior to enrollment;
• Positive test results for HIV, HBV, HCV, and TPPA/RPR, and/or HBV carriers;
• History of alcohol abuse, illicit drug use, or psychiatric disorders;
• Participation in any other clinical study within 3 months prior to enrollment;

Sponsors & Collaborators

• Shenzhen University General Hospital: lead

Study Sites (1)

Shenzhen University General Hospital

Shenzhen, Other (Non U.s.), 518055, China

RECRUITING

Study Officials

• Li Yu

  Shenzhen University General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guocheng Zhong

CONTACT

0755-21839999; m18716354367@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 10, 2026
• Study Start: January 1, 2024
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 30, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)