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

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

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorShenzhen University General Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

CAR-T

Treatment groups

20 Participants

are divided into 1 treatment group

Sponsors and collaborators

Shenzhen University General Hospital

Lead sponsor

Source ClinicalTrials.gov