Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 11:02 AM
Study NCT ID:
NCT07399769
Status:
RECRUITING
Last Update Posted:
2026-02-10
First Post:
2026-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of MSLN CAR-T in Advanced Malignant Tumors
Sponsor:
Shenzhen University General Hospital
Organization:
Study Overview
Official Title:
Efficacy and Safety of MSLN CAR-T in Advanced Malignant Tumors
Status:
RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
Detailed Description:
This is a prospective, interventional Phase I/II clinical study designed to evaluate the safety and efficacy of MSLN-targeted CAR-T cell therapy in patients with advanced malignant tumors. A total of 20 patients aged 18-75 years with unresectable, locally advanced, recurrent, or metastatic solid malignancies will be enrolled. All patients must have histopathologically confirmed disease and positive MSLN expression in tumor tissue.
MSLN CAR-T cells will be administered as a single intravenous infusion at a total dose of 0.5-2 × 10\^6 CAR-T cells/kg. Eligible subjects (N=20) will be assigned by the investigator to receive MSLN CAR-T cell infusion.
Endpoints:
* Primary Endpoint:
o Incidence and severity of treatment-emergent adverse events (TEAEs) within 30 days after MSLN CAR-T cell infusion.
* Secondary Endpoints:
* Objective response rate (ORR = CR + PR) assessed within 8 weeks after infusion;
* Overall survival (OS) and progression-free survival (PFS) at 6 months;
* In vivo expansion and persistence kinetics of infused CAR-T cells.
This is a prospective, interventional Phase I/II clinical study designed to evaluate the safety and efficacy of MSLN-targeted CAR-T cell therapy in patients with advanced malignant tumors. A total of 20 patients aged 18-75 years with unresectable, locally advanced, recurrent, or metastatic solid malignancies will be enrolled. All patients must have histopathologically confirmed disease and positive MSLN expression in tumor tissue.
MSLN CAR-T cells will be administered as a single intravenous infusion at a total dose of 0.5-2 × 10\^6 CAR-T cells/kg. Eligible subjects (N=20) will be assigned by the investigator to receive MSLN CAR-T cell infusion.
Endpoints:
* Primary Endpoint:
o Incidence and severity of treatment-emergent adverse events (TEAEs) within 30 days after MSLN CAR-T cell infusion.
* Secondary Endpoints:
* Objective response rate (ORR = CR + PR) assessed within 8 weeks after infusion;
* Overall survival (OS) and progression-free survival (PFS) at 6 months;
* In vivo expansion and persistence kinetics of infused CAR-T cells.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: