NCT07420010

An Open-label, Single-arm Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of KT032 Cell Injection in Patients With Mesothelin-positive Advanced Solid Tumors.

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Weijia Fang, MD · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

An Open-label, Single-arm Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of KT032 Cell Injection in Patients With Mesothelin-positive Advanced Solid Tumors.

Detailed description

This is a single-arm, single-center, open-label, dose-escalation and expansion study to investigate the safety and tolerability, pharmacokinetics, and preliminary efficacy of the investigational product administered via intraperitoneal injection in adult patients with advanced solid tumors. Dose-Escalation Phase： After providing informed consent, subjects will be screened for eligibility based on inclusion/exclusion criteria. Eligible subjects will receive KT032 treatment. Dose escalation will follow the "3+3" principle across three dose cohorts: 1.0×10⁶, 2.0×10⁶, and 3.0×10⁶ CAR-T cells/kg (for the highest dose cohort, dosing will be calculated based on 70 kg for subjects weighing \>70 kg). Given the special nature of the cellular product, a ±20% variance in the actual administered dose is permitted for each cohort. This phase plans to enroll 12-18 subjects with single-dose administration. Dose-Expansion Phase： Based on data from the dose-escalation phase, one optimal dose cohort will be selected to expand with 6 additional subjects. The specific expansion study plan and sample size will be determined according to preliminary safety, PK, and efficacy data obtained during the dose-escalation phase.

Conditions

• Ovarian Cancer
• Mesothelioma
• Colon Cancer

Interventions

Type	Name	Description
BIOLOGICAL	KT032(anti-MSLN chimeric antigen receptor autologous T cell injection)	Lymphodepletion conditioning is required prior to administration of anti-MSLN chimeric antigen receptor autologous T cell injection (KT032). KT032 is administered via intraperitoneal injection (10-30 ml cell injection solution by intraperitoneal bolus), 1 bag per dose, for a total of 1 dose. The investigational product dose will be determined based on the subject's body weight and the number of viable CAR-positive T cells. Dosing according to the pre-specified dose levels: 1.0×10⁶ CAR-T cells/kg, 2.0×10⁶ CAR-T cells/kg, and 3.0×10⁶ CAR-T cells/kg (for the highest dose cohort, if body weight exceeds 70 kg, dose calculation will be based on 70 kg). Given the special nature of cell products, an actual dosing variation of ±20% is permitted for each dose cohort.

Timeline

• Start date: 2026-03-15
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2026-02-19
• Last updated: 2026-02-19