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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.

NCT07420010 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-02-19

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Weijia Fang, MD

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-15
Primary Completion
2028-12-31
Completion
2028-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07420010 on ClinicalTrials.gov