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.

Sponsor
Weijia Fang, MD
Study ID
NCT07420010
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • KT032(anti-MSLN chimeric antigen receptor autologous T cell injection) — BIOLOGICAL
    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.

Study Details

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.

Key Dates

First listed
Feb 19, 2026
Start date
Mar 15, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: KT032：1.0×10⁶ CAR-T cells/kg
  • Experimental: KT032：2.0×10⁶ CAR-T cells/kg
  • Experimental: KT032：3.0×10⁶ CAR-T cells/kg

Primary Outcome Measure

Dose-Limiting Toxicity（DLT） [ Time Frame: 28 days ]

Central Contacts

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