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.
Aged 18 to 75 years (inclusive), any gender;
Histopathologically confirmed diagnosis of advanced solid tumors (including but not limited to ovarian cancer, mesothelioma, colon cancer, etc.), with peritoneal or intraperitoneal metastasis as the primary disease manifestation;
Progression or intolerance to prior systemic standard-of-care treatment according to guidelines (systemic therapy includes but is not limited to systemic chemotherapy, molecular targeted therapy, etc.), and unsuitable for surgery or local treatment (including ablation therapy, interventional therapy, and radiotherapy); specifically: Ovarian cancer: Recurrence during or within 6 months after second-line or later platinum-based chemotherapy; Mesothelioma: Failure of, intolerance to, or ineligibility for at least first-line therapy; Colon cancer: Failure of, intolerance to, or ineligibility for at least third-line therapy;
Ovarian cancer: Progression, intolerance, or ineligibility after second-line standard therapy including carboplatin ± paclitaxel/albumin-bound paclitaxel/docetaxel/pegylated liposomal doxorubicin;
Other malignancies within 5 years prior to screening, except adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, or ductal carcinoma in situ of the breast after radical surgery;
Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive with peripheral blood hepatitis B virus (HBV) DNA titer above the lower limit of detection of the quantitative assay at the study site; Hepatitis C virus (HCV) antibody positive with peripheral blood HCV RNA above the lower limit of detection of the quantitative assay at the study site; Human immunodeficiency virus (HIV) antibody positive; Positive syphilis test;
Patients with central nervous system metastases and/or other unstable central nervous system diseases (hemorrhage, active infarction, infection, etc.);
Receipt of live attenuated vaccine within 4 weeks prior to cell injection;
Sequential
KT032(anti-MSLN chimeric antigen receptor autologous T cell injection)
Biological/VaccineLymphodepletion 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.
Dose-Limiting Toxicity（DLT）
Safety
Maximal Tolerable Dose（MTD）
tolerability evaluation
Adverse Event（AE）
Incidence rate
Serious Adverse Event（SAE）
Incidence rate
PK
CAR-T cells in peripheral blood were analyzed by flow cytometry, and CAR-T copy numbers in peripheral blood were quantified by quantitative PCR (qPCR); patients were followed until CAR-T cells and CAR-T copy numbers in peripheral blood were below the lower limit of quantification (LLOQ) in two consecutive assessments.
Antitumor efficacy-Objective response rate (ORR)
Proportion of patients with Best Overall Response(BOR) of PR or CR
Disease Control Rate (DCR)
Proportion of patients with BOR of PR, CR, or SD
Duration of Response (DOR)
Time interval from first documented CR or PR to first documented PD or death from any cause;
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Weijia Fang, MD
Lead sponsor
Zhejiang University
Sponsor institution
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