A single-center, single-arm, dose-escalation exploratory clinical trial of the safety, efficacy, and pharmacokinetics of XKDCT225 cell injection in Claudin18.2-positive advanced solid tumors
This study is a prospective, single-arm, open-label, single-dose dose-finding study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy characteristics of XKDCT225 cell injection preparation in subjects with Claudin18.2-positive advanced solid tumors. The study will enroll subjects with pathologically confirmed advanced solid tumors, positive Claudin18.2 expression, who have previously received standard treatment, failed treatment or cannot tolerate it. Imaging examinations show evaluable tumor lesions. This study adopts a single-arm, single-center, dose-escalation design, and uses "accelerated titration" and "3+3" trial designs for dose escalation . It is expected to include 9-18 patients to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of XKDCT225 cell injection . Main purpose: the safety and tolerability of XKDCT225 cell injection in patients with Claudin18.2-positive advanced solid malignancies. Secondary Purpose: the pharmacokinetic and pharmacodynamic characteristics of XKDCT225 cell injection in patients with Claudin18.2-positive advanced solid malignancies; To preliminarily evaluate the efficacy of XKDCT225 cell injection in patients with Claudin18.2-positive advanced solid malignancies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Autologous targeted claudin18.2 chimeric antigen receptor T cell injection
AnYang Tumor Hospital
Anyang, Henan, China
RECRUITINGDose limiting toxicity (DLT)
Dose limiting toxicity (DLT) in the dose escalation phase
Time frame: 28 days of single infusion
Maximum tolerated dose (MTD)
Maximum tolerated dose (MTD) in the dose escalation phase
Time frame: 28 days of single infusion
The incidence and severity of adverse events (AEs) (%)
The incidence and severity of AEs
Time frame: 1 year
Pharmacokinetics (the number of CAR copies (copies/μg gDNA) in peripheral blood)
The number of CAR copies (copies/μg gDNA) were detected by qPCR method to determine the peak time (day) of XKDCT225, sustained survival period (day).
Time frame: 1 year
Peripheral blood cytokines
Including IL-6 concentration (pg/ml) , etc.
Time frame: 1 year
XKDCT293 immunogenicity assay
employing a validated electrochemiluminescence (ECL) assay on the MESO QuickPlex SQ 120 system from Meso Scale Discovery (MSD). This assay detects XKDCT293 antibody titer (ng/ml) by measuring the emitted light from the SULFO-TAG label.
Time frame: 1 year
Objective response rate (ORR) (%)
According to RECIST 1.1 criteria, the percentage of the analyzed population with the best efficacy evaluation reaching CR and PR.
Time frame: 1 year
Time to response (TTR) (month)
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According to RECIST 1.1 criteria, the time interval from the date of initial infusion of the study drug to the date of initial assessment of partial remission or better outcome in patients with the best efficacy evaluation as partial remission or better outcome.
Time frame: 1 year
Duration of Overall Response (DOR) (month)
According to RECIST 1.1 criteria, in patients with the best efficacy evaluation of CR or PR, the time (month) from the first evaluation of the tumor as CR or PR to the first evaluation as PD or death from any cause (whichever occurs first).
Time frame: 1 year
Progression-free survival (PFS) (month)
From the first infusion of the study drug to the date of the first recorded tumor progression (whether treated or not) or the date of death for any reason, whichever occurs first.
Time frame: 1 year
Overall survival (OS) (month)
The time between the patient's first infusion of the study drug and the patient's death due to various reasons.
Time frame: 1 year