To evaluate the safety and tolerability of CT0494BCP following infusion in participants with advanced gastric/esophagogastric junction adenocarcinoma (G/GEJA) To evaluate preliminary efficacy of CT0494BCP To evaluate the cellular metabolism kinetics of CT0494BCP The investigational drug in this study is CT0494BCP cells, including CT0494 cells and CT7095 cells. Dose escalation will be performed according to the Bayesian optimal interval (BOIN) design principle (refer to the dose escalation principle in Section 4.1 Study Design Description and the flow chart of BOIN design in Figure 2 for details) and dose expansion. In the dose escalation phase, CT0494 cells were tentatively assigned to 3 escalating doses of 3.0 × 108, 4.5 × 108 and 6.0 × 108, respectively, and CT7095 cells were tentatively assigned to 2 escalating doses of 1.5 × 108 and 3.0 × 108, respectively. If the exploratory dose is not identified as a possible recommended dose (RD), a possible RD may be explored by escalating to a higher dose or tapering to a lower dose at the discretion of the investigator and sponsor in consultation. Dose groups, number of subjects per dose group, and other escalation or de-escalation decisions may be adjusted during the study based on available data.
Total duration of study intervention per study participant: The study intervention for this study consists of: CLEAR PRECONDITION and CT0494BCP INFUSION. * Cleaning pretreatment Cleaning pretreatment was performed 5 days before cell infusion (D-5 \~ D-3). * Cell infusion CT0494BCP cells were infused on the day of cell infusion (D0) (CT7095 cells were recommended on D0 and CT0494 cells were recommended on D2). Total duration of each study participant's participation in the study: The total duration of each study participant's participation in the study is from the screening period until completion or withdrawal from the study, whichever occurs first. * Target Pre-Screening Period Study participants will provide tumor tissue samples for CLDN18.2 target testing at the central laboratory after signing the prescreening informed consent form. For study participants who fail pre-screening and do not sign the main informed consent form, only study participant demographic information, time of signing the pre-screening informed consent form, and CLDN18.2 target test results will be recorded in the electronic case report form (eCRF). * Screening period Each study participant will sign the informed consent form before any study-related procedures are performed. Screening examinations were to be completed within approximately 2 weeks prior to CLL. * clearing stranguria Pre-treatment of study participants (D-5 \~ D-3) with lymphatic clearing is expected to last for 3 days. * Infusion and Post-infusion Observation Period and Follow-up Period Study participants enter a post-infusion observation period and follow-up period starting on the day of CT0494BCP infusion (D0), which is expected to last approximately 52 weeks. Study participants were closely observed for 4 weeks after infusion and followed every 6 weeks until completion of the 52-week follow-up visit or early withdrawal from treatment. * Long-term follow-up Study participants who prematurely withdraw or complete the CT0494BCP infusion and post-infusion observation period and follow-up period are required to enter the long-term follow-up period or enter a separate long-term follow-up study as required by the protocol until 15 years post-infusion.
Study Type
OBSERVATIONAL
Enrollment
50
CT0494 Cell Dose 3.0 × 108 CT7095 Cell Dose 1.5 × 108
CT0494 Cell Dose 4.5 × 108 CT7095 Cell Dose 1.5 × 108
CT0494 Cell Dose 6.0×108 CT7095 Cell Dose 1.5×108
CT0494 Cell Dose 3.0 × 108 CT7095 Cell Dose 3.0 × 108
CT0494 Cell Dose 4.5 × 108 CT7095 Cell Dose 3.0 × 108
CT0494 Cell Dose 6.0 × 108 CT7095 Cell Dose 3.0 × 108
BeijingGoBroadH
Beijing, Beijing Municipality, China
To evaluate the safety and tolerability of CT0494BCP following infusion in participants with advanced gastric/esophagogastric junction adenocarcinoma (G/GEJA)
treatment-related adverse events (TRAE)
Time frame: 12 months after infusion
To evaluate the safety and tolerability of CT0494BCP following infusion in participants with advanced gastric/esophagogastric junction adenocarcinoma (G/GEJA)
• Frequency, type, and severity of adverse events, including treatment-emergent adverse events (TEAE)
Time frame: 12 months after infusion
To evaluate the safety and tolerability of CT0494BCP following infusion in participants with advanced gastric/esophagogastric junction adenocarcinoma (G/GEJA)
serious adverse events (SAE), and adverse events of special interest (AESI)
Time frame: To evaluate the safety and tolerability of CT0494BCP following infusion in participants with advanced gastric/esophagogastric junction adenocarcinoma (G/GEJA)
To evaluate the safety and tolerability of CT0494BCP following infusion in participants with advanced gastric/esophagogastric junction adenocarcinoma (G/GEJA)
Dose limiting toxicity (DLT)
Time frame: 28 days after infusion
To evaluate the safety and tolerability of CT0494BCP following infusion in participants with advanced gastric/esophagogastric junction adenocarcinoma (G/GEJA)
recommended dose (RD)
Time frame: 28 days after infusion
To evaluate preliminary efficacy of CT0494BCP
ORR
Time frame: 24 months
To evaluate preliminary efficacy of CT0494BCP
DOR
Time frame: 24 months
To evaluate preliminary efficacy of CT0494BCP
DCR
Time frame: 24 months
To evaluate preliminary efficacy of CT0494BCP
DDC
Time frame: 24 months
To evaluate preliminary efficacy of CT0494BCP
PFS
Time frame: 24 months
To evaluate preliminary efficacy of CT0494BCP
OS
Time frame: 24 months
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