About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Pregnant or lactating females;
HIV, Treponema pallidum, HCV serology positive (HCV antibody positive but HCV-RNA negative can be included), Epstein-Barr virus (EBV) DNA (plasma or whole blood) positive, cytomegalovirus (CMV) DNA positive;
Any uncontrolled active infection, including but not limited to active tuberculosis, HBV infection (including HBsAg positive, or HBcAb positive with HBV DNA above the lower limit of the laboratory test in our center), and other bacterial, viral or fungal infections requiring drug treatment. Participants who use drugs to prevent infection and can continue the trial as judged by the investigator;
Known HER2-positive (defined as IHC3 +, or IHC2 + with amplification by FISH);
Trial population
Gastric/Esophagogastric Junction Adenocarcinoma
Trial design
Cohort
Prospective
Treatments tested in this trial
Initial Dose (Dose Group 1)
DrugCT0494 Cell Dose 3.0 × 108 CT7095 Cell Dose 1.5 × 108
Dose Group 2
DrugCT0494 Cell Dose 4.5 × 108 CT7095 Cell Dose 1.5 × 108
Dose Group 3
DrugCT0494 Cell Dose 6.0×108 CT7095 Cell Dose 1.5×108
Dose Group 4
DrugCT0494 Cell Dose 3.0 × 108 CT7095 Cell Dose 3.0 × 108
Dose Group 5
DrugCT0494 Cell Dose 4.5 × 108 CT7095 Cell Dose 3.0 × 108
Dose Group 6
DrugCT0494 Cell Dose 6.0 × 108 CT7095 Cell Dose 3.0 × 108
Treatment groups
6
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
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)
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)
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)
To evaluate the safety and tolerability of CT0494BCP following infusion in participants with advanced gastric/esophagogastric junction adenocarcinoma (G/GEJA)
Dose limiting toxicity (DLT)
Secondary outcomes
To evaluate preliminary efficacy of CT0494BCP
ORR
To evaluate preliminary efficacy of CT0494BCP
DOR
To evaluate preliminary efficacy of CT0494BCP
DCR
To evaluate preliminary efficacy of CT0494BCP
DDC
Sponsors and contacts
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