Observational Safety Trial of CT0494BCP in Advanced Gastric/Esophagogastric Junction Adenocarcinoma
Summary
A new observational safety trial (NCT07538856) evaluating CT0494BCP cell therapy in participants with advanced gastric/esophagogastric junction adenocarcinoma has been registered on ClinicalTrials.gov. The study uses Bayesian optimal interval (BOIN) design for dose escalation across six dose groups. CT0494 cells are assigned to three escalating doses (3.0×10⁸, 4.5×10⁸, 6.0×10⁸), and CT7095 cells to two escalating doses (1.5×10⁸, 3.0×10⁸). The trial will assess safety, tolerability, preliminary efficacy, and cellular metabolism kinetics.
What changed
A new clinical trial registration for an observational study of CT0494BCP cell therapy in gastric/esophagogastric junction adenocarcinoma has been added to ClinicalTrials.gov. The trial employs a Bayesian optimal interval (BOIN) design for dose escalation and expansion phases.
Affected parties include clinical investigators, trial sponsors, and healthcare providers involved in gastric cancer cell therapy research. Pharmaceutical companies conducting similar cell therapy trials should note the BOIN design methodology and dose escalation parameters for comparator purposes.
Archived snapshot
Apr 21, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Safety and Efficacy of CT0494BCP in Participants With Advanced Gastric/Esophagogastric Junction Adenocarcinoma
Observational NCT07538856 Kind: OBSERVATIONAL Apr 20, 2026
Abstract
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.
Conditions: Gastric, Gastric / Gastroesophageal Junction Adenocarcinoma
Interventions: Initial Dose (Dose Group 1), Dose Group 2, Dose Group 3, Dose Group 4, Dose Group 5, Dose Group 6
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