Safety and Efficacy of CT0494BCP in Participants With Advanced Gastric/Esophagogastric Junction A… (NCT07538856) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Safety and Efficacy of CT0494BCP in Participants With Advanced Gastric/Esophagogastric Junction Adenocarcinoma
China50 participantsStarted 2026-04
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Exclusion criteria
✕. 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);
✕. Clinically significant abnormal thyroid function as judged by the investigator (serum thyroid hormone determination includes at least FT3, FT4 and serum thyroid stimulating hormone TSH), but patients with hypothyroidism whose disease is under stable control as assessed by the investigator can enter the trial;
✕. Toxic reactions caused by previous treatment have not recovered to CTCAE v6.0 ≤ Grade 1, except for alopecia and other tolerable events as judged by the investigator or laboratory abnormalities allowed in this trial;
✕. Received anti-tumor treatment for the disease under study within 2 weeks prior to CLL, including but not limited to surgery, systemic chemotherapy (or within 5 half-lives of the drug, whichever is shorter), radiotherapy, intervention, etc., or received anti-PD-(L) 1 monoclonal antibody therapy or CLDN18.2 targeted therapy or other non-marketed clinical trial drugs within 4 weeks prior to CLL (or within 5 half-lives of the drug, whichever is shorter);
What they're measuring
1
To evaluate the safety and tolerability of CT0494BCP following infusion in participants with advanced gastric/esophagogastric junction adenocarcinoma (G/GEJA)
Timeframe: 12 months after infusion
2
To evaluate the safety and tolerability of CT0494BCP following infusion in participants with advanced gastric/esophagogastric junction adenocarcinoma (G/GEJA)
Timeframe: 12 months after infusion
3
To evaluate the safety and tolerability of CT0494BCP following infusion in participants with advanced gastric/esophagogastric junction adenocarcinoma (G/GEJA)
Timeframe: To evaluate the safety and tolerability of CT0494BCP following infusion in participants with advanced gastric/esophagogastric junction adenocarcinoma (G/GEJA)
4
To evaluate the safety and tolerability of CT0494BCP following infusion in participants with advanced gastric/esophagogastric junction adenocarcinoma (G/GEJA)
Timeframe: 28 days after infusion
5
To evaluate the safety and tolerability of CT0494BCP following infusion in participants with advanced gastric/esophagogastric junction adenocarcinoma (G/GEJA)
✕. Ongoing use of glucocorticoids within 7 days prior to CLL. Recent or current use of inhaled or topical dermal glucocorticoids and physiologic replacement therapy doses of glucocorticoids were not excluded;