To evaluate the efficacy of CT041 in sequential treatment after first-line treatment of advanced gastric/esophagogastric junction adenocarcinoma
Voluntarily participate in this trial; Fully understand and be informed of this trial and sign the informed consent form; Willing to follow and able to complete all trial procedures;
Age 18-75 years (inclusive), male or female;
Pathologically confirmed unresectable locally advanced or metastatic advanced gastric/esophagogastric junction (G/GEJ) adenocarcinoma;
Immunohistochemical (IHC) staining of tumor tissue sample is CLDN18.2 positive, defined as staining intensity ≥ 2 + in at least 40% of tumor cells;
Presence of a known tumor tissue with high HER2 expression;
Presence of gastrointestinal bleeding/perforation/obstruction or significant risk with these, including but not limited to anastomotic recurrence involving the full thickness of gastric wall, deep large ulcer, unstable/active ulcer, history of gastrointestinal bleeding/perforation/obstruction within 3 months (excluding those with surgical resection of the lesion leading to such event);
Participants who have previously received any anti-tumor therapy other than the first-line treatment regimen for G/GEJ adenocarcinoma allowed in this trial (see Item 5 of the inclusion criteria), including any other systemic anti-tumor drugs, any radiotherapy or interventional therapy, etc.;
Systemic anti-tumor treatment for G/GEJ adenocarcinoma within 21 days (or within 5 half-lives of the drug, whichever is shorter) prior to apheresis;
Participants with unresectable locally advanced or metastatic gastric/esophagogastric junction adenocarcinoma who have not progressed after 12 weeks of first-line therapy.
Case-only
Prospective
CT041 autologous CAR T-cell injection
DrugThe planned dose of CT041 is 2.5×108 cells. The participants are recommended to receive only a single infusion or multiple infusions (up to 3 infusions) according to the safety and efficacy data of the participants per the investigator. The dose and method of re-infusion are the same as the first infusion. Lymphodepletion pretreatment should be given before re-infusion, and the requirements before lymphodepletion pretreatment and cell infusion should also be met before re-lymphodepletion pretreatment or re-infusion.
To evaluate the efficacy of CT041 in sequential treatment after first-line treatment of advanced gastric/esophagogastric junction adenocarcinoma
Progression-free survival (PFS)
peak CAR copy number (Cmax)
peak CAR copy number (Cmax)
Event-free survival (EFS)
Event-free survival (EFS)
Overall survival (OS)
Overall survival (OS)
Incidence, type, and severity of adverse events
Incidence, type and severity of adverse events, including: Adverse events (AEs); Adverse events of special interest (AESIs); Serious Adverse Events (SAEs), etc.
Objective Response Rate（ORR）
Objective Response Rate（ORR）
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