To evaluate the safety and tolerability of satri-cel as consolidation therapy after postoperative adjuvant therapy in patients with resected gastric or gastroesophageal junction (G/GEJ) adenocarcinoma
The primary objective of this trial is to evaluate the safety and tolerability of satri-cel as consolidation therapy after postoperative adjuvant therapy in patients with G/GEJ adenocarcinoma. The primary endpoint is the frequency, type, severity and outcome of AE/SAE/AESI, which is the routine assessment indicators for evaluating the safety and tolerability of the investigational product in clinical trials.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
The planned dose of satri-cel in this trial was 2.5 × 108 cells, single infusion. The trial will start with a safety run-in phase, which is defined from the day of infusion to the 28th day after infusion for the first 6 participants. The type, grade, incidence rate, and outcome of adverse events during the safety run-in phase will be summarized and assessed by the investigator and collaborator (CARsgen Therapeutics Co., Ltd). The investigator and collaborator could discuss and assess whether the lower or higher doses should be explored based on the based on the safety and tolerability, cellular metabolic characteristics, and benefit-risk profile. If no dose adjustment is required, satri-cel dose will continue to be 2.5 × 108 cells for the rest of the participants.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Beijing Gaobo Hospital
Beijing, Beijing Municipality, China
Nanjing Gulou Hospital
Nanjing, Jiangsu, China
Incidence, type, and severity of adverse events
ncidence, type, and severity of adverse events, including * Adverse Events (AEs) * Adverse Events of Special Interest (AESIs) * Serious Adverse Events (SAEs)
Time frame: Signed ICF to 15 years after CT041 infusion
Disease-free survival (M12-DFS)
Disease-free survival (M12-DFS) rate at 12 months after surgery
Time frame: 12 months after surgery
Disease-free survival (DFS) after surgery
Disease-free survival (DFS) after surgery
Time frame: Up to approximately 24 months
Distant metastasis-free survival (DMFS) after surgery
Distant metastasis-free survival (DMFS) after surgery
Time frame: Up to approximately 24 months
Overall Survival (OS)
Overall Survival (OS)
Time frame: Up to approximately 24 months
To evaluate the cellular metabolism kinetics of satri-celrea under the curve (AUC) and sustained cell survival (Tlast) after satri-cel infusion
CAR copy number, time to peak amplification (Tmax), peak amplification (Cmax), area under the curve (AUC) and sustained cell survival (Tlast) after satri-cel infusion
Time frame: up to 18 months
To evaluate the immunogenicity of satri-cel
Anti-drug antibody (ADA) positive rate after infusion of satri-cel cells
Time frame: up to 18 months
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