Postoperative Adjuvant Therapy for CT041 Gastric or Gastroesophageal Junction (G/GEJ) Adenocarcinoma Patients

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

March 10, 2025

Primary Completion Date

June 30, 2027

Study Completion Date

June 30, 2030

Conditions
Gastroesophageal Junction AdenocarcinomaGastric Adenocarcinoma
Interventions
DRUG

Drug: CT041 autologous CAR T-cell injection

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.

Trial Locations (3)

100142

Beijing Cancer Hospital, Beijing

Beijing Gaobo Hospital, Beijing

Unknown

Nanjing Gulou Hospital, Nanjing

All Listed Sponsors
lead

Peking University

OTHER