48
Participants
Start Date
March 10, 2025
Primary Completion Date
June 30, 2027
Study Completion Date
June 30, 2030
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.
Beijing Cancer Hospital, Beijing
Beijing Gaobo Hospital, Beijing
Nanjing Gulou Hospital, Nanjing
Peking University
OTHER