6
Participants
Start Date
March 31, 2025
Primary Completion Date
September 30, 2025
Study Completion Date
May 30, 2026
Engineering of chimeric antigen receptors targeting CD19 in allogeneic T cells
"About 6 subjects will be included in the study, and a 3+3 dose escalation method will be used. The dosage will be gradually increased in two dose groups: 1 × 10 \^ 8 CAR-T cells/dose and 2 × 10 \^ 8 CAR-T cells/dose. Three subjects are enrolled in each dose group first, and within the same dose group, the cell transfusion interval between the first two subjects should not be less than 14 days. If no dose limiting toxicity (DLT) is observed in a certain dose group, the dose will be increased to the next dose; If one case of DLT occurs, this dose group needs to be divided into three additional subjects (a total of six subjects). If no new DLT occurs, the dosage will be increased to the next dose; If more than 1/6 of the 6 subjects develop DLT, the dose escalation will be terminated, and the Safety Review Committee (SRC) will discuss whether to reduce the dose and continue the monotherapy study."
Beijing Immunochina Medical Science & Technology Co., Ltd.
INDUSTRY