90
Participants
Start Date
November 9, 2024
Primary Completion Date
February 28, 2026
Study Completion Date
February 28, 2027
CAR-T Cells infusion(CAR2219,CAR2019, CAR19 etc)
"Phase I study: dose-escalation component.This part follows the 3+3 dose-escalation model, with 5 dose groups: 1×10\^6, 1.5×10\^6, 2×10\^6, 2.5×10\^6, 3×10\^6 CAR+ cells/kg (different target CAR-T can be adjusted by the investigator according to the dose used in the previous clinical trial). Each dose group enrolled 3\~6 patients with relapsed/refractory hematological diseases respectively, totaling 15\~30 subjects, in order to evaluate the safety of CAR-T cells for the treatment of relapsed/refractory malignant hematological neoplasms and to determine the MTD. Phase II study: dose-expansion portion. After the MTD was confirmed, in the dose-expansion portion of the study (Phase II), it was expected that 65\~60 subjects would receive the CAR-T cell injection infusion under RP2D to further evaluate the efficacy of CAR-T cell injection."
RECRUITING
TianJin China. TianJin Medical University General, Tianjin
Hebei Taihe Chunyu Biotechnology Co., Ltd
INDUSTRY
Tianjin Medical University General Hospital
OTHER