48
Participants
Start Date
April 30, 2024
Primary Completion Date
April 30, 2026
Study Completion Date
April 30, 2027
Bispecific antibody-based combined with CAR-T cell therapy
"lymphocytes collection, and bispecific antibody-based therapy will be performed after successful Lymphocytes collection: Obinutuzumab:1000mg, cycle 1 day 1(C1D1) ,IV.~Glofitamab: 2.5 mg, C1D8; 10 mg,C1D15 ; 30 mg,C2D1 and C3D1, IV. It can be combined with other Immunization therapy during the use of bispecific antibodies according to the patient's condition.~On C4D1, the patient will be pretreated with fludarabine and cyclophosphamide (FC) regimen, and then infused with CART cells at a specific dose of 4 \* 1000000/Kg. Bispecific antibody maintenance therapy will be initiated on month 1/2/3 after CART infusion. In Phase1 bispecific maintenance therapy will be divided into three dose groups, using a 3 + 3 dose escalation design. In Phase 2, bispecific maintenance therapy will be used at the MTD dose of Phase 1."
RECRUITING
Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences, Tianjin
Institute of Hematology & Blood Diseases Hospital, China
OTHER