A Prospective Clinical Study of CD3-CD20 Bisspecific Antibody Based Therapy Combined With CD19-CAR T Cells in the Treatment of Relapsed Refractory B-cell Non-Hodgkin Lymphoma

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

April 30, 2024

Primary Completion Date

April 30, 2026

Study Completion Date

April 30, 2027

Conditions
B-cell Non-Hodgkin Lymphoma
Interventions
DRUG

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."

Trial Locations (1)

Unknown

RECRUITING

Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences, Tianjin

All Listed Sponsors
lead

Institute of Hematology & Blood Diseases Hospital, China

OTHER