The aim of this study was to analyze the safety and efficacy of CD3-CD20 bispecific antibody-based therapy in combination with CD19-CAR-T cells for the treatment of relapsed and refractory B-cell Non-Hodgkin's (B-NHL) lymphoma. The main questions it aims to answer: 1. The safety of CD3-CD20 bispecific antibody-based therapy in combination with CD19-CAR-T cells in B-NHL; 2. The effect of different doses of bispecific antibody maintenance therapy on CAR-T cell expansion.
The study was divided into two phases: In the previous phase Ib clinical study, the bispecific antibody was used for bridging therapy to reduce the Neoplasm load, followed by CART cell therapy. After CART cell therapy, low-dose bispecific antibody was used for maintenance, in order to explore the safe resistance of bispecific antibody combined with CAR-T cell therapy and further explore the effect of bispecific antibody combined with CAR-T cell therapy on CART cell expansion; Phase II study will expand the sample study to further clarify whether bispecific antibody combined with CAR-T cell therapy can further deepen the efficacy of CAR-T.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
53
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.
Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
Incidence rate and severity of adverse events (AE) of patients treated with bispecific antibody combined with CD19-CAR-T cells in B-NHL.(Assessed by CTCAE criteria v5 and ASTCT 2019 criteria for CRS/ICANS adverse events.)
Assess the safety and toxicity of CD3-CD20 bispecific antibody-based therapy in combination with CD19-CAR-T cells in B-NHL. Assessed in all patients given at least one dose of study treatment and infused.
Time frame: Up to 30 days after last treatment.From registration and during the bridging treatment, until end of post-treatment safety reporting window (up to six months after last dose of glofitamab)
Complete Response (CR) Rate
Time frame: Up to 12 months after last treatment
Overall Response Rate (ORR)
Time frame: Up to 12 months after last treatment
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