NCT06464185

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• B-cell Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-04-30
• Primary completion: 2026-04-30
• Completion: 2027-04-30
• First posted: 2024-06-18
• Last updated: 2025-11-18

Locations

1 site across 1 country: China