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ACTIVE NOT RECRUITING
NCT06464185
PHASE1/PHASE2

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

Sponsor: Institute of Hematology & Blood Diseases Hospital, China

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2024-04-30

Completion Date

2027-04-30

Last Updated

2025-11-18

Healthy Volunteers

No

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.

Locations (1)

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

Tianjin, Tianjin Municipality, China