RecruitingPhase 2NCT07081022

JS203 Combination Regimens in B-Cell Non-Hodgkin's Lymphoma

Sponsor

Shanghai Junshi Bioscience Co., Ltd.

Enrollment

180 participants

Start Date

Aug 17, 2025

Study Type

INTERVENTIONAL

Conditions

B-cell Non-Hodgkin's Lymphoma

Summary

To evaluate the preliminary efficacy of JS203 combined with standard regimens in patients with B-cell Non-Hodgkin's lymphoma

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

Age range: 18 to 80 years old (inclusive), both male and female are acceptable；
ECOG: 0-2；
B-cell non-Hodgkin's lymphoma expressing CD20 antigen that has been pathologically diagnosed；
At least one measurable lesion meeting the criteria specified in the Lugano 2014 response assessment； Acceptable organ function at screening；

Exclusion Criteria9

A history of severe allergy to monoclonal antibody therapy (or recombinant antibody-related fusion protein)；
Previously received CD20-CD3 bispecific antibody treatment；
Previous allogeneic hematopoietic stem cell transplantation；
Previous solid organ transplantation；
History of autoimmune diseases；
Patients with a history of macrophage activation syndrome (MAS)/ hemophagocytic lymphohistiocytosis (HLH)；
Patients with a history of progressive multifocal leukoencephalopathy (PML)；
A known or suspected history of CNS lymphoma (including primary or secondary)；
There is pleural effusion, peritoneal effusion or pericardial effusion that requires treatment (such as puncture or drainage)；

Interventions

DRUGJS203 in combination with gemcitabine and oxaliplatin

Gemcitabine and oxaliplatin 8 cycles (Q3W) and JS203 (21 days/cycle) Cycle 1 QW,Cycle 2 and therafter Q3W until progression or unacceptable toxicity.

DRUGJS203 in combination with ifosfamide, carboplatin and etoposide

Ifosfamide, carboplatin and etoposide, 3 cycles (Q3W) and JS203, Cycle 1 QW, Cycle 2 and therafter Q3W until trasnplant, progression or unacceptable toxicity.

DRUGJS203 in combination with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone

Rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone 6 cycles (Q3W) and JS203, 8 cycles (21 days/cycle), Cycle 1 QW, Cycle 2 to Cycle 8 Q3W.

DRUGJS203 combined with lenalidomide

lenalidomide,12 cycles, Cycle 1(Q3W), Cycle 2 to Cycle 12 (Q4W) and JS203, 12 cycles, Cycle 1 (21 days/cycle) QW, Cycle 2 to Cycle 12 (28 days/cycle) Q4W.