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

Shanghai Junshi Biosciences

Status and phase: Begins enrollment this month; Phase 2

Conditions: B-cell Non-Hodgkin's Lymphoma

Treatments: Drug: JS203 in combination with ifosfamide, carboplatin and etoposide; Drug: JS203 in combination with gemcitabine and oxaliplatin; Drug: JS203 in combination with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone; Drug: JS203 combined with lenalidomide

Study type: Interventional

Funder types: Other

Identifiers

NCT07081022

JS203-002-II-B-NHL

Details and patient eligibility

About

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

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients must meet all of the following inclusion criteria to be enrolled：

• 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 criteria

• 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)；

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 6 patient groups

DLBCL-Gemox

Experimental group

Description:

In participants with relapsed/refractory diffuse large B cell lymphoma ineligible for ASCT

Treatment:

Drug: JS203 in combination with gemcitabine and oxaliplatin

DLBCL-ICE

Experimental group

Description:

In participants with relapsed/refractory diffuse large B cell lymphoma intended for ASCT

Treatment:

Drug: JS203 in combination with ifosfamide, carboplatin and etoposide

DLBCL- RCHOP

Experimental group

Description:

In participants with newly diagnosed diffuse large B cell lymphoma

Treatment:

Drug: JS203 in combination with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone

FL-Lena

Experimental group

Description:

In participants with relapsed/refractory follicular lymphoma

Treatment:

Drug: JS203 combined with lenalidomide

MCL-Lena

Experimental group

Description:

In participants with relapsed/refractory mantle cell lymphoma

Treatment:

Drug: JS203 combined with lenalidomide

MZL-Lena

Experimental group

Description:

In participants with relapsed/refractory marginal zone lymphoma

Treatment:

Drug: JS203 combined with lenalidomide