JS203 Combination Regimens in B-Cell Non-Hodgkin's Lymphoma
NCT ID: NCT07081022
Last Updated: 2025-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
180 participants
INTERVENTIONAL
2025-08-17
2027-04-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DLBCL-Gemox
In participants with relapsed/refractory diffuse large B cell lymphoma ineligible for ASCT
JS203 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.
DLBCL-ICE
In participants with relapsed/refractory diffuse large B cell lymphoma intended for ASCT
JS203 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.
DLBCL- RCHOP
In participants with newly diagnosed diffuse large B cell lymphoma
JS203 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.
FL-Lena
In participants with relapsed/refractory follicular lymphoma
JS203 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.
MCL-Lena
In participants with relapsed/refractory mantle cell lymphoma
JS203 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.
MZL-Lena
In participants with relapsed/refractory marginal zone lymphoma
JS203 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.
Interventions
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JS203 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.
JS203 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.
JS203 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.
JS203 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)；
18 Years
80 Years
ALL
No
Sponsors
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Shanghai Junshi Bioscience Co., Ltd.
OTHER
Responsible Party
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Locations
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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JS203-002-II-B-NHL
Identifier Type: -
Identifier Source: org_study_id
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