Recruiting NCT07081022

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

Phase II Interventional B-cell Non-Hodgkin's Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: JS203 in combination with gemcitabine and oxaliplatin, JS203 in combination with ifosfamide, carboplatin and etoposide, JS203 in combination with rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone, JS203 combined with lenalidomide.
Who it may be relevant to: Registry conditions: B-cell Non-Hodgkin's Lymphoma. Basic parameters: 18 years — 80 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: China
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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

Drug 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.
Drug 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.
Drug 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.
Drug 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.

Secondary outcome measures (10)

complete response (CR) [Time frame: up to approximately 24 months]
Duration of response (DoR) [Time frame: up to approximately 24 months]
Duration of complete response (DoCR) [Time frame: up to approximately 24 months]
Time to response (TTR) [Time frame: up to approximately 24 months]
Progression-free survival (PFS) [Time frame: up to approximately 24 months]
Overall survival (OS) [Time frame: up to approximately 24 months]
Adverse events (AE) [Time frame: up to approximately 24 months]
PK [Time frame: up to approximately 24 months]
ADA [Time frame: up to approximately 24 months]
NAb [Time frame: Up to approximately 24 months]

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；

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)；

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

China · 1 center

NCT: NCT07081022 · JS203-002-II-B-NHL