B-cell Non-Hodgkin's Lymphoma
Conditions
Brief summary
To evaluate the preliminary efficacy of JS203 combined with standard regimens in patients with B-cell Non-Hodgkin's lymphoma
Interventions
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.
Sponsors
Shanghai Junshi Bioscience Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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)；
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | up to approximately 15 months | Objective response rate (ORR) based on 2014 Lugano criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| complete response (CR) | up to approximately 24 months | The complete response rate (CR) evaluated based on 2014 Lugano criteria |
| Duration of response (DoR) | up to approximately 24 months | Duration of response (DoR) evaluated based on 2014 Lugano criteria |
| Duration of complete response (DoCR) | up to approximately 24 months | Duration of complete response (DoCR) evaluated based on 2014 Lugano criteria |
| Time to response (TTR) | up to approximately 24 months | Time to response (TTR) evaluated based on 2014 Lugano criteria |
| Progression-free survival (PFS) | up to approximately 24 months | Progression-free survival (PFS) evaluated based on 2014 Lugano criteria |
| Overall survival (OS) | up to approximately 24 months | Overall survival (OS) evaluated based on 2014 Lugano criteria |
| Adverse events (AE) | up to approximately 24 months | Incidence and severity of all adverse events (AE) that occurred during the clinical trial |
| PK | up to approximately 24 months | The serum drug concentration of JS203 |
| ADA | up to approximately 24 months | The incidence and titer of the anti-drug antibody (ADA) of JS203 |
| NAb | Up to approximately 24 months | The incidence of neutralizing antibodies (NAb) of JS203 (if applicable) |
Countries
China
Outcome results
None listed