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To evaluate the preliminary efficacy of JS203 combined with standard regimens in patients with B-cell Non-Hodgkin's lymphoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DLBCL-Gemox | Experimental | In participants with relapsed/refractory diffuse large B cell lymphoma ineligible for ASCT |
|
| DLBCL-ICE | Experimental | In participants with relapsed/refractory diffuse large B cell lymphoma intended for ASCT |
|
| DLBCL- RCHOP | Experimental | In participants with newly diagnosed diffuse large B cell lymphoma |
|
| FL-Lena | Experimental | In participants with relapsed/refractory follicular lymphoma |
|
| MCL-Lena | Experimental | In participants with relapsed/refractory mantle cell lymphoma |
|
| MZL-Lena |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JS203 in combination with gemcitabine and oxaliplatin | Drug | Gemcitabine and oxaliplatin 8 cycles (Q3W) and JS203 (21 days/cycle) Cycle 1 QW,Cycle 2 and therafter Q3W until progression or unacceptable toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Objective response rate (ORR) based on 2014 Lugano criteria | up to approximately 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| complete response (CR) | The complete response rate (CR) evaluated based on 2014 Lugano criteria | up to approximately 24 months |
| Duration of response (DoR) | Duration of response (DoR) evaluated based on 2014 Lugano criteria |
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Inclusion Criteria:
Patients must meet all of the following inclusion criteria to be enrolled:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bang.an Peng, Master | Contact | 13526844722 | bang.an_peng@junshipharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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In participants with relapsed/refractory marginal zone lymphoma |
|
| JS203 in combination with ifosfamide, carboplatin and etoposide | Drug | 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 | Drug | 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 | Drug | 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. |
|
| up to approximately 24 months |
| Duration of complete response (DoCR) | Duration of complete response (DoCR) evaluated based on 2014 Lugano criteria | up to approximately 24 months |
| Time to response (TTR) | Time to response (TTR) evaluated based on 2014 Lugano criteria | up to approximately 24 months |
| Progression-free survival (PFS) | Progression-free survival (PFS) evaluated based on 2014 Lugano criteria | up to approximately 24 months |
| Overall survival (OS) | Overall survival (OS) evaluated based on 2014 Lugano criteria | up to approximately 24 months |
| Adverse events (AE) | Incidence and severity of all adverse events (AE) that occurred during the clinical trial | up to approximately 24 months |
| PK | The serum drug concentration of JS203 | up to approximately 24 months |
| ADA | The incidence and titer of the anti-drug antibody (ADA) of JS203 | up to approximately 24 months |
| NAb | The incidence of neutralizing antibodies (NAb) of JS203 (if applicable) | Up to approximately 24 months |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D000077150 | Oxaliplatin |
| D007069 | Ifosfamide |
| D016190 | Carboplatin |
| D005047 | Etoposide |
| D000069283 | Rituximab |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D014750 | Vincristine |
| D011241 | Prednisone |
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D010078 | Oxazines |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D000617 | Aminoglycosides |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D054833 | Isoindoles |
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