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This is an open phase I clinical study to evaluate the safety, tolerability, pharmacokinetic (PK) profile, pharmacodynamic (PD) profile, immunogenicity, and preliminary efficacy of JS203 in patients with relapsed/refractory B-cell non-Hodgkin's lymphoma. The study is divided into three phases: a dose-escalation phase, a dose-expansion phase, and an efficacy expansion phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JS203 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JS203 for Injection | Drug | 2-steps:JS203 for Injection is administered on the first and eighth day of the first cycle and every 3 weeks thereafter. 3-steps:JS203 for Injection is administered on the first, eighth and fifteenth day of the first cycle and every 3 weeks thereafter. 4-steps:JS203 for Injection is administered on the first, eighth, fifteenth and twenty-second day of the first cycle and every 3 weeks thereafter. |
| Measure | Description | Time Frame |
|---|---|---|
| MTD | It is suitable for dose escalation and dose extension.If the number of DLT patients is 0 and the next higher dose is unacceptable, the current dose is declared MTD. | Throughout the dose escalation and dose expansion phases,, an average of 1.5 years |
| RP2D | It is suitable for dose escalation and dose extension.RP2D will be determined based on a combination of safety, tolerability, PK and/or pharmacodynamic studies . | Throughout the dose escalation and dose expansion phases, an average of 1.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| DLT events | Incidence and severity of DLT events. | Up to 2 years |
| Adverse events (AEs) | Incidence and severity of adverse events (AEs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuqin Song, MD | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
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| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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|
| Up to 2 years |
| Serious adverse events (SAEs) | Incidence and severity of serious adverse events (SAEs). | Up to 2 years |
| abnormal changes in clinically significant laboratory tests and other examinations | abnormal changes in clinically significant laboratory tests and other examinations | Up to 2 years |
| Objective Response Rate (ORR) | Objective Response Rate (ORR) as Assessed by Investigator according to Lugano 2014 | Up to 2 years |
| Complete Response (CR) | Complete Response (CR) as Assessed by Investigator according to Lugano 2014 | Up to 2 years |
| Duration of Objective Response (DOR) | Duration of Objective Response (DOR) as Assessed by Investigator | Up to 2 years |
| Duration of Complete Response (DOCR) | Duration of Complete Response (DOCR) as Assessed by Investigator | Up to 2 years |
| Time to Response(TTR) | Time to Response(TTR) as Assessed by Investigator | Up to 2 years |
| Progression-Free Survival (PFS) | Progression-Free Survival (PFS) as Determined by Investigator | Up to 2 years |
| Overall Survival (OS) | Overall Survival (OS) | Up to 2 years |
| Antidrug antibodies (ADA) and/or neutralizing antibodies (Nab) | incidence of antidrug antibodies (ADA) and/or neutralizing antibodies (Nab) | At pre-defined intervals up to 2 years |
| Total exposure(AUC) of JS203 | Total exposure(AUC) of JS203 | At pre-defined intervals up to 2 years |
| Maximum Plasma Concentration (Cmax) of JS203 | Maximum Plasma Concentration (Cmax) of JS203 | At pre-defined intervals up to 2 years |
| Half-life(T1/2) of JS203 | Half-life(T1/2) of JS203 | At pre-defined intervals up to 2 years |
| Clearance(CL) of JS203 | Clearance(CL) of JS203 | At pre-defined intervals up to 2 years |
| Volume of Distribution (Vss) of JS203 | Volume of Distribution (Vss) of JS203 | At pre-defined intervals up to 2 years |
| Pharmacodynamic (PD) characteristics | CD20 receptor occupancy rate in peripheral blood cells | At pre-defined interval up to 2 years |
| Pharmacodynamic (PD) characteristics | Changes in peripheral blood immune cell subtypes (B cells, T cells) before and after drug administration. | At pre-defined interval up to 2 years |
| Pharmacodynamic (PD) characteristics | Changes in peripheral blood cytokines (IL-2, IL-4, IL-6, IL-10, TNF-α, IFN-γ) before and after drug administration | At pre-defined interval up to 2 years |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |