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This is a Phase 1, open-label, multi-center study to evaluate the safety of JMT601 in the treatment of relapsed or refractory CD20-positive B-cell non-Hodgkin lymphoma and to determine the recommended dose for Phase 2 studies (RP2D). Study consists of 2 parts. The first part is a dose-escalation part using a 3+3 design with up to 6 dose(0.3 mg/kg, 1 mg/kg, 3 mg/kg, 6 mg/kg, 12 mg/kg and 20 mg/kg) escalation cohorts at increasing levels. The second part is a dose-expansion part at R2PD dose to assess preliminary efficacy of JMT601.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JMT601 | Experimental | Subjects will receive JMT601 once a week. The first 4-week period is for DLT observation. Dose escalation part will be carried out according to 3+3 dose-escalation design with up to 6 dose(0.3 mg/kg, 1 mg/kg, 3 mg/kg, 6 mg/kg, 12 mg/kg and 20 mg/kg) escalation cohorts. Dose expansion part will continue at the determined RP2D. Dose expansion part consists of two cohorts: Cohort A: Subjects with CD20-positive diffuse large B-cell lymphoma, prior at least two lines of therapy. Cohort B: Subjects with CD20-positive follicular lymphoma, prior at least two lines of therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JMT601 | Biological | intravenous infusion on day 1 once a week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity(DLT) and maximum tolerated dose(MTD) | DLTs and MTD: Up to 28 days after the first dose | |
| Incidence of treatment-emergent adverse events (TEAEs) | TEAEs: Up to 90 days after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | Defined as the proportion of participants with complete response or partial response measured by Lugano 2014 | Up to 12 months |
| Duration of response (DOR) | Defined as the time from complete response or partial response to progression disease or death |
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Key Inclusion Criteria:
Participants diagnosed with CD20-positive B-cell non-Hodgkin lymphoma confirmed by histopathology and/or cell biology who have previously received 2 or more lines of therapy
Eastern Cooperative Oncology Group (ECOG) physical state score: 0-2
Participants must have at least one evaluable or measurable lesion according to Lugano 2014 criteria.
Expected survival of at least 3 months;
Suitable organ and hematopoietic function:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingjie Li | Contact | 86-15877976037 | liqingjie@cspc.cn |
| Name | Affiliation | Role |
|---|---|---|
| Weili Zhao | Ruijin Hospital Clinical, Shanghai Jiao Tong University, School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital | Recruiting | Shanghai | 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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| Up to 12 months |
| Progression free survival (PFS) | Defined as the time from initiation of treatment to progression disease or death | Up to 12 months |
| Overall survival (OS) | Defined as the time from initiation of treatment to death of any cause | Up to 12 months |
| Aera under the curve from 0 to the last measurable concentration(AUClast) | Aera under the curve from 0 to the last measurable concentration | Up to 12 months |
| Aera under the curve from 0 to the infinite time(AUC0-∞) | Aera under the curve from 0 to the infinite time | Up to 12 months |
| Time to maximum concentration(Tmax) | time to maximum concentration | Up to 12 months |
| Terminal phase half-life(T1/2) | terminal phase half-life | Up to 12 months |
| Clearance(CL) | clearance | Up to 12 months |
| Volume(Vd) | volume | Up to 12 months |
| Maximum concentration( Cmax) | maximum concentration | Up to 12 months |
| Minimum concentration(Cmin) | minimum concentration | Up to 12 months |
| Accumulation ratio(AR) | accumulation ratio | Up to 12 months |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |