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All subjects will receive GR1803 injection until intolerable toxicity or investigator-assessed disease progression occurs (except in cases of disease progression due to discontinuation of the drug as a result of an adverse event) or until the subject has been administered the drug for 52 weeks or until the subject withdraws consent or until the investigator determines that the subject needs to be discontinued.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.02ug/kg GR1803 | Experimental |
| |
| 1ug/kg GR1803 | Experimental |
| |
| 10ug/kg GR1803 | Experimental |
| |
| 30ug/kg GR1803 | Experimental |
| |
| 90ug/kg GR1803 | Experimental |
| |
| 180ug/kg GR1803 | Experimental |
| |
| 240ug/kg GR1803 | Experimental |
| |
| 300ug/kg GR1803 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GR1803 injection | Drug | weekly dose up to week 24 , biweekly dose from week 24 to week 36, and triweekly dose from week 36 to week 52 |
|
| Measure | Description | Time Frame |
|---|---|---|
| DLT | Dose Limited Toxicity | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Sum of the proportions of patients with proven strict complete remission (sCR), complete remission (CR), very good partial remission (VGPR) and partial remission (PR) | 52 weeks |
| Progression-free survival (PFS) |
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Inclusion Criteria:
Serum monoclonal paraprotein (M-protein) level ≥0.5 g/dL or urine M-protein level ≥200 mg/24 hours; or
Light chain multiple myeloma without measurable disease in the serum or the urine:
Serum immunoglobulin free light chain (FLC) ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jie Jin, PhD | First Affiliated Hospital of Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310003 | China |
Study Protocol
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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|
| 360ug/kg GR1803 | Experimental |
|
Time from enrollment to tumor progression or death from any cause
| 52 weeks |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |