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The purpose of this study is to identify recommended Phase 3 doses (RP3D) for treatment combination (GR1803 injection plus anti-CD38 monoclonal antibody) and to characterize the efficacy of RP3D for the treatment combination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GR1803 plus anti-CD38 monoclonal antibody | Experimental | Participants will be assigned to a combination of anti-CD38 monocloncal antibody plus GR1803 injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GR1803 injection | Drug | Participants will receive GR1803 injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Escalation: Number of Participants With Dose Limiting Toxicity (DLT) | The dose limiting toxicities are defined as any of the following events: drug related hematological or non-hematological toxicity of grade 3 or higher. | Up to 2 Years |
| Dose escalation: Number of Participants With Adverse Events and Serious Adverse Events | Adverse event is any untoward medical occurrence in a clinical trial participants administered a pharmaceutical product, regardless of causal relationship to the study treatment. This includes any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the product. Serious adverse event is an adverse event that results in any of the following outcomes: death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, other medically important events. | Up to 2 Years |
| Dose expansion: Overall Response Rate | The percentage of participants who have a partial response or better according to the International Myeloma Working Group criteria | Up to 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response | Time from initial partial response or better to progressive disease or death due to any cause | Up to 2 Years |
| Progression-Free Survival | Time from first administration of GR1803 injection to tumor progerssion or death from any cause |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cheng P He, Doctor of Meicine | Contact | 86+18991232609 | hepc_gcp@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Fourth People's Hospital Affiliated with Tongji University | Shanghai | China |
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| Anti-CD38 Monoclonal Antibody | Drug | Participants will receive anti-CD38 monoclonal antibody. |
|
| Up to 2 Years |
| Serum Concentration of GR1803 Injection | Serum concentration of GR1803 injection will be assessed | Up to 2 Years |
| Number of Participants With Anti-Drug Antibodies to GR1803 Injection | Number of participants with anti-drug antibodies to GR1803 injection will be assessed | Up to 2 Years |
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | China |
|
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| 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 |
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| ID | Term |
|---|---|
| C556306 | daratumumab |
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