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.
Eastern Cooperative Oncology Group performance status grade of 0, 1 or 2;
Diagnosis of multiple myeloma；have received at least one prior line of therapy including Lenalidomide and a proteasome inhibitor.
Able to understand and comply with the requirements of the clinical protocol, voluntarily participate in the clinical trial, and sign informed consent.
Plasma cell leukemia , Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or amyloidosis.
Active central nervous system involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
Prior treatment with any BCMA-targeted therapiy.
Active infecion.
Sequential
GR1803 injection
DrugParticipants will receive GR1803 injection.
Anti-CD38 Monoclonal Antibody
DrugParticipants will receive anti-CD38 monoclonal antibody.
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.
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.
Dose expansion: Overall Response Rate
The percentage of participants who have a partial response or better according to the International Myeloma Working Group criteria
Duration of Response
Time from initial partial response or better to progressive disease or death due to any cause
Progression-Free Survival
Time from first administration of GR1803 injection to tumor progerssion or death from any cause
Serum Concentration of GR1803 Injection
Serum concentration of GR1803 injection will be assessed
Number of Participants With Anti-Drug Antibodies to GR1803 Injection
Number of participants with anti-drug antibodies to GR1803 injection will be assessed
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