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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Participants will receive GR1803 injection.
Participants will receive anti-CD38 monoclonal antibody.
Shanghai Fourth People's Hospital Affiliated with Tongji University
Shanghai, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
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.
Time frame: 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.
Time frame: 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
Time frame: Up to 2 Years
Duration of Response
Time from initial partial response or better to progressive disease or death due to any cause
Time frame: Up to 2 Years
Progression-Free Survival
Time from first administration of GR1803 injection to tumor progerssion or death from any cause
Time frame: Up to 2 Years
Serum Concentration of GR1803 Injection
Serum concentration of GR1803 injection will be assessed
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Time frame: 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
Time frame: Up to 2 Years