Multiple Myeloma
Conditions
Brief summary
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.
Interventions
DRUGGR1803 injection
Participants will receive GR1803 injection.
Participants will receive anti-CD38 monoclonal antibody.
Sponsors
Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * Known allergies, hypersensitivity, or intolerance to the study drug or its excipients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose Escalation: Number of Participants With Dose Limiting Toxicity (DLT) | Up to 2 Years | 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 | Up to 2 Years | 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 | Up to 2 Years | The percentage of participants who have a partial response or better according to the International Myeloma Working Group criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response | Up to 2 Years | Time from initial partial response or better to progressive disease or death due to any cause |
| Number of Participants With Anti-Drug Antibodies to GR1803 Injection | Up to 2 Years | Number of participants with anti-drug antibodies to GR1803 injection will be assessed |
| Progression-Free Survival | Up to 2 Years | Time from first administration of GR1803 injection to tumor progerssion or death from any cause |
| Serum Concentration of GR1803 Injection | Up to 2 Years | Serum concentration of GR1803 injection will be assessed |
Countries
China
Contacts
Primary ContactCheng P He, Doctor of Meicine
Outcome results
None listed