A Study of GR1803 Injection in Combination With Anti-CD38 Monoclonal Antibody for the Treatment of Participants With Multiple Myeloma
- Conditions
- Multiple Myeloma
- Interventions
- Drug: GR1803 injectionDrug: Anti-CD38 Monoclonal Antibody
- Registration Number
- NCT07090954
- Lead Sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 32
- 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.
- Known allergies, hypersensitivity, or intolerance to the study drug or its excipients.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description GR1803 plus anti-CD38 monoclonal antibody GR1803 injection Participants will be assigned to a combination of anti-CD38 monocloncal antibody plus GR1803 injection. GR1803 plus anti-CD38 monoclonal antibody Anti-CD38 Monoclonal Antibody Participants will be assigned to a combination of anti-CD38 monocloncal antibody plus GR1803 injection.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Duration of Response Up to 2 Years Time from initial partial response or better to progressive disease or death due to any cause
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
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
Trial Locations
- Locations (2)
Shanghai Fourth People's Hospital Affiliated with Tongji University
🇨🇳Shanghai, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, China
Shanghai Fourth People's Hospital Affiliated with Tongji University🇨🇳Shanghai, ChinaJun W Fu, Doctor of MedicineContact86+13816052522fuweijun2010@hotmail.com