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A Study of GR1803 Injection in Combination With Anti-CD38 Monoclonal Antibody for the Treatment of Participants With Multiple Myeloma

Not Applicable
Not yet recruiting
Conditions
Multiple Myeloma
Interventions
Drug: GR1803 injection
Drug: 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
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
GR1803 plus anti-CD38 monoclonal antibodyGR1803 injectionParticipants will be assigned to a combination of anti-CD38 monocloncal antibody plus GR1803 injection.
GR1803 plus anti-CD38 monoclonal antibodyAnti-CD38 Monoclonal AntibodyParticipants will be assigned to a combination of anti-CD38 monocloncal antibody plus GR1803 injection.
Primary Outcome Measures
NameTimeMethod
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 EventsUp 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 RateUp 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
NameTimeMethod
Duration of ResponseUp to 2 Years

Time from initial partial response or better to progressive disease or death due to any cause

Progression-Free SurvivalUp to 2 Years

Time from first administration of GR1803 injection to tumor progerssion or death from any cause

Serum Concentration of GR1803 InjectionUp to 2 Years

Serum concentration of GR1803 injection will be assessed

Number of Participants With Anti-Drug Antibodies to GR1803 InjectionUp 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, China
Jun W Fu, Doctor of Medicine
Contact
86+13816052522
fuweijun2010@hotmail.com

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