A Study of GR1803 Injection in Combination With Anti-CD38 Monoclonal Antibody for the Treatment of Participants With Multiple Myeloma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GR1803 injection, Anti-CD38 Monoclonal Antibody.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-Label, Multicenter, Phase Ib/II Clinical Trial of GR1803 Injection in Combination With an Anti-CD38 Monoclonal Antibody Evaluating Safety, Pharmacokinetics, Immunogenicity, and Preliminary Efficacy in Subjects With Relapsed/Refractory Multiple Myeloma Previously Treated With at Least One Line of Therapy Including Lenalidomide and a Proteasome Inhibitor
Overview
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
- Drug GR1803 injection
Participants will receive GR1803 injection. - Drug Anti-CD38 Monoclonal Antibody
Participants will receive anti-CD38 monoclonal antibody.
Primary outcome measures
- Dose Escalation: Number of Participants With Dose Limiting Toxicity (DLT) [Time frame: Up to 2 Years]
- Dose escalation: Number of Participants With Adverse Events and Serious Adverse Events [Time frame: Up to 2 Years]
- Dose expansion: Overall Response Rate [Time frame: Up to 2 Years]
Secondary outcome measures (4)
- Duration of Response [Time frame: Up to 2 Years]
- Progression-Free Survival [Time frame: Up to 2 Years]
- Serum Concentration of GR1803 Injection [Time frame: Up to 2 Years]
- Number of Participants With Anti-Drug Antibodies to GR1803 Injection [Time frame: Up to 2 Years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Shanghai Fourth People's Hospital Affiliated with Tongji University — Shanghai
- The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an
Identifiers
NCT: NCT07090954 · GR1803-003