Clinical trial · Interventional
A Study of GR1803 Injection in Combination With Anti-CD38 Monoclonal Antibody for the Treatment of Participants With Multiple Myeloma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-CD38 Monoclonal Antibody | Drug | — | UNRESOLVED |
| GR1803 injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GR1803 plus anti-CD38 monoclonal antibody
- description
- Participants will be assigned to a combination of anti-CD38 monocloncal antibody plus GR1803 injection.
- interventionNames
- Drug: GR1803 injection
- Drug: Anti-CD38 Monoclonal Antibody
Primary outcomes (3)
- measure
- Dose Escalation: Number of Participants With Dose Limiting Toxicity (DLT)
- timeFrame
- Up to 2 Years
- description
- The dose limiting toxicities are defined as any of the following events: drug related hematological or non-hematological toxicity of grade 3 or higher.
- measure
- Dose escalation: Number of Participants With Adverse Events and Serious Adverse Events
- timeFrame
- Up to 2 Years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available