Clinical trial · Interventional
GR1803 Injection in Patients With Relapsed/Refractory Multiple Myeloma
Single-Arm, Open, Multi-Center Phase II Clinical Trial of the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of GR1803 Injection in Patients With Relapsed/Refractory Multiple Myeloma
- 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)
All subjects will receive GR1803 injection until intolerable toxicity or investigator-assessed disease progression occurs (except in cases of disease progression due to discontinuation of the drug as a result of an adverse event) or until the subject has been administered the drug for 2 years or until the subject withdraws consent or until the investigator determines that the subject needs to be discontinued.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GR1803 injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- GR1803
- interventionNames
- Drug: GR1803 injection
Primary outcomes (1)
- measure
- ORR evaluated by IRC
- timeFrame
- 2 years
- description
- Sum of the proportions of patients with proven strict complete remission (sCR), complete remission (CR), very good partial remission (VGPR) and partial remission (PR)
Secondary outcomes (4)
- measure
- ORR evaluated by investigator
- timeFrame
- 2 years
- description
- Sum of the proportions of patients with proven strict complete remission (sCR), complete remission (CR), very good partial remission (VGPR) and partial remission (PR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 1、ECOG score 0-2 2、≥18 years of age 3、Multiple myeloma must be measurable by central laboratory assessment: Serum monoclonal paraprotein (M-protein) level ≥0.5 g/dL or urine M-protein level ≥200 mg/24 hours; or Light chain multiple myeloma without measurable disease in the serum or the urine: Serum immunoglobulin free light chain (FLC) ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio. Exclusion Criteria: * 1、Prior treatment with any BCMA-targeted therapy 2、Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma 3、Known allergies, hypersensitivity, or intolerance to the study drug (teclistamab) or its excipients 4、Plasma cell leukemia , Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis.
References
Publications (0)
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