Phase I Trial of GR1803 Injection in Patients With RRMM
- Conditions
- Multiple Myeloma (MM)
- Interventions
- Drug: GR1803 injection
- Registration Number
- NCT07102706
- Lead Sponsor
- Genrix (Shanghai) Biopharmaceutical Co., Ltd.
- Brief Summary
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 52 weeks or until the subject withdraws consent or until the investigator determines that the subject needs to be discontinued.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 76
- ECOG score 0-2.
- ≥18 years of age.
- 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.
- Prior treatment with any BCMA-targeted therapy.
- Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
- Plasma cell leukemia , Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description 0.02ug/kg GR1803 GR1803 injection - 1ug/kg GR1803 GR1803 injection - 10ug/kg GR1803 GR1803 injection - 30ug/kg GR1803 GR1803 injection - 90ug/kg GR1803 GR1803 injection - 180ug/kg GR1803 GR1803 injection - 240ug/kg GR1803 GR1803 injection - 300ug/kg GR1803 GR1803 injection - 360ug/kg GR1803 GR1803 injection -
- Primary Outcome Measures
Name Time Method DLT 52 weeks Dose Limited Toxicity
- Secondary Outcome Measures
Name Time Method ORR 52 weeks Sum of the proportions of patients with proven strict complete remission (sCR), complete remission (CR), very good partial remission (VGPR) and partial remission (PR)
Progression-free survival (PFS) 52 weeks Time from enrollment to tumor progression or death from any cause
Trial Locations
- Locations (1)
The First Affiliated Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
The First Affiliated Hospital, Zhejiang University School of Medicine🇨🇳Hangzhou, Zhejiang, China