Multiple Myeloma (MM)
Conditions
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.
Interventions
DRUGGR1803 injection
weekly dose up to week 24 , biweekly dose from week 24 to week 36, and triweekly dose from week 36 to week 52
Sponsors
Genrix (Shanghai) Biopharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DLT | 52 weeks | Dose Limited Toxicity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Outcome results
None listed