The primary objective of this study was to evaluate the safety and tolerability of SG2918 in patients with relapsed/refractory multiple myeloma.
Age ≥ 18 years and ≤ 80 years.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
Life expectancy ≥ 3 months.
Documented diagnosis of multiple myeloma.
Patients with primary refractory multiple myeloma.
Presence of non-bone-related extramedullary soft tissue plasmacytoma at screening.
known meningeal or Central Nervous System involvement of multiple myeloma, or high suspicion of unconfirmed meningeal or Central Nervous System involvement.
History of peripheral neuropathy of Grade ≥ 2.
Single group
SG2918
DrugThe study adopts a "3+3" dosing escalation approach. Initially, three dose groups are set, namely 1.5mg/kg, 1.8mg/kg, and 2mg/kg. The SG2918 will be administrated by intravenous infusion every 3 weeks.
Incidence of Treatment-Emergent Adverse Events（AEs ）
Number and percentage of AEs which is calculated by worst CTCAE grade by CTCAE 6.0
Pharmacokinetics(PK): Cmax
Maximum drug concentration after administration
Pharmacokinetics (PK): T1/2
Elimination half-life of the drug after administration
Pharmacokinetics (PK): AUC
Area Under the Curve of the drug after administration
Immunogenicity
Levels of anti-drug antibodies(ADAs) and neutralizing antibodies (tested in ADA-positive samples)
Click on the lead sponsor to view all of their trials.
