To Evaluate the Safety of SG2918 in Patients With Relapsed/Refractory Multiple Myeloma
A Phase 1b/2 Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SG2918 for Injection in Patients With Relapsed/Refractory Multiple Myeloma
1 other identifier
interventional
40
1 country
4
Brief Summary
The primary objective of this study was to evaluate the safety and tolerability of SG2918 in patients with relapsed/refractory multiple myeloma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2026
Typical duration for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2026
CompletedFirst Posted
Study publicly available on registry
March 6, 2026
CompletedStudy Start
First participant enrolled
March 14, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
March 6, 2026
February 1, 2026
1.5 years
February 25, 2026
March 3, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of Treatment-Emergent Adverse Events（AEs ）
Number and percentage of AEs which is calculated by worst CTCAE grade by CTCAE 6.0
From time Day1 of Cycle1 until 30 days after last dose of SG2918
Secondary Outcomes (7)
Pharmacokinetics(PK): Cmax
Through study completion, an average of one year
Pharmacokinetics (PK): T1/2
Elimination half-life of the drug after administration
Pharmacokinetics (PK): AUC
Through study completion, an average of one year
Immunogenicity
Through study completion, an average of one year
objective response rate(ORR)
Through study completion, an average of one year
- +2 more secondary outcomes
Study Arms (1)
SG2918 monotherapy
EXPERIMENTALInterventions
The 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.
Eligibility Criteria
You may qualify if:
- 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.
- Measurable disease at screening (per IMWG criteria).
- Relevant laboratory values obtained within 7 days prior to the first dose must meet protocol-specified thresholds.
- Resolution of adverse events related to prior antineoplastic therapy to Grade ≤ 1 or baseline (CTCAE v6.0).
- Female participants of childbearing potential and male participants whose partners are of childbearing potential must use at least one acceptable method of contraception during study treatment and for at least 7 months after the last dose.
- Male participants must refrain from sperm donation from the signing of the Informed Consent Form (ICF) until at least 7 months after the last study dose.
You may not qualify if:
- 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.
- Active infection requiring systemic therapy within 2 weeks prior to the first dose.
- Hypertension that was not effectively controlled by standardized antihypertensive treatment within 2 weeks prior to the first dose, as judged by the investigator
- History of hypertensive crisis or hypertensive encephalopathy.
- Poorly controlled diabetes mellitus.
- Severe cardiovascular or cerebrovascular disease within 6 months prior to the first dose.
- Active hepatitis B or hepatitis C infection.
- Known history of active tuberculosis or active syphilis.
- Known hypersensitivity to any component of the investigational product.
- history of Grade 3-4 allergic reaction or life threatening hypersensitivity to any biological product.
- Received any of the following therapies or surgeries.
- Prior treatment with LILRB4 targeted therapy; or severe adverse reaction to prior MMAE containing therapy.
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
The First Affiliated Hospital Of Soochow University
Suzhou, Jiangsu, 215006, China
The Second Affiliated Hospital Of Xi an Jiaotong University (Xibei Hospital)
Xi’an, Shanxi, 710000, China
The Second Affiliated Hospital Zhejiang University School Of Medicine
Hangzhou, Zhejiang, 310056, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2026
First Posted
March 6, 2026
Study Start
March 14, 2026
Primary Completion (Estimated)
September 30, 2027
Study Completion (Estimated)
December 31, 2028
Last Updated
March 6, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share