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

The primary objective of this study was to evaluate the safety and tolerability of SG2918 in patients with relapsed/refractory multiple myeloma.

Study Overview

• Status: Not yet recruiting
• Conditions: Relapsed/Refractory Multiple Myeloma
• Intervention / Treatment: Drug: SG2918

Detailed Description

This is a multicenter, open-label, dose-escalation and dose-expansion Phase Ib/II clinical study of SG2918 conducted in Chinese patients with relapsed/refractory multiple myeloma.The primary objective of this study is to evaluate the safety and tolerability of SG2918 in patients with relapsed/refractory multiple myeloma.Secondary objectives include exploring the efficacy, pharmacokinetic profile, pharmacodynamics, and immunogenicity of SG2918.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Yue Song; Phone Number: +86-18511021346; Email: songyue@sumgenbio.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Henan Cancer Hospital
      • Contact: Baijun Fang, Doctor; Email: fdation@126.com
      • Contact: Yuzhang Liu, Doctor; Email: hedajay@163.com
  • Jiangsu
    • Suzhou, Jiangsu, China, 215006
      • The First Affiliated Hospital of Soochow University
      • Contact: Zhengzheng Fu, Doctor; Email: fuzhengzheng@suda.edu.cn
  • Shanxi
    • Xi’an, Shanxi, China, 710000
      • The Second Affiliated Hospital Of Xi an Jiaotong University (Xibei Hospital)
      • Contact: Wanhong Zhao, Doctor; Email: 13991365406@163.com
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310056
      • The Second Affiliated Hospital Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years and ≤ 80 years.
2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
3. Life expectancy ≥ 3 months.
4. Documented diagnosis of multiple myeloma.
5. Measurable disease at screening (per IMWG criteria).
6. Relevant laboratory values obtained within 7 days prior to the first dose must meet protocol-specified thresholds.
7. Resolution of adverse events related to prior antineoplastic therapy to Grade ≤ 1 or baseline (CTCAE v6.0).
8. 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.
9. 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.

Exclusion Criteria:

1. Patients with primary refractory multiple myeloma.
2. Presence of non-bone-related extramedullary soft tissue plasmacytoma at screening.
3. known meningeal or Central Nervous System involvement of multiple myeloma, or high suspicion of unconfirmed meningeal or Central Nervous System involvement.
4. History of peripheral neuropathy of Grade ≥ 2.
5. Active infection requiring systemic therapy within 2 weeks prior to the first dose.
6. Hypertension that was not effectively controlled by standardized antihypertensive treatment within 2 weeks prior to the first dose, as judged by the investigator
7. History of hypertensive crisis or hypertensive encephalopathy.
8. Poorly controlled diabetes mellitus.
9. Severe cardiovascular or cerebrovascular disease within 6 months prior to the first dose.
10. Active hepatitis B or hepatitis C infection.
11. Known history of active tuberculosis or active syphilis.
12. Known hypersensitivity to any component of the investigational product.
13. history of Grade 3-4 allergic reaction or life threatening hypersensitivity to any biological product.

14. Received any of the following therapies or surgeries.

    1. Prior treatment with LILRB4 targeted therapy; or severe adverse reaction to prior MMAE containing therapy.
    2. Immunotherapy, macromolecular targeted therapy, or other antineoplastic biologic therapy within 28 days prior to the first dose.
    3. Cytotoxic chemotherapy or small molecule therapy within 14 days prior to the first dose.
    4. Modernized traditional Chinese herbal medicine with approved antineoplastic indications within 7 days prior to the first dose.
15. Requirement for systemic corticosteroids (equivalent to > 10 mg prednisone per day) or other immunosuppressive agents within 14 days prior to the first dose or during the study.
16. Administration of any live or live attenuated vaccine within 28 days prior to the first dose.
17. Administration of other vaccines (e.g., inactivated COVID-19 vaccine) within 14 days prior to the first dose.
18. Immune related toxicity during prior antineoplastic immunotherapy that resulted in permanent treatment discontinuation.
19. Current or previous idiopathic pulmonary fibrosis or idiopathic pneumonia;
20. Current acute pulmonary disease, interstitial lung disease, or pneumonia.
21. Any other malignancy diagnosed within 5 years prior to the first dose.
22. Documented history of neurological or psychiatric disorder.
23. Any other condition that, in the opinion of the investigator, may render the participant unsuitable for study participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SG2918 monotherapy	Drug: SG2918; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics(PK): Cmax	Maximum drug concentration after administration	Through study completion, an average of one year
Pharmacokinetics (PK): T1/2	Elimination half-life of the drug after administration	Elimination half-life of the drug after administration
Pharmacokinetics (PK): AUC	Area Under the Curve of the drug after administration	Through study completion, an average of one year
Immunogenicity	Levels of anti-drug antibodies(ADAs) and neutralizing antibodies (tested in ADA-positive samples)	Through study completion, an average of one year
objective response rate(ORR)	percentage of participants with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) as best overall response	Through study completion, an average of one year
PFS	Progression-Free Survival	Through study completion, an average of one year
MRD	assessed by next-generation sequencing in bone marrow samples from participants who achieved CR or sCR, to determine the depth of response at the molecular level.	Through study completion, an average of one year

Collaborators and Investigators

• Sponsor: Hangzhou Sumgen Biotech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): March 14, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: February 25, 2026
• First Submitted That Met QC Criteria: March 3, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hemic and Lymphatic Diseases; Multiple Myeloma
• Other Study ID Numbers: CSG-2918-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No