Relapsed/Refractory Multiple MyelomaPhase 1/2NCT07454187
To Evaluate the Safety of SG2918 in Patients With Relapsed/Refractory Multiple Myeloma
A Phase 1/2 study testing SG2918 in people with Relapsed/Refractory Multiple Myeloma, run by Hangzhou Sumgen Biotech Co., Ltd. at 4 sites in China.
Trial summary
The primary objective of this study was to evaluate the safety and tolerability of SG2918 in patients with relapsed/refractory multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Relapsed/Refractory Multiple Myeloma
- What is being tested?
- SG2918
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesChina
- Study dates
- 16 Apr 2026to 31 Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
- Immunotherapy, macromolecular targeted therapy, or other antineoplastic biologic therapy within 28 days prior to the first dose.
- Cytotoxic chemotherapy or small molecule therapy within 14 days prior to the first dose.
- Modernized traditional Chinese herbal medicine with approved antineoplastic indications within 7 days prior to the first dose.
- 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.
- Administration of any live or live attenuated vaccine within 28 days prior to the first dose.
- Administration of other vaccines (e.g., inactivated COVID-19 vaccine) within 14 days prior to the first dose.
- Immune related toxicity during prior antineoplastic immunotherapy that resulted in permanent treatment discontinuation.
- Current or previous idiopathic pulmonary fibrosis or idiopathic pneumonia;
- Current acute pulmonary disease, interstitial lung disease, or pneumonia.
- Any other malignancy diagnosed within 5 years prior to the first dose.
- Documented history of neurological or psychiatric disorder.
- Any other condition that, in the opinion of the investigator, may render the participant unsuitable for study participation.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
The Second Affiliated Hospital Zhejiang University School Of Medicine
Hangzhou, Zhejiang, 310056
Wenbin Qian, Doctor, qianwenb@hotmail.com
- Recruiting
The First Affiliated Hospital Of Soochow University
Suzhou, Jiangsu, 215006
Zhengzheng Fu, Doctor, fuzhengzheng@suda.edu.cn
- Recruiting
The Second Affiliated Hospital Of Xi an Jiaotong University (Xibei Hospital)
Xi’an, Shanxi, 710000
Wanhong Zhao, Doctor, 13991365406@163.com
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Baijun Fang, Doctor, fdation@126.com
Yuzhang Liu, Doctor, hedajay@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Being tested
- SG2918
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SG2918Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| SG2918 monotherapy | Experimental | Not described Receives: Drug: SG2918 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events（AEs ）
Number and percentage of AEs which is calculated by worst CTCAE grade by CTCAE 6.0
Measured: From time Day1 of Cycle1 until 30 days after last dose of SG2918
Secondary outcomes (7)
Pharmacokinetics(PK): Cmax
Maximum drug concentration after administration
Measured: Through study completion, an average of one year
Pharmacokinetics (PK): T1/2
Elimination half-life of the drug after administration
Measured: Elimination half-life of the drug after administration
Pharmacokinetics (PK): AUC
Area Under the Curve of the drug after administration
Measured: Through study completion, an average of one year
Immunogenicity
Levels of anti-drug antibodies(ADAs) and neutralizing antibodies (tested in ADA-positive samples)
Measured: 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
Measured: Through study completion, an average of one year
PFS
Progression-Free Survival
Measured: 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.
Measured: Through study completion, an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start16 Apr 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Sumgen Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07454187
- Sponsor's protocol ID
- CSG-2918-102
- Status last verified
- Feb 2026
- First submitted
- 25 Feb 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07454187
- Acronym / sponsor ID
- CSG-2918-102
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hangzhou Sumgen Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Apr 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study was to evaluate the safety and tolerability of SG2918 in patients with relapsed/refractory multiple myeloma.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SG2918 monotherapy | Experimental | Drug: SG2918 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (27 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SG2918The 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. | Drug | SG2918 monotherapy |
Primary outcome
Incidence of Treatment-Emergent Adverse Events（AEs ）
Time frame: From time Day1 of Cycle1 until 30 days after last dose of SG2918
Number and percentage of AEs which is calculated by worst CTCAE grade by CTCAE 6.0
7 secondary outcomes
Pharmacokinetics(PK): Cmax
Time frame: Through study completion, an average of one year
Pharmacokinetics (PK): T1/2
Time frame: Elimination half-life of the drug after administration
Pharmacokinetics (PK): AUC
Time frame: Through study completion, an average of one year
Immunogenicity
Time frame: Through study completion, an average of one year
objective response rate(ORR)
Time frame: Through study completion, an average of one year
PFS
Time frame: Through study completion, an average of one year
MRD
Time frame: Through study completion, an average of one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SG2918 in people with Relapsed/Refractory Multiple Myeloma, run by Hangzhou Sumgen Biotech Co., Ltd. at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yue Song (+86-18511021346, songyue@sumgenbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events（AEs ） (time frame: From time Day1 of Cycle1 until 30 days after last dose of SG2918). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.