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New antibody combo aims to stall multiple Myeloma's return

NCT ID NCT06508983

Disease control Sponsor: Hangzhou Sumgen Biotech Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This phase 3 trial tests whether adding an experimental drug called SG301 to two standard medications (pomalidomide and dexamethasone) can help people with multiple myeloma that has come back or stopped responding to treatment. About 360 adults aged 18–75 with measurable disease and prior therapy will receive either SG301 or a placebo alongside the standard drugs. The study measures safety, side effects, and how long the cancer stays under control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SG301 (a monoclonal antibody) combined with pomalidomide and dexamethasone
What this could lead to
If successful, this combination could offer a new treatment option that delays cancer progression in people with multiple myeloma that has returned or not responded to prior therapy.
What could go wrong
This is an early-stage phase 3 trial, so results are not yet known. The drug may cause side effects or fail to improve outcomes compared to standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 360 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Understand and voluntarily sign the informed consent form (ICF). 2. Males and females aged 18-75 years (inclusive) 3. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2 4. Expected survival time of ≥3 months. 5. Subjects had a documented diagnosis of multiple myeloma with evidence of measurable disease. 6. Subjects had received at least 1 prior lines of anti-myeloma therapy, which must include lenalidomide and a proteasome inhibitor (bortezomib, carfilzomib or ixazomib) given alone or in combination. 7. Subjects must have documented evidence of PD on or after the last regimen. 8. Adequate function of vital organs 9. Women of childbearing potential (WOCBP) must agree to follow instructions for methods of contraception for 4 weeks before the start of study treatment, for the duration of study treatment, and for 6 months after cessation of SG301 or 4 weeks after cessation of pomalidomide, whichever is longer. WOCBP must have 2 negative serum or urine pregnancy tests, one 10-14 days prior to start of study treatment and one 24 hours prior to the start of study treatment. Exclusion Criteria: 1. Primary refractory multiple myeloma defined as participants who had never achieved at least a minimal response (MR) with any treatment during the disease course. 2. Bone independent extramedullary disease at screening. 3. Subjects who are primary refractory to a prior CD38 monoclonal antibody therapy. 4. Previous exposure to pomalidomide. 5. Subject has received chemotherapy or small molecule antitumor therapy within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is shorter, before the first dose of study treatment; 6. Subject has received tumor biotherapy within 4 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is shorter, before the first dose of study treatment; 7. Subject has received investigational agents within 4 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is shorter (but not less than 14 days), before the first dose of study treatment; 8. Active hepatitis B, or C. 9. Known HIV infection. 10. Known active tuberculosis or positive treponema pallidum antibodies. 11. Subjects with clinical significant organ dysfunction that does not meet the study needs. 12. Previous allogenic stem cell transplant or autologous stem cell transplantation (ASCT) before the first dose of study treatment. 13. Known allergy to any component of the investigational medicinal product. 14. Any concurrent medical or psychiatric condition or disease (eg, active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease) that is likely to interfere with the study procedures or results or that, in the opinion of the investigator, would constitute a hazard for participating in this study.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Relapsed/refractory multiple myeloma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Chaoyang Hospital of Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, 100024, China

  • First Affiliated Hospital of Henan University of Science and Technology

    RECRUITING

    Luoyang, Henan, 471000, China

  • Guangzhou First People's Hospital

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, 510000, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, 450000, China

  • Shanxi Provincial Hospital

    RECRUITING

    Taiyuan, Shanxi, 030000, China

  • Sun Yat-sen University Cancer Center

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, 510000, China

  • The First Affiliated Hospital Of Soochow University

    RECRUITING

    Suzhou, Jiangsu, 215006, China

  • The Second Affiliated Hospital Of Xi an Jiaotong University (Xibei Hospital)

    RECRUITING

    Xi’an, Shanxi, 710000, China

  • The Second Affiliated Hospital Zhejiang University School Of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310056, China

  • Tianjin Cancer University Airport Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, 300060, China

  • Tianjin Medical University Cancer Institute & Hospital

    NOT_YET_RECRUITING

    Tianjin, Tianjin Municipality, 300060, China

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, 430000, China

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