Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug SHR-5421 takes on Hard-to-Treat multiple myeloma

NCT ID NCT07652281

Disease control Sponsor: Suzhou Suncadia Biopharmaceuticals 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jul 31, 2026 · Updated 3 times

Summary

This early-phase trial is testing a new drug, SHR-5421, in about 97 people with multiple myeloma that has come back or stopped responding to treatment. The main goal is to find a safe dose and check for side effects. Researchers will also look at how the drug moves through the body and whether it shows any signs of shrinking the cancer.

What this could mean

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

Active substance
SHR-5421
What this could lead to
If this works, it could point toward a new treatment option for people with multiple myeloma that has stopped responding to other therapies.
What could go wrong
This is a very early Phase 1 trial with only 97 people. It is designed mainly to check safety and find the right dose, not to prove the drug works. Many drugs fail at this stage.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 97 people

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

Started

Jul 2026

Expected to finish

Apr 2029

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 years and older

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. Age ≥ 18 years, male or female. 2. Expected survival ≥ 3 months. 3. ECOG performance status 0 or 1. 4. Diagnosed with active multiple myeloma per IMWG criteria. 5. Relapsed or refractory multiple myeloma and refractory to the most recent line of therapy. 6. Disease progression or non-response to the most recent therapy. 7. Measurable disease as defined by serum/urine M-protein or serum free light chain. 8. Adequate bone marrow, hepatic, renal, and coagulation function. 9. Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception. 10. Willing and able to provide written informed consent and comply with study procedures. Exclusion Criteria: 1. Diagnosis of amyloidosis, plasma cell leukemia, Waldenström's macroglobulinemia, or POEMS syndrome. 2. Central nervous system involvement by tumor. 3. History of ≥ Grade 3 CRS with prior T-cell redirecting therapy. 4. Requirement for dialysis or plasmapheresis within 14 days prior to study drug. 5. Prior treatment-related AEs not recovered to ≤ Grade 1 (except alopecia, peripheral neuropathy, or controlled endocrinopathies). 6. Concurrent participation in another clinical study. 7. Prior anti-tumor therapy within specified washout periods. 8. Major surgery within 28 days prior to informed consent or planned during the study. 9. Live attenuated vaccine within 4 weeks prior to first dose or planned during the study. 10. Significant comorbidity that in the investigator's judgment would interfere with study participation or safety. 11. Active autoimmune disease (except controlled type I diabetes, hypothyroidism, or vitiligo). 12. Active infection. 13. Known hypersensitivity or contraindication to SHR-5421.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Multiple myeloma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

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

    1 site. 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

  • Peking University People's Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100044, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.