SHR-5421 in Relapsed or Refractory Multiple Myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, multicenter phase 1 trial evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of SHR-5421 given by injection in adults with active multiple myeloma who have progressed after prior therapy. The study will enroll patients with measurable disease and adequate organ function, and will closely monitor adverse events and clinical responses. Primary goals focus on safety and dosing, with secondary observations on pharmacology and early signals of antitumor activity. The trial is sponsored by Suzhou Suncadia Biopharmaceuticals with a participating site at Peking University People’s Hospital in Beijing.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University People's Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Junli Wang
• Email: junli.wang@hengrui.com
• Phone: +86-0518-82342973

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• 6MW5311 in adults with relapsed or refractory blood cancers

  This study tests increasing doses of 6MW5311 in adults with multiple myeloma, AML, or CMML to see if it is safe and tolerable and to find a suitable dose for later studies.

  Recruiting Phase 1 Mabwell (Shanghai) Bioscience Co., Ltd. · Shanghai, Shanghai Municipality · NCT07914556

• Tailored exercise program to improve quality of life for adults with hematologic cancers

  This pilot trial tests a personalized 16-week exercise program to see if it’s feasible and helpful for adults with acute myeloid leukemia, lymphoma, or multiple myeloma after first-line treatment.

  Recruiting Gruppo Italiano Malattie EMatologiche dell'Adulto · Roma, Rm and 2 other locations · NCT07912684

• Aspirin vs. rivaroxaban for blood clot prevention in newly diagnosed multiple myeloma

  In newly diagnosed multiple myeloma patients on IMiD-based therapy, this study tests whether aspirin or rivaroxaban is better at preventing blood clots.

  Recruiting Phase 4 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07907211

• Exercise phenotyping before chemotherapy in newly diagnosed multiple myeloma

  This observational study tests whether some newly diagnosed multiple myeloma patients with normal resting heart function already show limited exercise capacity, and whether that limitation relates to subtle heart tissue changes and future heart-related outcomes.

  Recruiting Technical University of Munich · Munich, Bavaria · NCT07851493

• SMS text check-ins to track symptoms for people with plasma cell disorders

  This study tests whether daily SMS symptom prompts are feasible and acceptable for adults starting treatment for multiple myeloma or AL amyloidosis.

  Recruiting Mayo Clinic · Rochester, Minnesota · NCT07850284

• Cevostamab with Pomalidomide and Dexamethasone after BCMA-directed CAR T therapy in multiple myeloma

  This study tests if Cevostamab combined with pomalidomide and dexamethasone can help people with multiple myeloma who have already had CAR T therapy and several prior treatments.

  Recruiting at 5 sites Phase 2 Hoffmann-La Roche · Nuremberg, Bavaria and 4 other locations · NCT07825064

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.