Tests SHR-5421 safety in adults with multiple myeloma
Tests the drug SHR-5421 for safety and effects in adults with multiple myeloma.
Plain-language title generated from the registry record
Registry title: A Clinical Study of SHR-5421 in Patients With Multiple Myeloma
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 1
Where in China
- Peking University People's HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Trial code
- NCT07652281
- Record updated
- 30 July 2026
- Original description
This is a Phase I, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of SHR-5421 in patients with multiple myeloma (MM).Read full original descriptionShow less
An Open-label, Multicenter, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SHR-5421 in Patients With Multiple Myeloma
This is a Phase I, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of SHR-5421 in patients with multiple myeloma (MM).
Inclusion: Age ≥ 18 years, male or female; Expected survival ≥ 3 months; ECOG performance status 0 or 1; Diagnosed with active multiple myeloma per IMWG criteria; Relapsed or refractory multiple myeloma and refractory to the most recent line of therapy; Disease progression or non-response to the most recent therapy; Measurable disease as defined by serum/urine M-protein or serum free light chain; Adequate bone marrow, hepatic, renal, and coagulation function; Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception; Willing and able to provide written informed consent and comply with study procedures.
Exclusion: History of ≥ Grade 3 CRS with prior T-cell redirecting therapy; Requirement for dialysis or plasmapheresis within 14 days prior to study drug; Prior treatment-related AEs not recovered to ≤ Grade 1 (except alopecia, peripheral neuropathy, or controlled endocrinopathies); Concurrent participation in another clinical study; Prior anti-tumor therapy within specified washout periods; Major surgery within 28 days prior to informed consent or planned during the study; Live attenuated vaccine within 4 weeks prior to first dose or planned during the study; Diagnosis of amyloidosis, plasma cell leukemia, Waldenström's macroglobulinemia, or POEMS syndrome; Active autoimmune disease (except controlled type I diabetes, hypothyroidism, or vitiligo); Active infection; Known hypersensitivity or contraindication to SHR-5421; Central nervous system involvement by tumor; Significant comorbidity that in the investigator's judgment would interfere with study participation or safety.