NCT07652281
A Clinical Study of SHR-5421 in Patients With Multiple Myeloma
Recruiting · Phase 1 · Suzhou Suncadia Biopharmaceuticals Co., Ltd. · registry updated 2026-07-30
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Exclusion
- Diagnosis of amyloidosis, plasma cell leukemia, Waldenström's macroglobulinemia, or POEMS syndrome.
- Central nervous system involvement by tumor.
- 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.