A Clinical Study of SHR-5421 in Patients With Multiple Myeloma
ConditionMultiple Myeloma
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.
About this trial
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).
Eligibility criteria
Qualifiers
Age ≥ 18 years, male or female.
Expected survival ≥ 3 months.
ECOG performance status 0 or 1.
Diagnosed with active multiple myeloma per IMWG criteria.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- SHR-5421 for Injection
Treatment groups
97 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov