A Clinical Study of SHR-9539 in Patients With Multiple Myeloma
ConditionMultiple Myeloma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.
About this trial
This study is a multicenter, open-label, dose-escalation/dose-expansion clinical Phase I trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy profile of SHR-9539 Injection in patients with multiple myeloma.
Eligibility criteria
Qualifiers
Age ≥ 18 years on day of signing the Informed Consent Form;
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale；
Documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria ；
Have a life expectancy of at least 3 months；
Disqualifiers
Central nervous system (CNS) involvement of MM；
Diagnosis of amyloidosis, plasma cell leukemia, Wahl's macroglobulinemia, or POEMS syndrome;
Prior Grade 3 or higher CRS (Per ASTCT standards) related to any T cell redirection (eg, CD-3 redirection technology or CAR-T cell therapy).
Have other factors that may force the termination of the study, e.g., non-compliance with the protocol, other serious illnesses (including psychiatric illnesses) that require comorbid treatment, serious laboratory abnormalities, associated family or social factors, which would affect the safety of the subjects or the collection of data and samples, as determined by the investigator.
Trial design
Treatments tested in this trial
- SHR-9539 for injection
Treatment groups
138 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov