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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
SHR-9539 for injection
DrugSHR-9539 for dose escalation/dose extension
Treatment groups
138 Participants
are divided into 1 treatment groupGroup A: SHR-9539 for injectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
RP2D of SHR-9539 injection
Determination of the recommended phase 2 dose (RP2D) of SHR-9539 injection in patient with multiple myeloma.
Time frame
Approximately 24 monthsSecondary outcomes
1
Incidence and severity of AE
Assessing the incidence of adverse events (AEs) mainly using the Common Terminology Criteria for Adverse Events (CTCAE Version 5), and CRS and ICANS were graded according to ASTCT standards.
Time frame
Up to follow-up period, approximately 24 months2
Cmax
Maximum serum concentration
Time frame
Up to follow-up period, approximately 24 months3
Tmax
Time to reach maximum plasma concentration.
Time frame
Up to follow-up period, approximately 24 months4
Overall Response Rate (ORR)
ORR assessed by the IMWG response criteria.
Time frame
Up to follow-up period, approximately 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov