Status:
RECRUITING
A Clinical Study of SHR-9539 in Patients With Multiple Myeloma
Lead Sponsor:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 o...
Eligibility Criteria
Inclusion
- 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；
- Male and female subjects with fertility must agree to use efficient contraceptive measures with their partners within 3 months after the last administration of the test drug from the time of signing the informed consent form, and have no fertility plan and avoid donating sperm / eggs. The pregnancy test during the screening period must be negative.
Exclusion
- 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.
Key Trial Info
Start Date :
August 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT06484777
Start Date
August 7 2024
End Date
July 31 2027
Last Update
August 9 2024
Active Locations (1)
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1
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610000