A Clinical Study of SHR-9539 in Patients With Multiple Myeloma
NCT ID: NCT06484777
Last Updated: 2024-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
138 participants
INTERVENTIONAL
2024-08-07
2027-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SHR-9539 for injection
SHR-9539 for injection
SHR-9539 for dose escalation/dose extension
Interventions
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SHR-9539 for injection
SHR-9539 for dose escalation/dose extension
Eligibility Criteria
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Inclusion Criteria
2. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale；
3. Documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria ；
4. Have a life expectancy of at least 3 months；
5. 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 Criteria
2. Diagnosis of amyloidosis, plasma cell leukemia, Wahl's macroglobulinemia, or POEMS syndrome;
3. 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).
4. 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.
18 Years
ALL
No
Sponsors
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Suzhou Suncadia Biopharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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West China Hospital of Sichuan University
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SHR-9539-101
Identifier Type: -
Identifier Source: org_study_id
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