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Trial Title:
A Clinical Study of SHR-9539 in Patients With Multiple Myeloma
NCT ID:
NCT06484777
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-9539 for injection
Description:
SHR-9539 for dose escalation/dose extension
Arm group label:
SHR-9539 for injection
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 of SHR-9539 Injection in patients with multiple myeloma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥ 18 years on day of signing the Informed Consent Form;
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:
1. Central nervous system (CNS) involvement of MM；
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
West China Hospital of Sichuan University
Address:
City:
Chengdu
Zip:
610000
Country:
China
Status:
Recruiting
Contact:
Last name:
Ting Niu, Doctor
Phone:
+86-18980601242
Email:
Tingniu@sina.com
Start date:
August 7, 2024
Completion date:
July 31, 2027
Lead sponsor:
Agency:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Agency class:
Industry
Source:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06484777
