Multiple Myeloma
Conditions
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 of SHR-9539 Injection in patients with multiple myeloma.
Interventions
DRUGSHR-9539 for injection
SHR-9539 for dose escalation/dose extension
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RP2D of SHR-9539 injection | Approximately 24 months | Determination of the recommended phase 2 dose (RP2D) of SHR-9539 injection in patient with multiple myeloma. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of AE | Up to follow-up period, approximately 24 months | 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. |
| Cmax | Up to follow-up period, approximately 24 months | Maximum serum concentration |
| Tmax | Up to follow-up period, approximately 24 months | Time to reach maximum plasma concentration. |
| Overall Response Rate (ORR) | Up to follow-up period, approximately 24 months | ORR assessed by the IMWG response criteria. |
Countries
China
Contacts
CONTACTYang Wu
Outcome results
None listed