A Clinical Study of SHR-9539 in Patients With Multiple Myeloma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-9539 for injection.
- Who it may be relevant to
- Registry conditions: Multiple Myeloma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-label, Multi-center Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of SHR-9539 Injection in Patients With Multiple Myeloma
Overview
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
- Drug SHR-9539 for injection
SHR-9539 for dose escalation/dose extension
Primary outcome measures
- RP2D of SHR-9539 injection [Time frame: Approximately 24 months]
Secondary outcome measures (4)
- Incidence and severity of AE [Time frame: Up to follow-up period, approximately 24 months]
- Cmax [Time frame: Up to follow-up period, approximately 24 months]
- Tmax [Time frame: Up to follow-up period, approximately 24 months]
- Overall Response Rate (ORR) [Time frame: Up to follow-up period, approximately 24 months]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- West China Hospital of Sichuan University — Chengdu
Identifiers
NCT: NCT06484777 · SHR-9539-101