Actively Recruiting
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
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2026-04-16
138
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating SHR-9539 Injection in patients with multiple myeloma through a multicenter, open-label Phase I trial. The study aims to assess the safety, tolerability, how the body processes the drug (pharmacokinetics), its biological effects (pharmacodynamics), and its potential efficacy profile. This trial is designed to better understand SHR-9539's impact on multiple myeloma, a type of blood cancer, under the sponsorship of Suzhou Suncadia Biopharmaceuticals Co., Ltd. Participants will receive SHR-9539 via injection in a dose-escalation and dose-expansion format. This means that the dosage will be carefully increased and extended to find the appropriate dose to study. The treatment period includes initial dose escalation followed by a dose expansion phase to further evaluate the drug's effects at the selected dose. During the study, participants will be monitored for safety and treatment effects for approximately 24 months. Researchers will assess the recommended phase 2 dose (RP2D), record any adverse events, and measure drug concentration and timing in the body. They will also evaluate the overall response rate to the treatment. Regular assessments will include health evaluations and laboratory tests to track the participant's condition and treatment response throughout the study.
CONDITIONS
Brief Title
A Clinical Study of SHR-9539 in Patients With Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of signing the informed consent form
- Performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
- Documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria
- Life expectancy of at least 3 months
- Male and female participants with fertility must agree to use effective contraception during the study and for 3 months after last drug administration, have no fertility plans, and have a negative pregnancy test during screening
You will not qualify if you...
- Central nervous system involvement of multiple myeloma
- Diagnosis of amyloidosis, plasma cell leukemia, Wahl's macroglobulinemia, or POEMS syndrome
- History of Grade 3 or higher cytokine release syndrome related to T cell redirection therapies
- Other serious illnesses or conditions requiring treatment that could affect safety or data collection, including psychiatric illnesses, serious laboratory abnormalities, or social factors as determined by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 24 months
Participants receive SHR-9539 injections as part of dose escalation and dose extension to assess safety and effectiveness.
Visit schedule depends on dosing and assessments during treatment
Duration - Up to approximately 24 months
Participants are monitored for safety, pharmacokinetics, pharmacodynamics, and treatment response after completing SHR-9539 treatment.
Visits scheduled periodically during follow-up
Trial Site Locations
Total: 1 location
1
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610000
Actively Recruiting
Research Team
Y
Yang Wu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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