NCT06484777RecruitingPhase 1
A Clinical Study of SHR-9539 in Patients With Multiple Myeloma
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
Source: ClinicalTrials.gov · Last updated 16 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 138 (estimated)
- First submitted
- 26 Jun 2024
- Start date
- 7 Aug 2024
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Diseases
- Multiple myeloma
- NCT number
- NCT06484777
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 138
- From 7 Aug 2024 to the primary completion date, 31 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- Diagnosis of amyloidosis, plasma cell leukemia, Wahl's macroglobulinemia, or POEMS syndrome;
Lab values
- 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.
Other
- Central nervous system (CNS) involvement of MM；
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| West China Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.