Multiple MyelomaPhase 1NCT06484777
A Clinical Study of SHR-9539 in Patients With Multiple Myeloma
A Phase 1 study testing SHR-9539 for injection in people with Multiple Myeloma, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- SHR-9539 for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteChina
- Study dates
- 7 Aug 2024to 31 Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610000
Ting Niu, Doctor, +86-18980601242, Tingniu@sina.com
About this study
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
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.
- Conditions
- Multiple Myeloma
- Being tested
- SHR-9539 for injection
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-9539 for injectionDrug
SHR-9539 for dose escalation/dose extension
| Study group | Role | What they receive |
|---|---|---|
| SHR-9539 for injection | Experimental | Not described Receives: Drug: SHR-9539 for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
RP2D of SHR-9539 injection
Determination of the recommended phase 2 dose (RP2D) of SHR-9539 injection in patient with multiple myeloma.
Measured: Approximately 24 months
Secondary outcomes (4)
Incidence and severity of AE
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.
Measured: Up to follow-up period, approximately 24 months
Cmax
Maximum serum concentration
Measured: Up to follow-up period, approximately 24 months
Tmax
Time to reach maximum plasma concentration.
Measured: Up to follow-up period, approximately 24 months
Overall Response Rate (ORR)
ORR assessed by the IMWG response criteria.
Measured: Up to follow-up period, approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start7 Aug 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Suzhou Suncadia Biopharmaceuticals Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484777
- Sponsor's protocol ID
- SHR-9539-101
- Status last verified
- Apr 2026
- First submitted
- 26 Jun 2024
- Last updated
- 16 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06484777
- Acronym / sponsor ID
- SHR-9539-101
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Aug 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR-9539 for injection | Experimental | Drug: SHR-9539 for injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR-9539 for injectionSHR-9539 for dose escalation/dose extension | Drug | SHR-9539 for injection |
Primary outcome
RP2D of SHR-9539 injection
Time frame: Approximately 24 months
Determination of the recommended phase 2 dose (RP2D) of SHR-9539 injection in patient with multiple myeloma.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR-9539 for injection in people with Multiple Myeloma, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Wu (0518-82342973, yang.wu.yw96@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RP2D of SHR-9539 injection (time frame: Approximately 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.