Multiple MyelomaPhase 1NCT07652281
A Clinical Study of SHR-5421 in Patients With Multiple Myeloma
A Phase 1 study testing SHR-5421 for Injection in people with Multiple Myeloma, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This is a Phase I, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of SHR-5421 in patients with multiple myeloma (MM). 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-5421 for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteChina
- Study dates
- 23 Jul 2026to Apr 2029
- 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, male or female.
- Expected survival ≥ 3 months.
- ECOG performance status 0 or 1.
- Diagnosed with active multiple myeloma per IMWG criteria.
- Relapsed or refractory multiple myeloma and refractory to the most recent line of therapy.
- Disease progression or non-response to the most recent therapy.
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- Measurable disease as defined by serum/urine M-protein or serum free light chain.
- Adequate bone marrow, hepatic, renal, and coagulation function.
- Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception.
- Willing and able to provide written informed consent and comply with study procedures.
Who cannot join
- Diagnosis of amyloidosis, plasma cell leukemia, Waldenström's macroglobulinemia, or POEMS syndrome.
- Central nervous system involvement by tumor.
- History of ≥ Grade 3 CRS with prior T-cell redirecting therapy.
- Requirement for dialysis or plasmapheresis within 14 days prior to study drug.
- Prior treatment-related AEs not recovered to ≤ Grade 1 (except alopecia, peripheral neuropathy, or controlled endocrinopathies).
- Concurrent participation in another clinical study.
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- Prior anti-tumor therapy within specified washout periods.
- Major surgery within 28 days prior to informed consent or planned during the study.
- Live attenuated vaccine within 4 weeks prior to first dose or planned during the study.
- Significant comorbidity that in the investigator's judgment would interfere with study participation or safety.
- Active autoimmune disease (except controlled type I diabetes, hypothyroidism, or vitiligo).
- Active infection.
- Known hypersensitivity or contraindication to SHR-5421.
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
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Jin Lu, +86-010-86491510, jin1lu@sina.com
Jin Lu
About this study
Official title: An Open-label, Multicenter, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SHR-5421 in Patients With Multiple Myeloma
This is a Phase I, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of SHR-5421 in patients with multiple myeloma (MM).
- Conditions
- Multiple Myeloma
- Being tested
- SHR-5421 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-5421 for InjectionDrug
SHR-5421 for injection.
| Study group | Role | What they receive |
|---|---|---|
| SHR-5421 Group | Experimental | SHR-5421 administered as multiple doses. Receives: Drug: SHR-5421 for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of Phase II Dose (RP2D) of SHR-5421
Measured: 24 months.
Secondary outcomes (4)
Incidence and severity of adverse events (AEs)
Measured: 24 months.
Maximum plasma concentration (Cmax)
Measured: 24 months.
Time to reach Cmax (Tmax)
Measured: 24 months.
Objective response rate (ORR)
Measured: 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start23 Jul 2026
- Primary completionApr 2028 (estimated)
- Study completionApr 2029 (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
- Sequential
- Model description
- This is a phase I, open-label, dose escalation and expansion study of SHR-5421 in patients with relapsed or refractory multiple myeloma.
- Masking
- None (open label)
- Enrolment
- 97 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
- NCT07652281
- Sponsor's protocol ID
- SHR-5421-101
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2026
- Last updated
- 30 Jul 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 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SHR-5421 in Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07652281
- Acronym / sponsor ID
- SHR-5421-101
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 97 participants (estimated)
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Jul 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 17 Jun 2026 (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 is a Phase I, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of SHR-5421 in patients with multiple myeloma (MM).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a phase I, open-label, dose escalation and expansion study of SHR-5421 in patients with relapsed or refractory multiple myeloma.
| Arm | Type | Receives |
|---|---|---|
| SHR-5421 Group | Experimental | Drug: SHR-5421 for InjectionSHR-5421 administered as multiple doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years, male or female.
- Expected survival ≥ 3 months.
- ECOG performance status 0 or 1.
- Diagnosed with active multiple myeloma per IMWG criteria.
- Relapsed or refractory multiple myeloma and refractory to the most recent line of therapy.
Key exclusion criteria (13 listed)
- Diagnosis of amyloidosis, plasma cell leukemia, Waldenström's macroglobulinemia, or POEMS syndrome.
- Central nervous system involvement by tumor.
- History of ≥ Grade 3 CRS with prior T-cell redirecting therapy.
- Requirement for dialysis or plasmapheresis within 14 days prior to study drug.
- Prior treatment-related AEs not recovered to ≤ Grade 1 (except alopecia, peripheral neuropathy, or controlled endocrinopathies).
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-5421 for InjectionSHR-5421 for injection. | Drug | SHR-5421 Group |
Primary outcome
Determination of Phase II Dose (RP2D) of SHR-5421
Time frame: 24 months.
4 secondary outcomes
Incidence and severity of adverse events (AEs)
Time frame: 24 months.
Maximum plasma concentration (Cmax)
Time frame: 24 months.
Time to reach Cmax (Tmax)
Time frame: 24 months.
Objective response rate (ORR)
Time frame: 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 30 Jul 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-5421 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 10 inclusion and 13 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 30 Jul 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 Junli Wang (+86-0518-82342973, junli.wang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of Phase II Dose (RP2D) of SHR-5421 (time frame: 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 30 Jul 2026.