Multiple MyelomaPhase 1NCT07490613
A Phase I Study of SHR-3836 in Patients With Multiple Myeloma
A Phase 1 study testing SHR-3836 administered as multiple doses. in people with Multiple Myeloma, run by Shanghai Hengrui Pharmaceutical 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-3836 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-3836 administered as multiple doses.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteChina
- Study dates
- 2 Jun 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-3836.
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
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Depei Wu
About this study
Official title: An Open-label, Multicenter, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SHR-3836 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-3836 in patients with multiple myeloma (MM).
- Conditions
- Multiple Myeloma
- Being tested
- SHR-3836 administered as multiple doses.
- 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-3836 administered as multiple doses.Drug
- In the dose escalation phase, doses are escalated sequentially from low to high levels.
- In the dose expansion phase, one or more selected dose levels are further evaluated.
| Study group | Role | What they receive |
|---|---|---|
| SHR-3836 for injection | Experimental | Not described Receives: Drug: SHR-3836 administered as multiple doses. |
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-3836
Measured: 24 months
Secondary outcomes (4)
Incidence and severity of adverse events (AE) of SHR-3836
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 posted24 Mar 2026
- Study start2 Jun 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 Shanghai Hengrui Pharmaceutical 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
- Masking
- None (open label)
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490613
- Sponsor's protocol ID
- SHR-3836-101
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 4 Jun 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 4 Jun 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-3836 in Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07490613
- Acronym / sponsor ID
- SHR-3836-101
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 24 Mar 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-3836 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
| Arm | Type | Receives |
|---|---|---|
| SHR-3836 for injection | Experimental | Drug: SHR-3836 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-3836 administered as multiple doses.* In the dose escalation phase, doses are escalated sequentially from low to high levels. * In the dose expansion phase, one or more selected dose levels are further evaluated. | Drug | SHR-3836 for injection |
Primary outcome
Determination of Phase II Dose (RP2D) of SHR-3836
Time frame: 24 months
4 secondary outcomes
Incidence and severity of adverse events (AE) of SHR-3836
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 4 Jun 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-3836 administered as multiple doses. in people with Multiple Myeloma, run by Shanghai Hengrui Pharmaceutical 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 4 Jun 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 Depei Wu (+0512-67976372, drwudepei@163.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-3836 (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 4 Jun 2026.