ClinicalTrials.gg
RecruitingNCT07490613Updated Jun 4, 2026

A Phase I Study of SHR-3836 in Patients With Multiple Myeloma

A Phase 1 interventional study of SHR-3836 administered as multiple doses. in Multiple Myeloma, sponsored by Shanghai Hengrui Pharmaceutical Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-04.

Sponsored by Shanghai Hengrui Pharmaceutical Co., Ltd. (part of Jiangsu HengRui Medicine Co., Ltd.) · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2026; still recruiting 5 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
99
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Multiple Myeloma

Browse trials for

03

In context

Multiple Myeloma

3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.

This study's planned enrollment of 99 is above the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd. is the lead sponsor of 61 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ≥ 18 years, male or female
  2. Expected survival ≥ 3 months
  3. performance status 0 or 1
  4. Diagnosed with active multiple myeloma per IMWG criteria
  5. multiple myeloma and refractory to the most recent .
  6. Disease progression or non-response to the most recent therapy
  7. as defined by serum/urine M-protein or serum free light chain
  8. Adequate bone marrow, hepatic, renal, and coagulation function
  9. Female participants of and male participants with partners of childbearing potential must agree to use effective
  10. Willing and able to provide written and comply with study procedures

Exclusion criteria

Exclusion Criteria:

  1. Diagnosis of amyloidosis, plasma cell leukemia, Waldenström's macroglobulinemia, or POEMS syndrome.
  2. Central nervous system involvement by tumor.
  3. History of ≥ Grade 3 CRS with prior T-cell redirecting therapy.
  4. Requirement for dialysis or plasmapheresis within 14 days prior to study drug.
  5. Prior treatment-related AEs not recovered to ≤ Grade 1 (except alopecia, peripheral neuropathy, or controlled endocrinopathies).
  6. Concurrent participation in another clinical study.
  7. Prior anti-tumor therapy within specified .
  8. Major surgery within 28 days prior to or planned during the study.
  9. within 4 weeks prior to first dose or planned during the study.
  10. Significant comorbidity that in the investigator's judgment would interfere with study participation or safety.
  11. Active disease (except controlled type I diabetes, hypothyroidism, or vitiligo).
  12. Active infection.
  13. Known or to SHR-3836.
Terms in these criteria, in plain language(12)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
99 participants (estimated)

Study arms

  • Experimental
    SHR-3836 for injection

    Drug: SHR-3836 administered as multiple doses.

Interventions

  • DrugSHR-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.

06

What researchers measure

Primary outcomes

  1. Determination of Phase II Dose (RP2D) of SHR-3836

    Time frame: 24 months

Secondary outcomes

  1. Incidence and severity of adverse events (AE) of SHR-3836

    Time frame: 24 months

  2. Maximum plasma concentration (Cmax)

    Time frame: 24 months

  3. Time to reach Cmax (Tmax)

    Time frame: 24 months

  4. Objective response rate (ORR)

    Time frame: 24 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Apr 2028, 22 months after the start.

Of 212 industry-sponsored phase 1 interventional studies under Multiple Myeloma, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 71. This study's planned 22 months is below that.

Counting every sponsor, half of 413 studies reached it within 50 months; a quarter within 33 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 18, 2026
First posted
Mar 24, 2026
StartActual
Jun 2, 2026
Primary completionEst.
Apr 2028
CompletionEst.
Apr 2029
Last update
Jun 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07490613
Responsible party
Sponsor
First posted
Mar 24, 2026
Start date
Jun 2, 2026
Primary completion
Apr 2028 (estimated)
Completion
Apr 2029 (estimated)
Last update
Jun 4, 2026

Study contacts

Depei Wu
Contact
drwudepei@163.com
+0512-67976372

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion