New hope for Hard-to-Treat myeloma: experimental drug SHR-3836 enters human testing
NCT ID NCT07490613
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests a new drug called SHR-3836 in 99 adults with multiple myeloma that has returned or stopped responding to standard treatments. The main goals are to find the safest dose and check for side effects, while also seeing if the drug can shrink tumors. Participants must be in fairly good health and have measurable signs of myeloma.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 99 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Apr 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 18 years, male or female 2. Expected survival ≥ 3 months 3. ECOG performance status 0 or 1 4. Diagnosed with active multiple myeloma per IMWG criteria 5. Relapsed or refractory multiple myeloma and refractory to the most recent line of therapy. 6. Disease progression or non-response to the most recent therapy 7. Measurable disease 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 childbearing potential and male participants with partners of childbearing potential must agree to use effective contraception 10. Willing and able to provide written informed consent and comply with study procedures 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 washout periods. 8. Major surgery within 28 days prior to informed consent or planned during the study. 9. Live attenuated vaccine 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 autoimmune disease (except controlled type I diabetes, hypothyroidism, or vitiligo). 12. Active infection. 13. Known hypersensitivity or contraindication to SHR-3836.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The First Affiliated Hospital of Soochow University
RECRUITINGSuzhou, Jiangsu, 215006, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Cheap blood count ratios eyed as window into Myeloma's inflammatory grip
- Can a t-cell engager rescue myeloma that outsmarted CAR-T?
- Can myeloma treatment work without steroids?
- Double-Drug attack on Hard-to-Treat lymphomas
- Banking blood and bone marrow to decode plasma cell disorders
- Which scan sees hidden myeloma better: PET or MRI?