Not Yet RecruitingPhase 1

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

China99 participantsStarted 2026-04

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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
✓. Measurable disease as defined by serum/urine M-protein or serum free light chain
✓. Adequate bone marrow, hepatic, renal, and coagulation function

Exclusion criteria

✕. 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.
✕. Prior anti-tumor therapy within specified washout periods.
✕. Major surgery within 28 days prior to informed consent or planned during the study.

What they're measuring

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

Timeframe: 24 months

Trial details

NCT IDNCT07490613

SponsorShanghai Hengrui Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-04

Contact for this trial

Depei Wu

+0512-67976372 drwudepei@163.com

View on ClinicalTrials.gov More Multiple Myeloma trials