A Phase I Study of SHR-3836 in Patients With Multiple Myeloma
An Open-label, Multicenter, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SHR-3836 in Patients With Multiple Myeloma
Shanghai Hengrui Pharmaceutical Co., Ltd.
99 participants
Jun 2, 2026
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria10
- 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
- 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
Exclusion Criteria13
- 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.
- 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.
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Interventions
* 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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07490613