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A Phase I Study of SHR-3836 in Patients With Multiple Myeloma Phase 1 99 Open-Label

Not yet recruiting
Clinical Trial NCT07490613 is designed to study Treatment for Multiple Myeloma. This Phase 1 interventional study is not yet recruiting. Enrollment is planned to begin on April 1, 2026 until the study accrues 99 participants. Led by Shanghai Hengrui Pharmaceutical Co., Ltd., this study is expected to complete by April 1, 2029. The latest data from ClinicalTrials.gov was last updated on March 24, 2026.
Brief 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).
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

Conditions
Multiple Myeloma
Other Study IDs
  • SHR-3836-101
NCT ID Number
NCT07490613
Start Date (Actual)
2026-04
Last Update Posted
2026-03-24
Completion Date (Estimated)
2029-04
Enrollment (Estimated)
99
Study Type
Interventional
PHASE
Phase 1
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Sequential
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalSHR-3836 for injection
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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Determination of Phase II Dose (RP2D) of SHR-3836
24 months
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Incidence and severity of adverse events (AE) of SHR-3836
24 months
Maximum plasma concentration (Cmax)
24 months
Time to reach Cmax (Tmax)
24 months
Objective response rate (ORR)
24 months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  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

  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.
Shanghai Hengrui Pharmaceutical Co., Ltd. logoShanghai Hengrui Pharmaceutical Co., Ltd.
Study Central Contact
Contact: Depei Wu, +0512-67976372, [email protected]
1 Study Locations in 1 Countries

Jiangsu

The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, 215006, China
Depei Wu, Principal Investigator