NCT07490613

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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P75+ for phase_1 multiple-myeloma

Timeline
35mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Apr 2026Apr 2029

First Submitted

Initial submission to the registry

March 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2029

Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

March 18, 2026

Last Update Submit

March 18, 2026

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

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

    24 months

Secondary Outcomes (4)

  • 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

Study Arms (1)

SHR-3836 for injection

EXPERIMENTAL
Drug: SHR-3836 administered as multiple doses.

Interventions

SHR-3836 administered as multiple doses.DRUG

* 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.

SHR-3836 for injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Depei Wu

CONTACT

+0512-67976372drwudepei@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2026

First Posted

March 24, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2029

Last Updated

March 24, 2026

Record last verified: 2026-03

Locations

CN(1)